Accelerate your career
at Kyowa Kirin

North America

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.

Summary:

The Associate Director, Biostatistician is responsible for managing and overseeing all aspects of statistical activities, including tasks performed by vendors, interfacing with in-house staff and in establishing and maintaining global standards procedures.

Essential Functions:

Statistical Activities
•    Lead the development of integrated statistical analysis plans for NDA/BLA/MAA submissions and responses to health authorities' (HA) information requests. Interpret and analyze results in a regulatory context.
•    Responsible for development of statistical sections of Protocols and statistical analysis plans, and interpretation of statistical analysis results for all active development studies.
•    Manage collaboration with Contract Research Organizations (CROs) and other vendors. Review, approve, and ensure the accuracy of statistical analysis plans, CRFs, and dataset structures. Ensure statistical tasks are performed to a high standard.
•    Ensure consistency across multiple clinical development studies in statistical design and analysis, contributing to the integrity and cohesion of Clinical Development Plans (CDPs).
•    Offer statistical expertise on project-related topics and resolve complex statistical challenges, ensuring data integrity and study goals are met.
•    Participate in presentation/publication and remain highly visible within the scientific community.
•    Provides SAS or R programming whenever needed and statistical analyses for publications and presentations of secondary study results of clinical trials.
•    Engage in the vendor selection process, reviewing and creating Requests for Proposals (RFPs), defining specific vendor requirements (systems, SOPs, training records), and ensuring alignment with project needs.

Internal Collaboration
•    Actively participate on Project Teams; Develop and Review protocols, statistical analysis plans, and Clinical Study Reports; Work closely with Medical Monitor(s) to develop and review SAP for logic, consistency, and medical appropriateness.
•    Review and provide expert input on study documents, including protocols, case report forms (CRFs), data set specifications, CSRs, and SAPs, ensuring they meet scientific, statistical, and regulatory standards.
•    Contribute to departmental initiatives focused on process building, process improvement, and the integration of new technologies to enhance efficiency and consistency across the organization.
•    Liaise and coordinate efforts to harmonize global procedures, processes, and standards, ensuring consistency and adherence to best practices across international teams and studies.

Requirements:

Education
MS in Biostatistics, Statistics or closely related discipline. Ph.D. highly preferred.

Experience
•    Ph.D. in Statistics with a minimum of five (5) years of experience or a Master’s in Statistics with a minimum of ten (10) years of experience within the biotech or pharmaceutical industry. 

•    Minimum four (4) years of experience in designing studies and analyzing data for clinical trials and/or early phase clinical pharmacology trials.

Technical Skills
•    Proficient with SAS programming and other statistical software (e.g., R, Python, etc.,). 
•    Familiarity with ICH guidelines (especially E9) and other regulatory guidance.
•    In-depth understanding of development, regulatory and commercial aspects of drug development. 
•    Strong written, verbal, and presentation skills, with the ability to effectively communicate complex concepts to diverse audiences.
•    Solid proficiency using Microsoft Office Suite including Word, Excel, and Power Point for documentation, analysis, and presentations. 

Working Conditions:

Requires up to 10% domestic and international travel

The anticipated salary for this position will be $180,000 to %190,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
•    401K with company matching
•    Discretionary Profit Sharing
•    Annual Bonus Program (Sales Bonus for Sales Jobs)
•    Generous PTO and Holiday Schedule which includes a Summer and Winter Shut-Down, Sick Days and, Volunteer Days
•    Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
•    HSA & FSA Programs
•    Well-Being and Work/Life Programs
•    Life & Disability Insurance
•    Concierge Service
•    Pet Insurance    
•    Tuition Assistance
•    Employee Referral Awards
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-TT1 #Hybrid #Remote

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The scope of the Global Organizational Planning and Strategy team under Global Planning Function includes, but not limited to the following:
•    Annual/Mid-/Long-term action plan management 
•    Setting the organizational strategy 
•    Building business foundation
•    Arranging organization structure
•    Identifying and addressing issues
•    Talent development

The Associate Director, Business Process Management, is responsible for enhancing operational efficiency and quality by developing, documenting, and optimizing robust global business processes. This role involves close collaboration with cross-functional business process owners to ensure alignment and consistency across the organization.

Success in this position requires a strong understanding of general corporate operations and industry-specific business practices, as well as the ability to analyze complex business architectures with quality-by-design thinking. Additionally, the Associate Director is expected to drive innovation through the application of digital solutions, supporting process streamlining and digital transformation initiatives.

