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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 Director, Clinical Quality Management serves as the central Risk-Based Quality Management (RBQM) Lead for Clinical Operations, responsible for enterprise-wide, proactive risk management across clinical trials. This role owns the end-to-end RBQM framework, including risk identification, assessment, mitigation, centralized monitoring, lessons learned, and maintenance of a clinical risk library, ensuring risks are managed consistently and intelligently across studies, programs, vendors, and regions. The role partners cross-functionally to embed risk-based decision-making into study design, execution, oversight, and continuous improvement, in alignment with ICH E6 (R3), GCP, and global regulatory expectations.

Essential Functions:

Risk-Based Quality Management (RBQM) Leadership
•    Lead the design, implementation, and continuous evolution of a holistic RBQM framework across Clinical Operations, aligned with ICH E6 (R3) and regulatory guidance.
•    Serve as the central RBQM authority ensuring consistent risk management approaches across trials, programs, regions, and vendors.
•    Integrate RBQM principles into study planning, execution, oversight, and close-out activities.
•    Provide expert oversight and guidance to study teams on study-level RBQM plans, ensuring alignment with enterprise risk strategy.

Central Risk Identification, Monitoring & Mitigation

•    Lead proactive, cross-study and cross-functional risk assessments to identify systemic, emerging, and study-specific risks.
•    Define, standardize, and maintain Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) across trials.
•    Oversee centralized risk monitoring and trending to enable early detection of critical risks.
•    Partner with study teams to develop and oversee risk mitigation, contingency, and escalation plans, ensuring inspection Lessons 

Learned & Risk Library Management (Core Ownership)

•    Establish and maintain a centralized Clinical Risk Library, capturing:
o    Known and emerging risks
o    Root causes
o    Mitigation strategies
o    Effectiveness of controls
•    Lead lessons learned activities across trials, audits, inspections, and CAPAs.
•    Ensure lessons learned are:
o    Systematically captured
o    Analyzed for trends
o    Fed back into RBQM planning, SOPs, training, and future studies
•    Drive organizational learning by translating lessons learned into preventive, forward-looking risk controls.readiness.

Quality Oversight & Regulatory Compliance

•    Ensure clinical trial conduct complies with GCP, regulatory requirements, and company SOPs.
•    Provide centralized quality oversight across trials, CROs, and vendors.
•    Support audit and inspection readiness activities, including:
o    Risk-based inspection preparation
o    Impact assessments
o    CAPA development and effectiveness checks

Vendor & CRO Risk Oversight

•    Design and implement risk-based oversight strategies for CROs and external vendors.
•    Monitor vendor performance using quality metrics and risk indicators.
•    Lead or support quality governance discussions with external partners.
•    Ensure vendor-related risks are integrated into the central risk library and lessons learned framework.

Data-Driven Quality & Continuous Improvement

•    Leverage data analytics and centralized monitoring tools to enable real-time risk detection and decision-making.
•    Generate enterprise-level risk trend reports and insights for senior leadership.
•    Continuously refine RBQM methodologies based on data, inspection outcomes, and lessons learned.
•    Champion a culture of proactive quality and continuous improvement across Clinical Operations.

Cross-Functional Collaboration & RBQM Expertise

•    Act as the RBQM Subject Matter Expert (SME) for Clinical Operations and Clinical Quality Compliance.
•    Provide RBQM training and coaching to study teams and cross-functional stakeholders.
•    Collaborate closely with Regulatory, Biostatistics, Data Science, QA, and Vendor Management teams to align risk strategies and metrics.
•    Participate as an observing member on assigned study teams to provide real-time quality and risk support.

SOP Management & Governance Support

•    Partner with Document Control and SOP Administration teams to ensure RBQM and lessons learned are reflected in SOPs, WIs, and templates.
•    Support governance activities, senior management reporting, and quality metrics standardization.
•    Recommend and support implementation of corrective and preventive actions to protect system, process, and data integrity.provide real-time quality and risk support.

