Current job openings with Kyowa Kirin North America
Kyowa Kirin is a global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in three disease areas: rare diseases; bone and mineral disease; and hematological cancers and diseases.
Kyowa Kirin North America has grown to include five locations, including offices in New Jersey and Canada, a research facility in California, and a new North Carolina manufacturing plant under construction and opening in 2027. Our focus is on drug discovery, product development, and commercialization. Together, we work as a close-knit team to understand clinical needs and advance innovations that can profoundly impact patient lives.
29 jobs found
Associate Director, Clinical Data Management
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
Associate Director, Commercial Analytics
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
Associate Scientist I- Cell and Gene Therapy
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
Automation Validation Engineer III
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.
The Automation Validation Engineer III will lead the Commissioning, Qualification, and Verification (CQV) of automated systems supporting the NC Manufacturing Facility. After project implementation, you will continue to lead validation activities related to system modifications and routine operations, ensuring sustained compliance of all validated systems.
As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.
Reporting Relationship: Engineering AD, Site CQV Lead
Essential Functions:
Technical Skills, Knowledge, and Experience
- Establish and develop the automation validation program for the Sanford manufacturing site, ensuring alignment with site goals and regulatory expectations.
- Lead validation activities for all site automated systems, including the Process Control System (PCS), Data Historian, Environmental Monitoring System (EMS), and Manufacturing Execution System (MES).
- Drive the execution of automation system validation efforts in partnership with cross-functional capital project leads, achieving “Operational Qualification (OQ) Complete” status for the facility and its systems by Q1 2027.
- Once the site becomes operational, lead the ongoing maintenance, periodic review, and continuous improvement of validated automation and computerized systems to ensure sustained cGMP compliance and adherence to internal procedures and global regulatory requirements.
- Provide technical leadership for future capital projects, system expansions, and technology implementations—ensuring automation validation strategies align with site and global requirements, uphold industry best practices, and support a state-of-the-art, compliant facility.
Subordinates: Individual contributor with the opportunity to potentially lead or coordinate task teams.
Job Requirements:
Education
- Bachelor’s degree in a technical field (e.g., Engineering, Computer Science, or related discipline) required.
- Formal training in GMP and safety practices is essential.
Experience
- Minimum of 3 years of experience in automation validation or automation engineering within biopharma manufacturing or capital projects.
- Strong knowledge of cGMP regulations and GAMP principles required.
- Prior leadership experience in automation or validation is preferred.
- Experience with technology transfer is a plus.
- Greenfield experience—particularly in capital project validation or the startup and operation of a biopharmaceutical manufacturing facility—is a plus.
Technical Skills
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
- Familiar with automation and manufacturing systems such as:
- MES, PCS, EMS, BMS
- DeltaV, PLC, SCADA
- Historian systems (e.g., Canary Labs)
- POMS, Ignition
- Platforms from Emerson and Schneider Electric
Non-Technical Skills
Results-oriented and able to navigate ambiguity, you set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational objectives. Respond promptly, take accountability, and manage tasks efficiently. Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges. Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment. Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness. Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset. Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by recognizing achievements and encouraging a healthy work-life balance. Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions. Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.
Physical Demands: Initially working on a construction site and ultimately in a biotech manufacturing site in Sanford, NC.
Work is 100% on-site. This is not a hybrid or remote role.
Working Conditions: Requires up to 10% domestic and limited international travel.
The anticipated salary for this position will be $106,300 to $138,800. 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.
#LH-SH1
Computerized Maintenance Management System (CMMS) Administrator
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.
The CMMS Administrator will support our facilities and maintenance operations in a GMP-regulated life sciences environment. The ideal candidate will be responsible for managing the CMMS to ensure compliance, data integrity, and the efficient scheduling and tracking of maintenance activities for critical equipment and infrastructure.
As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.
This role reports to the Sr. Manager, Maintenance and Facility Services
Technical Skills
• Administer and maintain the Computerized Maintenance Management System (CMMS) to support preventive, corrective, and predictive maintenance programs.