Essential Functions:

The Associate Director for Business Process Management, the Global Organizational Planning and Strategy team position will serve as a member of the team to conduct assigned tasks such as but not limited to:
•    Improve efficiency and quality of business through creating and documenting robust global business processes underpinning the operation of high performing organization for drug development partnering with business process owners cross-functionally. 
•    Foster concept of end-to-end process-driven and data-driven business operation by continuous reflection and improvement; drive change management to instill the concept.
•    Identify and embed digital solutions for streamlining the process and bringing innovation through digital transformation. Leading and supporting global system/process implementation and administration for cross-functional or cross-regional use
•    Document control of the non-GxP document such as the rules and working instructions including communication with authors/reviewers, document storage, retrieval, version control, and access control
•    Lead operational excellence by analyzing business architecture, adopting external best practices and measuring performance.
•    This position requires flexibility in working hours to accommodate cross-regional collaboration and communication.

Requirements:

Education
•    Bachelor’s degree in business, science, engineering, math, or closely related field required; advanced degree and/or MBA preferred.

Experience
•    Minimum five (5) years of experience in business analysis, operational excellence, process improvement, or digital transformation required. Experience in Drug Development is preferred but not mandatory.

Technical Skills
•    Strong proficiency in Microsoft Office Suite including Word, Excel, and Power Point.
•    Proven track record of process management and process documentation with industry standard methodology (e.g. BPMN)
•    Broad understanding of clinical development, project management, regulatory, and commercialization of drug.
•    Solid analytical and problem-solving skills with the ability to identify and address issues effectively
•    Capable of managing multiple tasks and priorities simultaneously
•    Preferred: Familiarity with digital tools and technologies relevant to business process management
•    Business analysis skills and certification (e.g. CBAP) are a strong plus but not mandatory.

Non-Technical Skills
Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Excellent interpersonal and communication skills (written, verbal, listening, and presentation).Strong work ethic is required. Detail oriented and excellent follow through. Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment. Has a passion for personal learning and development to be able to grow with the company. Cultural sensitivity and ability to develop consensus within a multinational organization. Flexibility in working cross regionally.

Working Conditions:

Requires up to 10% domestic and international travel

The anticipated salary for this position will be $180,000 to $190,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
•    401K with company matching
•    Discretionary Profit Sharing
•    Annual Bonus Program (Sales Bonus for Sales Jobs)
•    Generous PTO and Holiday Schedule which includes a Summer and Winter Shut-Down, Sick Days and, Volunteer Days
•    Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
•    HSA & FSA Programs
•    Well-Being and Work/Life Programs
•    Life & Disability Insurance
•    Concierge Service
•    Pet Insurance    
•    Tuition Assistance
•    Employee Referral Awards
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-TT1 #Hybrid #Princeton

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

Responsible for managing and overseeing all aspects of data management (DM) for assigned projects, including managing staff, selecting and overseeing DM vendors, supervising tasks performed by vendors, assuring data quality, interfacing with in-house staff in establishing and maintaining global data standards and department procedures.

Essential Functions:

•    Strong understanding of Risk Based Quality Management.
•    High sensitivity to industry trends and the ability to leverage them in business
•    Accountable for all aspects of data management tasks from vendor selection to new drug application.
•    Conducting risk assessments related to data and designing data quality by mitigating risks.
•    Oversee all aspects of data management tasks performed by vendor, which include but not limited to: Review CRF, database and dataset structure, Data Management Plan, Data Review Guidelines and edit specifications; Assure dictionary versions are correct; Request specific project tracking reports; Qualify vendor personnel; Review queries; Oversee change order activities; Perform internal activities associated with database lock at vendor (e.g. SAE reconciliation, dictionary term reconciliation, external vendor’s data reconciliation and document collection).
•    Collaborating with an external vendor to create a Data Transfer Agreement.
•    Interface with internal and external staff: Participate on Project Teams; Review protocols, statistical analysis plans, monitoring guidelines and Clinical Study Reports; Work closely with Medical Monitor(s) to review CRF coding for logic, consistency and medical appropriateness.
•    Assure all clinical data is properly collected, cleaned and formatted, to assure data quality and data integrity for proper analysis and interpretation required for inclusion into reports and regulatory submissions.
•    Work closely with DM vendors to ensure timelines are met and communicate to Project Management as appropriate in order to achieve KPIs.
•    Archival of end-of-study documents as appropriate.
•    Responsible for budget planning for DM-related tasks, department budget planning, and budget performance tracking.
•    Supervise DM staff and manage DM resources
•    Support sub-function head of data management in hiring data managers
•    Negotiate with partner companies to obtain trial data. If there are gaps, develop alternatives to complete the submission materials.
•    Participate as a subject matter expert in Regulatory Submissions and Regulatory Audits.
•    Meet and discuss with Japanese HQ regularly, regarding global Data Management procedures, process and standards.
•    Staying updated on industry trends, proposing new Data Management strategies, and executing them independently.

Requirements:

Education
Bachelor's degree in science, Technology, Engineering, or Mathematics, and/or equivalent knowledge and experience

Experience
•    Minimum 10 years’ Clinical DM experience.
•    Minimum 5 years’ pharmaceutical company experience.
•    Minimum 2 years’ people management experience 
•    Multi Regional Clinical Trial experiences
•    Experience in hematological cancers or bone/mineral studies is highly desirable
•    Subject Matter Expert (SME) in FDA or EMA Inspections is highly desirable.

Technical Skills
•    Strong understanding of regulatory guidelines (and the related issues) (e.g. ICH/GCP) and the connection to DM deliverables (e.g. data quality and data integrity).
•    Strong understanding of Risk Based Quality Management.
•    Good understanding of Medical coding (MedDRA and WHO Drug dictionaries) to check consistency codes and upgrade.
•    Strong familiarity with CDISC (CDASH/SDTM).
•    Good understanding of Computerized System Validation
•    Proficient in systems and tools used in clinical trials (EDC, BI tools).
•    Proficient in Microsoft tools (Excel, Word, PowerPoint, etc.).
•    Basic knowledge of Decentralized Clinical Trials(DCT) and AI(Artificial Intelligence)

Working Conditions:

Normal office environment with prolonged sitting and extensive computer work. Work in the office required at least 2 days a week
There are international calls/meetings once or twice a week.
Requires up to 10% of domestic and international travel

The anticipated salary for this position will be $180,000 to $190,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
•    401K with company matching
•    Discretionary Profit Sharing
•    Annual Bonus Program (Sales Bonus for Sales Jobs)
•    Generous PTO and Holiday Schedule which includes a Summer and Winter Shut-Down, Sick Days and, Volunteer Days
•    Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
•    HSA & FSA Programs
•    Well-Being and Work/Life Programs
•    Life & Disability Insurance
•    Concierge Service
•    Pet Insurance    
•    Tuition Assistance
•    Employee Referral Awards
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-TT1 #Hybrid #Princeton

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary of Job:

The Associate Director, Commercial Analytics, will support the Kyowa Kirin, North America franchise teams (US and Canada) in providing business insights and holistic solutions to help steer strategic direction and improve execution efficiency. This role will support the launch of Ziftomenib and collaborate across multiple functions within and outside Commercial Operations to leverage data and analytics to drive strategic and execution excellence. This role is expected to be proficient in communication, strategic thinking, business acumen, and analytical ability and be able to provide cross-franchise support to peers in certain areas, such as Incentive Compensation design and field force restructure initiatives.  Specifically, this position will be accountable for insights-driven performance reporting, such as KPIs and advanced analytics (e.g., predictive modeling, marketing mix resource allocation), and daily ad-hoc analysis from different business stakeholders. This individual will partner and collaborate with Marketing, Sales, Market Access, Sales Operations, and Finance to provide analytics that is aligned with Kyowa Kirin’s strategic imperatives. This person must be comfortable with operating in a fast-paced environment.

Essential Functions: 

• Immersion in the strategic and tactical plans of the franchise to proactively support performance measurement and reporting needs.
• Develop strong working relationships with Sales and Marketing leads as well as different functional leads within BI&A to maximize the value of various analytical capabilities to drive overall business performance across franchises.
• Connect the dots across Sales & Marketing, Forecasting and Analytics to drive a common story on brand performance and execution of tactics.
• Demonstrate proactive curiosity challenging status quo business thinking and leveraging best practices in analytics to bring in fresh insights.
• Demonstrated ability to think creatively and strategically, to build partnerships cross-functionally, and the flexibility to work in a dynamic and fast-paced environment
• Develop performance reporting and provide ad hoc, deep dive analysis in secondary analytics as required to uncover and understand market and competitive dynamics to identify opportunities and risks in a timely manner.
• Utilize various claim data sources to identify patients at different stages of their journey in the disease state.
• Align current data sources for both strategic and operational use in a cost-effective way.
• Perform return on investment (ROI), impact analysis and marketing mix optimization to help the business franchise efficiently allocate resources to maximize brand potential
• Build advanced and predictive / ML data analytics capabilities to drive commercial excellence across functions
• Design and execute advanced analytics, including predictive modeling, segmentation, and customer journey analysis.
• Leverage big data, advanced analytics tools, and platforms to uncover commercial opportunities and optimize resource allocation.
• Keep abreast of market and industry developments and incorporate applicable trends into competitive dynamics.