• Develop, update, and manage asset records, PM schedules, work orders, and maintenance history in the CMMS.
• Work with IT and CMMS vendors to troubleshoot technical issues and implement improvements.
• Generate periodic reports and KPIs related to maintenance performance, equipment reliability, and compliance.
• Schedule calibrations, maintenance, and vendor PMs
• Maintain data integrity with new assets, moves, and retirements.
Administrative
• Provide software training to end users and new administrators and serve as a liaison for problem-solving and escalation
• Lead or participate in system upgrades, validation, and configuration changes, ensuring compliance with 21 CFR Part 11 and other relevant regulations.
• Support regulatory audits by providing documentation, maintenance history reports, and CMMS data as needed.
• Train users on CMMS functionality, best practices, and data entry standards.
This is an Individual contributor position with the opportunity to potentially lead or coordinate task teams.
Education
• 2-4 years relevant CMMS experience and High School diploma or equivalent.
• Associates or Bachelor’s degree preferred.
Experience
• 2-4 years experience working within a CMMS environment preference given to those with SAP or Microsoft Dynamic experience.
• Experience with starting up new ERP/CMMS systems a plus.
Technical Skills
• Experience with CMMS platforms, such as D365 EAM, SAP PM, Maximo or other CMMS platforms preferred
• Ability to work collaboratively with our clients to promote excellence in customer service.
• Ability to import data, create templates and export data as required is a plus
• Ability to generate reports and modify reports as needed.
• Strong communication and organizational skills.
• Excellent attention to detail and data integrity.
Non-Technical Skills
Results-oriented and able to navigate ambiguity, you set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational objectives. Respond promptly, take accountability, and manage tasks efficiently. Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges. Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment. Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness. Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset. Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by recognizing achievements and encouraging a healthy work-life balance. Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions. Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.
Initially working on a construction site and ultimately in a biotech manufacturing site in Sanford, NC.
Work is 100% on-site. This is not a hybrid or remote role.
• Requires up to 5% domestic travel
• Exposure to machinery, noise and physical hazards (with proper PPE)
The anticipated salary for this position will be $27.64 per/hour to $36.06 per/hour. 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-SH1
Director, Consumer Inflammation Marketing
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:
Let’s work together to make people smile in this vital role to shape the US launch of Rocatinlimab, an anti-OX40 human monoclonal antibody being investigated in partnership with Amgen for the treatment of atopic dermatitis, asthma, prurigo nodularis, and other inflammatory diseases.
The Director, Consumer Inflammation Marketing will lead and influence a cross-functional team to rapidly advance the pipeline of inflammation products through US commercial launch. They are responsible for the development and implementation of patient centric product strategy and promotional plans designed to achieve US sales objectives. Internally and in collaboration with alliance partners, they will work in cross functional matrix teams, manage external agencies and ensure the alignment of stakeholders to meet goals.
This is a pivotal launch role requiring extensive collaboration in an alliance setting, effective communication and planning skills, and innovative problem solving capabilities. It also requires broad experience in the consumer inflammatory marketing space, DTC and digital tactics, meaningful metrics and KPIs, and strong scientific acumen.
Essential Functions:
Leads the collaborative planning, alignment, approval and execution of patient/consumer marketing strategies and tactics designed to drive product support, demand and experience.
Works to create the US commercial plan for the pipeline of inflammation products with cross-functional and alliance partners. Effective execution of a full complement of strategically driven patient programs through positive, productive and collaborative relationships with alliance partners and external agency partners.
Drives alignment with strategic objectives and brand communications across the organization (Sales, Training, Marketing, business Insights & Analytics, Market Access, Patient Services, Legal, Medical, Public Affairs, Patient advocacy, etc.)