Job Requirements:

Education

Bachelor’s degree; Advanced degree in Economics, Statistics, or any related field preferred

Experience

• 6-8 years of experience in analytics, market insights, or related roles in the pharmaceutical or healthcare industry.
• Experience in using data to inform commercial strategies within the pharmaceutical industry is highly preferred.
• Experience in brand performance analytics, physician behavioral segmentation, marketing mix optimization, promotion response modeling, targeting and sales force sizing and structure, and test/control ROI analysis
• Proven track record of working with large datasets, advanced analytics techniques, and data visualization tools (e.g., Tableau, Power BI).
• Extensive knowledge of various industry data sources such as IQVIA Rx data (xPonent, xPonent Plantrak, DDD, and HCOS) or Symphony Rx data (Prescriber, Prescriber/Payer, PHAST), Patient Claims data, Patient Longitudinal data or other types of patient and physician level data.
• Knowledge of Oncology disease state and CRM platforms would be a plus

Technical Skills

• Strong analytical skills with experience in data mining, statistical analysis, and predictive modeling.
• Proficient in tools such as SQL, SAS, R, Python and Excel for data analysis and PowerPoint for stakeholder presentations.

Non-Technical Skills

Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Strong interpersonal and communication skills. A strong work ethic is required. Excellent communication and presentation skills, with the ability to translate complex data into actionable insights for non-technical stakeholders. Strong project management and leadership abilities, with experience leading cross-functional teams. Ability to thrive in a fast-paced, dynamic environment with a strong attention to detail. Detail-oriented and excellent follow-through. Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high-growth environment. Has a passion for personal learning and development to be able to grow with the company. Cultural sensitivity and ability to develop consensus within a multinational organization.

Physical Demands: Normal office environment with prolonged sitting and extensive computer work.

Working Conditions: No travel is required

The anticipated salary for this position will be $162,400 to $212,100.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company matching
• Discretionary Profit Sharing
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-JC1

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario

****This position is a multi-state territory

****Ideal Applicants would reside near a major city & airport

Summary of Job

The Associate Director, Medical Value and Outcomes Liaison serves as the medical scientific lead for population-based healthcare decision makers to facilitate scientific exchange on disease state management and the value of Kyowa Kirin’s Oncology products, to provide insights to internal teams on key evidence gaps relevant to healthcare decision-makers, and to identify/facilitate research, education, and other collaborations per applicable SOPs.

This role will be responsible for developing and implementing customized medical account plans to address medical needs and opportunities for scientific partnerships in alignment with medical strategies and tactics. A key responsibility will be to facilitate scientific exchange on disease state management and the clinical, real-world economic evidence demonstrating the value Kyowa Kirin products to inform healthcare decision making and improve patient outcomes.

Essential Functions: 

• Serve as medical scientific lead for assigned healthcare accounts and organizations.
• Identify, develop and maintain credible scientific partnerships with key medical, pharmacy, quality & health economics/outcomes/analytics healthcare decision-makers and opinion leaders within assigned accounts.
• Lead development and execution of customized medical account plans for assigned accounts in alignment with current Kyowa Kirin medical plan and per approved policies, procedures and guidelines.
• Facilitate scientific exchange, education and provide medical, health policy, and health economic information (e.g., clinical presentations, dossier, budget impact models, etc.), and tailor information to meet the evidence needs of healthcare decision-makers.
• Collect and share customer insights and evidence gaps that help to inform and advance product portfolio development and customer engagement, including medical strategy, customer educational needs, scientific/health outcomes communications, and research priorities.
• Develop key medical contacts related to clinical, evidence-based disease management/health outcome initiatives, aligned with overall medical strategy.
• Identify key contacts with applicable national/regional/local medical, payer, and advocacy associations.
• Provide support for Kyowa Kirin scientific advisory boards and symposia. Attend and participate as appropriate in corporate and scientific conferences.
• Work cross-functionally with HEOR and Market Access teams as well as field commercial & MSL teams when needed and as appropriate, to coordinate engagement of and response to customers’ medical/scientific needs.
• Provide input to the MVO Team for the development and delivery of field tools, resources, materials and training (e.g. product dossier, economic models, slide kits, articles, review summaries etc.)
• Participate in internal cross-functional teams to provide input on evidence needs, educational opportunities, and resources.

Job Requirements: 

 Education

• Advanced degree required; Doctoral degree - MD, PharmD, or PhD (clinical) strongly preferred; MBA or additional degree in health economics, health outcomes, public health or health policy is a plus.

Experience

• This position requires a minimum of five (5) years of relevant industry experience, including Medical Affairs
• Managed care (e.g., medical/clinical executive within managed healthcare organization) or similar Outcomes experience within the pharmaceutical industry (e.g., MVO, HEOR/HEVA/RWE) understanding with 2-3 years required.
• Clinical and/or pharmaceutical industry experience and displayed proficiency in therapeutic fields that align to the product portfolio supported strongly preferred (oncology).