Ensures key promotional programs are managed effectively achieving KPIs on time and on budget
Facilitates a smooth running and compliant PRC process in concert with the PRC Team Members and partner agencies
Liaises with Sales Management and omnichannel marketing strategy development, training and HCP targeting
Utilizes Field Advisory Teams to collect input on tactics, performance, opportunities and challenges, as well as test materials
Ensures smooth and effective execution of all patient facing programs and materials, optimizing impact and efficiently driving positive user experience
Partners with business analytics team on market research projects to gain actionable insights and measure performance
Adheres to all company policies and legal, compliance and regulatory guidelines
Job Requirements:
Education
Bachelor’s degree
MBA preferred
Experience
Minimum 6 years Consumer/DTC pharmaceutical marketing in inflammatory disease (Dermatology or Allergy) in both traditional DTC and digital marketing tactics; multiple DTC brand experience a plus
Successful experience within a highly collaborative alliance environment
Outstanding leadership, project management and presentation skills
Experience in dermatology and/or allergy preferred
Recent launch experience a plus
Sales, Sales management, market research, patient advocacy or CPG experience a plus
Technical Skills
Proficient in MS Office Suite.
Non-Technical Skills
Highly motivated and great attention to detail. Strong ability to work under tight timelines and complex/changing situations. Excellent written and oral communication skills. Excellent interpersonal skills, innovative problem solving and intellectual curiosity. 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.
Physical demands:
Normal office environment with prolonged sitting and extensive computer work
Hybrid position requiring a minimum of 2 days/week in the Princeton Home Office
May require work outside of normal business hours due to West Coast based alliance partner and Internationally based Global team.
Working Conditions: Requires up to 40% domestic and international travel
The anticipated salary for this position will be $185,600 to $242,600. 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.
#LI-JC1
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.
Director HCP Inflammation Marketing
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:
Let’s work together to make people smile in this vital role to shape the US launch of Rocatinlimab, an anti-OX40 human monoclonal antibody being investigated in partnership with Amgen for the treatment of atopic dermatitis, asthma, prurigo nodularis, and other inflammatory diseases.
The Director, HCP Inflammation Marketing will lead and influence a cross-functional team to rapidly advance the pipeline of inflammation products. They are responsible for the development and implementation of product strategy and promotional plans designed to achieve US sales objectives. Internally and in collaboration with alliance partners, they will work in cross-functional matrix teams, manage external agencies and ensure the alignment of stakeholders to meet goals.
This is a pivotal launch role requiring extensive collaboration in an alliance setting, effective communication and planning skills, and innovative problem-solving capabilities. It also requires broad experience in the inflammation marketing space, launch leadership experience, biologics/ specialty pharmacy operations and strong scientific acumen.
Essential Functions:
Leads the collaborative planning, alignment, approval and execution of HCP marketing strategies and tactics designed to drive US performance.
Works to create the US commercial plan for the pipeline of inflammation products with cross-functional and alliance partners. Effective execution of a full complement of strategically driven HCP programs through positive, productive and collaborative relationships with alliance partners and external agency partners.
Drives alignment with strategic objectives and brand communications across the organization (Sales, Training, Marketing, business Insights & Analytics, Market Access, Patient Services, Legal, Medical, Supply, Public Affairs, etc.).
Ensures key promotional programs are managed effectively achieving KPIs on time and on budget.
Facilitates a smooth running and compliant PRC process in concert with the PRC team and partner agencies.
Liaises with Sales Management and contributes significantly to selling strategy development, training and targeting
Utilizes Field Advisory Teams to collect input on tactics, performance, opportunities and challenges, as well as test materials
Ensures smooth and effective execution of POA and rollout of training and promotional initiatives
Partners with business analytics team on market research projects to gain actionable insights and measure performance
Job Requirements:
Education
Bachelor’s degree required
MBA preferred
Experience
Minimum 6 years HCP pharmaceutical marketing in inflammatory disease (Dermatology or Allergy) in both traditional and digital marketing in the complex biologics space
Recent launch experience
Successful experience within a highly collaborative alliance environment
Outstanding leadership, project management and presentation skills
Experience in dermatology and/or allergy preferred
Sales, Sales management, managed care or market research experience a plus
Technical Skills
Proficient in MS Office Suite.