Technical Skills

• Demonstrates proficiency in understanding and knowledge of the current US healthcare system, healthcare delivery, and biotechnology drug/device development process.
• Knowledge of HEOR disciplines and understanding of biostatistics and evidence-based medicine required (i.e. research methodology, developing clinical protocols, clinical reports, etc.).
• Excellent interpersonal, communication, and presentation skills required.
• Excellent organizational skills and the ability to prioritize and work effectively in a constantly changing environment in both an independent and collaborative manner.
• Demonstrates a customer service mindset and the ability to gain insights and identify customer needs and opportunities.
• Demonstrates excellent strategic thinking and business acumen.
• Demonstrated ability and knowledge to effectively communicate medical, scientific and business information to internal and external stakeholders.
• Proficient in MS Office Suite.

Non-Technical Skills

• Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Strong interpersonal and communication skills. Strong work ethic is required. Detail oriented and excellent follow through. Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment. Has a passion for personal learning and development to be able to grow with the company. Cultural sensitivity and ability to develop consensus within a multinational organization.

Physical Requirements:

• Normal office environment with prolonged sitting and extensive computer work

• Requires up to 70% domestic and/or international travel (as required)

The anticipated salary for this position will be $190,100 to $ 247,100.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company matching
• Discretionary Profit Sharing
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes a Summer and Winter Shut-Down, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-PE1

#LI-Field

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The Associate Scientist, Discovery Core Function will support Kyowa Kirin’s cell therapy pipeline programs in a highly collaborative environment. This position will play a key role in developing next-generation cell and gene therapy programs by providing support to pipeline projects and evaluating and implementing new technologies.

Essential Functions:

•    Support Cell and Gene Therapy pipeline projects by working with Project Leads to enable gene editing and generate new molecular workflows. 
•    Serve as a Project Lead for technology themed projects if needed
•    Identify, evaluate, and implement new gene editing technologies
•    Contribute scientific and technical knowledge to project and support teams
•    Design, initiate, and optimize molecular, cell based, and analytical methods to support the Research, Technical Operations, and In Vivo Pharmacology teams
•    Maintain compliance with regulatory guidelines and internal standards, and prepare necessary documentation for project reviews (proposals, monthly, quarterly, annual, or study reports), patent applications, publications, and/or animal, biosafety, or human subject protocols.
•    Present research at project meetings and efficiently record experiments and data in laboratory notebooks, databases and monthly reports.

Requirements:

Education

BS required, MA/MS preferred in a related scientific discipline. Knowledge and background in Molecular Biology, Bioengineering, Immunology, Hematology-Oncology is a plus.

Experience

8 years of hands-on experience and in-depth knowledge of cell and gene therapy techniques and gene editing is required. 

Extensive experience in gene editing technologies, including CRISPR, base editing, prime editing, or transposase/recombinase-based editing is required. 

Strong background in molecular biology, with practical experience in NGS, molecular analytical development, gene editing design, and molecular cloning.
 
Expertise in cell culture methodologies, development, and characterization of cell therapy products including HSCs, iPSCs, and/or CAR-T cells. 

Extensive experience in the molecular characterization of cell therapies, with a strong preference for expertise in NGS. 

Familiarity with CAR design, engineering, screening, and assay development is highly desirable. Experience in developing high-throughput screening platforms for cells, proteins, or antibodies is preferred. 

Background in antibody/protein engineering, protein production, and purification is highly preferred. 
Experience in virus production, transduction, and analytics is a valuable plus.

Technical Skills

Strong knowledge of industry standard gene editing techniques and analytics including CRISPR, guide RNA design and screens, indel analysis, knock-out and knock-in analysis, NGS, ddPCR. 

Solid understanding of cellular, molecular, and immunological techniques including cloning, ELISA, multi-color flow cytometry, in vitro functional assays, cell based assays, reporter assays. 

Experience in cell engineering processes including knowledge of cell line generation workflows and experience developing therapeutic engineered cells such as CAR-T.

Expertise in cell culture techniques including culture of primary cells, iPSCs, HSCs, and cell lines from multiple species and cell manipulation techniques including transfection, nucleofection, and transduction.
 
Experience with cell characterization including multicolor flow cytometry, FACS, MACS, and single cell isolation techniques. 

Experience in antibody or protein production, purification, and analysis is a plus. 

Proficient in MS Office Suite.

The anticipated salary for this position will be $120,000 to $125,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
•    401K with company matching
•    Discretionary Profit Sharing
•    Annual Bonus Program (Sales Bonus for Sales Jobs)
•    Generous PTO and Holiday Schedule which includes a Summer and Winter Shut-Down, Sick Days and, Volunteer Days
•    Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
•    HSA & FSA Programs
•    Well-Being and Work/Life Programs
•    Life & Disability Insurance
•    Concierge Service
•    Pet Insurance    
•    Tuition Assistance
•    Employee Referral Awards
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-TT1 #La Jolla #On-Site

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.

Job Purpose:

The position of Director, Forecasting will be a critical business partner with the brand and senior leadership for developing forecasts, profiling opportunities/risks, and identifying strategies for how to manage performance.  Specifically, this role will develop and lead a franchise-wide forecast process to support short-term and long-term business planning, LE changes, and execution. This individual will partner and collaborate with every function including but not limited to Marketing, Sales, Market Access, Market Research, Commercial Analytics, Sales Operations, and Finance. This leader will have the opportunity to define and implement a new forecasting capability for a dynamic, growing company focused on brain health.

This person must be comfortable with operating in a fast-paced “start-up” environment and capable of juggling multiple projects to deliver quality and accurate results in a timely manner.

Key Responsibilities:

• Lead the forecasting process and capability for the North American (NA) business across pre-launch and in-line products.
• Ownership of all short-term and long-term forecasts for commercialized and pipe-line products while working closely with the internal stakeholders (Finance, Marketing, Sales, Sales Operations) to determine planning, and product valuations
• Deliver objective forecasts for NA brands with profiling of opportunities/risks and proactive identification of strategies for how to manage them.
• Collaborate across NA Commercial teams as well as the Global Forecasting team to develop key assumptions and scenario planning.
• Manage fact-based approaches and processes as inputs to forecasting, such as epidemiology, brand share estimation, market access, and competitive impacts.
• Support forecasting input needs for Field Incentive Compensation planning.
• Track forecast accuracy and brand performance against key performance indicators (KPI).
• Define and implement strong forecasting standards and processes aligned with the business planning process.
• Provide ad hoc analysis to Marketing and Senior Management as requested.
• Have the ability to lead and influence stakeholders based on objective evidence by utilizing EPI data and analog identification and application.
• Role will also be responsible for ensuring competitive market events are formally and proactively identified, tracked, and assessed on a timely basis. Keeps abreast of news that could impact forecast drivers e.g. industry and competitive intelligence
• Be an integral part of the business planning process with stakeholders. Participate as a subject matter expert (SME) for Forecasting by challenging assumptions and identifying key risks and opportunities
• Evaluates and recommend the most appropriate sources for forecast model inputs, including epidemiology sources, prescription and prescriber databases, primary and secondary research, and scientific literature
• Contribute to the annual strategic plan for each franchise
• Guides the design of required market research studies to validate forecast assumptions, architecture, and patient populations
• Collaborated with HEOR and Commercial Analytics to determine what secondary data are needed to info internal company guidance
• Competent in data analytics (including pulling data from a data warehouse) relevant to forecast
• Ensure forecasts address the impact of critical events, are logically designed and well documented in the forecast model, and represent consensus decision-making among key stakeholders
• Provide strategic commercial advice and counsel as related to the overall scope

Position Requirements:

Education

• Minimum of a BS degree is required preferably in Business or Business Mathematics. Advanced degrees such as MBA preferred

Experience

• 8+ years of relevant experience in a forecasting function in a pharmaceutical/biotech company or consulting firm.

• Experience in the Pharmaceutical/Biotech/Life Sciences field(s) required. A high degree of understanding of the pharmaceutical supply chain, including manufacturers, wholesalers, chains, and payers.
• Experience with pharmaceutical data sources, such as IQVIA NSP, NPA, and epidemiology data sources.
• Expertise in market research is a plus.
• Experience working with all levels of management and consulting with key business stakeholders.
• Strong team player that has a customer service approach and is solution-oriented.
• Strong work ethic to handle ad hoc requests to deliver accurate and meaningful results on a tight deadline
• Process high resilience and agility as well as a keen analytical mindset and curiosity
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Excellent written and verbal (including listening) communication skills, problem-solving/resolution skills, and customer focus.
• Extensive experience in Forecast Pro and Monte Carlo simulation.
• Demonstrated ability to lead strategically, drive performance, build alignment, inform, and negotiate. This candidate will also have demonstrated initiative, creativity, and ability to work in complex, rapidly changing & ambiguous environments.
• Demonstrated ability to influence stakeholders; Proven ability to collaborate cross-functionally.

• Strong Excel and PowerPoint skills are required and can design the presentation deck to present complexity succinctly and meaningfully.

Physical Demands:

Normal office environment with prolonged sitting and extensive computer work

Working Conditions:

Requires 5% domestic and international travel

The anticipated salary for this position will be $230,000 to $245,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company matching
• Discretionary Profit Sharing
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes a Summer and Winter Shut-Down, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Long-Term Incentives
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Drive Princeton, NJ 08040 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

#LI-JC1

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The Project Manager, Global Regulatory Affairs Compliance and Planning will lead or support regional and global projects by effectively delivering assigned projects within GRA on time and within budget.  This individual will support the development of performance metrics and tracking mechanisms for timely monitoring and reporting of project performance.

Essential Functions:

The Project Manager, Regulatory Affairs Global Compliance and Planning is responsible for driving implementation of and adherence to best practices in project management.