Non-Technical Skills
Highly motivated and great attention to detail. Strong ability to work under tight timelines and complex/changing situations. Excellent written and oral communication skills. Excellent interpersonal skills, innovative problem solving and intellectual curiosity. 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. Pure passion for the patients you serve and joy in the people you work with.
Physical Demands: Normal office environment with prolonged sitting and extensive computer work
Hybrid position requiring a minimum of 2 days/week in the Princeton Home Office
May require work outside of normal business hours due to West Coast based alliance partner and Internationally based Global team
Working Conditions: Requires up to 40% domestic and international travel
The anticipated salary for this position will be $185,800 to $242,600. 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.
Director HCP Inflammation Marketing
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:
Let’s work together to make people smile in this vital role to shape the US launch of Rocatinlimab, an anti-OX40 human monoclonal antibody being investigated in partnership with Amgen for the treatment of atopic dermatitis, asthma, prurigo nodularis, and other inflammatory diseases.
The Director, HCP Inflammation Marketing will lead and influence a cross-functional team to rapidly advance the pipeline of inflammation products. They are responsible for the development and implementation of product strategy and promotional plans designed to achieve US sales objectives. Internally and in collaboration with alliance partners, they will work in cross-functional matrix teams, manage external agencies and ensure the alignment of stakeholders to meet goals.
This is a pivotal launch role requiring extensive collaboration in an alliance setting, effective communication and planning skills, and innovative problem-solving capabilities. It also requires broad experience in the inflammation marketing space, launch leadership experience, biologics/ specialty pharmacy operations and strong scientific acumen.
Essential Functions:
Leads the collaborative planning, alignment, approval and execution of HCP marketing strategies and tactics designed to drive US performance.
Works to create the US commercial plan for the pipeline of inflammation products with cross-functional and alliance partners. Effective execution of a full complement of strategically driven HCP programs through positive, productive and collaborative relationships with alliance partners and external agency partners.
Drives alignment with strategic objectives and brand communications across the organization (Sales, Training, Marketing, business Insights & Analytics, Market Access, Patient Services, Legal, Medical, Supply, Public Affairs, etc.).
Ensures key promotional programs are managed effectively achieving KPIs on time and on budget.
Facilitates a smooth running and compliant PRC process in concert with the PRC team and partner agencies.
Liaises with Sales Management and contributes significantly to selling strategy development, training and targeting
Utilizes Field Advisory Teams to collect input on tactics, performance, opportunities and challenges, as well as test materials
Ensures smooth and effective execution of POA and rollout of training and promotional initiatives
Partners with business analytics team on market research projects to gain actionable insights and measure performance
Job Requirements:
Education
Bachelor’s degree required
MBA preferred
Experience
Minimum 6 years HCP pharmaceutical marketing in inflammatory disease (Dermatology or Allergy) in both traditional and digital marketing in the complex biologics space
Recent launch experience
Successful experience within a highly collaborative alliance environment
Outstanding leadership, project management and presentation skills
Experience in dermatology and/or allergy preferred
Sales, Sales management, managed care or market research experience a plus
Technical Skills
Proficient in MS Office Suite.
Non-Technical Skills
Highly motivated and great attention to detail. Strong ability to work under tight timelines and complex/changing situations. Excellent written and oral communication skills. Excellent interpersonal skills, innovative problem solving and intellectual curiosity. 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. Pure passion for the patients you serve and joy in the people you work with.
Physical Demands: Normal office environment with prolonged sitting and extensive computer work
Hybrid position requiring a minimum of 2 days/week in the Princeton Home Office
May require work outside of normal business hours due to West Coast based alliance partner and Internationally based Global team
Working Conditions: Requires up to 40% domestic and international travel
The anticipated salary for this position will be $185,800 to $242,600. 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.
Global Regulatory Affairs Compliance and Planning Manager
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 $135,000 to $145,000. 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
Head of Forecasting
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.
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