•    This role will be a regional NA lead for Global Compliance and Planning and be responsible for ensuring global compliance and planning initiatives are implemented locally when applicable.  
•    The Project Manager will lead or support projects within the Global Compliance and Planning function and other appropriate project management initiatives within RA.
•    This role requires close partnership between global and regional regulatory functions as well as cross functional stakeholders such as QA, PV, and IT.  
•    This individual will partner with GRA Compliance and Planning team members to deliver on the strategy of achieving industry leadership, process efficiency, standardization, and ingraining a cultural mindset of continuous improvement.
•    The Project Manager will lead the project planning process and ensure strategic business objectives are met by the most efficient use of budget and resources.  This role will be required to think outside the box in developing a strategy and executing on a project effectively.  
•    This role will lead GRA risk management tracking initiatives. 
•    Support regulatory audits and inspections. Ensure effective processes are in place for tracking CAPAs, deviations.
•    Lead cross functional and regional collaborations to create harmonized processes and SOPs, including conducting a GAP analysis. 
•    This individual will develop performance metrics and conduct timely monitoring and reporting of project performance.
This role will be responsible for driving excellence in the execution of project role out and maintenance.

Requirements:

Education
Bachelor’s degree.  PMP Certified Prior experience in Life sciences industry (Pharmaceutical, Medical Device, or Bio-Tech) is beneficial but not required.

Experience
7+ years of pharmaceutical experience.  Broad understanding of pharmaceutical development, Regulatory Affairs, Quality Assurance, Safety and Commercial.  Experience 
managing cross-functional project teams in a global business
environment is required. Experience implementing change management would also be an important experience for this role.  

Technical Skills
Proficient in MS Office Suite (e.g, Microsoft Project, Powerpoint, Excel).

Non-Technical Skills
Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Strong interpersonal and communication skills. Strong work ethic is required. Excellent problem-solving skills. Detail oriented and excellent follow through. Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment. Has a passion for personal learning and development to be able to grow with the company. Cultural sensitivity and ability to develop consensus within a multinational organization.

Working Conditions:

Requires up to 5% domestic and international travel

The anticipated salary for this position will be $155,000 to $170,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company matching
• Discretionary Profit Sharing
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Long-Term Incentives
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-TT1 #Hybrid 

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary of Job:

The position of Head, Forecasting will be responsible for evolving Kyowa Kirin’s capabilities in forecasting, including developing strategy related to forecasting methodologies, processes, and technologies that will enhance decision-making and planning across the organization. This role will partner closely with cross-functional stakeholders (e.g., Marketing, Sales, FP&A) to optimize estimation and articulation of the commercial opportunity. This role will have management responsibility and must have experience in presenting to executives and be comfortable with operating in a fast-paced “start-up” type of environment and capable to juggle multiple projects to deliver quality and accurate results in a timely manner.

Key Responsibilities:

• Leading development of North American forecasts across in-line and pre-launch products and indications, as well as guiding and maintaining forecast models across regions
• Driving consolidation and delivery of the forecast narrative to senior leadership
• Proposing best-in-class methodology, process improvements, and technology solutions, then getting buy-in from cross-functional leaders and leading implementation of such solutions
• Integrating secondary data analyses and primary market research insights to support forecast assumptions
• Ownership of all short-term and long-term forecasts for commercialized and pipe-line products while working closely with the internal stakeholders (Finance, Marketing, Sales, and Pricing to determine planning, and product valuations
• Deliver objective forecasts for NA brands with profiling of opportunities/risks and proactive identification of strategies for how to manage them.
• Collaborate across NA Commercial teams as well as the Global Forecasting team to develop key assumptions and scenario planning.
• Manage fact-based approaches and processes as inputs to forecasting, such as epidemiology, brand share estimation, market access, and competitive impacts.
• Have the ability to lead and influence stakeholders based on objective evidence by utilizing EPI data and analog identification and application.
• Be an integral part of the business planning process with stakeholders. Participate as a subject matter expert (SME) for Forecasting by challenging assumptions and identifying key risks and opportunities
• Ensure forecasts address the impact of critical events, are logically designed and well documented in the forecast model, and represent consensus decision-making among key stakeholders
• Provide strategic commercial advice and counsel as related to overall scope

Requirements:

Education

• Minimum of a BS degree is required preferably in Business or Business Mathematics. Advanced degree such as MBA preferred

Experience

• 12+ years of leadership experience in a forecasting function in a pharmaceutical/biotech company or consulting firm.

• Expertise in developing product forecasts, market assessments, and competitive intelligence analyses
• Proven track-record of working with senior leadership/executives on forecast development and communication
• Strong people leader capable of inspiring and motivating forecasters to achieve excellence in delivering against team objectives while sustaining high employee engagement
• Strong quantitative and analytical skills, with the ability to translate complex data into actionable insights
• Collaborative and influential leadership style, with the ability to build strong partnerships across the organization
• Experience with pharmaceutical data sources, such as IQVIA NSP, NPA, claims data, and epidemiology data sources.
• Expertise in market research is a plus.
• Strong work ethic to handle ad hoc requests to deliver accurate and meaningful results on a tight deadline
• Process high resilience and agility as well as a keen analytical mindset and curiosity
• Excellent written and verbal (including listening) communication skills, problem-solving/resolution skills, and customer focus.
• Strong Excel and PowerPoint skills are required and are able to design the presentation deck to present complexity in a succinct and meaningful way.
• Demonstrated ability to lead strategically, drive performance, build alignment, inform, and negotiate

Physical Demands: Normal office environment with prolonged sitting and extensive computer work

Working Conditions: Requires 5% domestic and international travel

The anticipated salary for this position will be $219,500 to $286,600.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company matching
• Discretionary Profit Sharing
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Long-Term Incentives
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.

As a Business Technical Specialist, you will lead the North America & North Carolina manufacturing site ICT team in configuration, implementation, deployment and operational support of manufacturing site’s QC IT applications (i.e. LIMS, ELN & Other Lab Instrument Software and System / Instrument Integrations). Your responsibilities will include supporting SDLC/ GxP validation activities related to implementation and change controls of QC IT software systems / integrations. Provide functional / technical expertise on system features, system functionality, access/security controls, master data and understanding of the business processes. This role will act as a System Administrator as needed (set up new users and manage security roles), coordinate the needs of QC functional areas and lead LIMS configurations for key business processes in LIMS system related to compliance processes, instrument calibration, quality operations, environment monitoring, CoA, stability testing, vendor compliance, manage inventory, design of queries and report, develop product sampling/test plan.

This role reports into the Director, ICT, Site Lead

•    Expertise in LIMS application processes, specifically LabVantage
•    Proficiency in LIMS interfacing, navigation, and customization to streamline workflows and enhance user experience
•    Experience in leading projects to conclusion, making recommendations for improved outcomes.
•    Strong understanding and application of ITIL processes and best practices, with the ability to independently drive continuous improvement initiatives
•    Experience with ITSM tools and frameworks, leveraging them to optimize service delivery and align IT support with business needs
•    Demonstrated independence in diagnosing and resolving complex technical issues, applying sound judgment and critical thinking to identify root causes and implement effective solutions.
•    In-depth knowledge of troubleshooting methodologies and the ability to proactively address and mitigate recurring technical challenges
•    Extensive experience with system administration tasks, including advanced configuration, performance tuning, and optimization to support business-critical applications
•    Strong understanding of security best practices, risk management, and compliance standards, ensuring robust protection of business assets and data
•    Excellent communication and interpersonal skills, with a focus on high-level business partnership and aligning IT support with organizational goals
•     Ability to manage complex customer inquiries and provide tailored, high-quality solutions that enhance employee experience and business performance
•    Advanced capability in creating and maintaining detailed technical documentation, ensuring knowledge sharing and alignment across teams
•    Experience in generating, analyzing, and presenting actionable technical reports to senior leadership, contributing to strategic decision-making
•    High level of customer service focus, consistently fostering positive employee and business partner relationships, and ensuring a seamless IT experience for all end users

Education
Associate's or Bachelor's degree in Information Technology, Computer Science, or a related field.

Experience
At least 3 years of hands-on IT support experience, including troubleshooting complex issues, system management, and working directly with end-users and business partners; Experience in IT Project Management; Proven ability to thrive in ambiguous, fast-paced environments; possess a strategic mindset and Experience with GMP, GDP, and biopharma manufacturing facilities is a plus.

Technical Skills
Proficient in MS Office Suite.

Non-Technical Skills
Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Strong interpersonal and communication skills. Strong work ethic is required. Detail oriented and excellent follow through. Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment. Has a passion for personal learning and development to be able to grow with the company. Cultural sensitivity and ability to develop consensus within a multinational organization.
Normal office environment with prolonged sitting and extensive computer work.

Work is 100% on-site.  This is not a hybrid or remote role.  

Requires up to 10% domestic and international travel

The anticipated salary for this position will be $83,700 to $108,800.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
•    401K with company matching
•    Discretionary Profit Sharing
•    Annual Bonus Program (Sales Bonus for Sales Jobs)
•    Generous PTO and Holiday Schedule which includes a Summer and Winter Shut-Down, Sick Days and, Volunteer Days
•    Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
•    HSA & FSA Programs
•    Well-Being and Work/Life Programs
•    Life & Disability Insurance
•    Concierge Service
•    Pet Insurance    
•    Tuition Assistance
•    Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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