Requirements:

Education
•    Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Public Health, or related field (required)
•    Advanced degree in Clinical Research, Quality Management, Regulatory Affairs, or Data Science (preferred)

Experience
•    10+ years of experience in Clinical Operations, Clinical Quality, RBQM, or RBM
•    Demonstrated experience leading enterprise or cross-study risk management frameworks
•    Strong background in audit/inspection readiness, CAPA management, and vendor oversight
•    Deep knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements

Technical Skills
•    Expertise with RBQM tools, centralized monitoring systems, and risk analytics
•    Experience defining and using KRIs, QTLs, and quality metrics
•    Familiarity with CTMS, eTMF, and data visualization tools (Spotfire, Tableau, Power BI)
•    Exposure to AI or predictive analytics for quality monitoring (preferred)

Working Conditions:

Requires up to 25% domestic and international travel. May involve working outside of regular business hours to accommodate global time zones and project deadlines.

The anticipated salary for this position will be $175,000 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 match
• 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 Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

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

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

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

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

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

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

Recruitment & Staffing Agencies

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

#LI-TT1 #Hybrid #Princeton

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

Summary:

The Associate Director, ERP Functional & Solution Architect, ICT role will be responsible for overseeing MS D365 Enterprise Resource Planning (ERP) within the organization. Crucial role in implementing ERP specific business process improvements and enhancements within the organization and ensuring the system's optimal performance and functionality. Perform the planning, design, configuration, customization, and implementation of MS D365/ERP modules and functionalities, ensuring seamless integration with existing systems, ensuring compliance with industry standards, security protocols, and regulatory requirements. The ERP Functional Architect, Associate Director, ICT role will also serve as a business process analyst aligned with enterprise (i.e., SCM, MFG, Quality) and Corporate Functions (i.e., Finance, HR, Legal, Compliance, Procurement) ensuring successful technical solution development and delivery.

Essential Functions:

The D365 ERP F&O Functional Architect is responsible for the end-to-end functional design, configuration, and optimization of Microsoft Dynamics 365 Finance & Operations to support business operations across Finance, Procurement, Supply Chain, Manufacturing, Quality, and related business functions. The architect will partner with business stakeholders, technical teams, and implementation partners to ensure that the solution is aligned with corporate strategy, compliant with GxP/GAMP 5 standards (where applicable), and scalable for future business growth.

1. Solution Architecture & Design
•    Lead the functional design and architecture of the D365 F&O solution across key modules (Finance, Supply Chain, Manufacturing, Procurement, Inventory, Quality, etc.).
•    Translate complex business requirements into clear, scalable, and compliant functional solutions.
•    Emphasizes proactive, holistic leadership in solution architecture.
•    Focuses on aligning solutions with business goals, value streams, and enterprise architecture governance.
•    Define data flows, integrations, and system interactions between D365 and other enterprise systems & interfaces (e.g., LIMS, MES, 3PL Partners, External Finance Systems, and Cloud systems).
•    Ensure alignment with Microsoft’s Dynamics 365 roadmap and best practices.

2. Implementation & Configuration
•    Perform and lead the setup, configuration, and deployment of D365 F&O modules. 
•    End to end management of project/solution management by using tools like Azure Boards for planning and tracking work, Azure Repos for code versioning, and Azure Pipelines for automating build and deployment. Perform all activities from initial user stories and tasks to code, testing, and deployment through integrations with tools like Lifecycle Services (LCS). 
•    Drive fit-gap analysis and functional documentation. Develop User/Functional Requirements, Functional/Technical Design, System/Business process architecture diagrams.
•    Collaborate with development/vendor/managed service teams to define functional specifications for enhancements, bug/fix, customizations, reports, and interfaces. Co-develop or individually develop code/configurations required and coordinate internal development and user acceptance testing of the solution.
•    Participate in system validation activities, including IQ/OQ/PQ documentation for regulated environments.

3. Governance & Compliance
•    Ensure the ERP system design complies with GAMP 5, SOX, and GxP regulatory requirements.
•    Develop and maintain master data governance, change management, and configuration control processes.
•    Support audits and inspections through proper documentation and traceability.
•    Develop current and future state roadmaps and architecture.
•    Assess and align system release plan with Microsoft Dynamics 365 roadmap

4. Stakeholder Collaboration
•    Partner with business process owners to define best practices, continuous improvement opportunities, and confirm desired solution to fix the support/bug-fix items raised. Support communities of practice and collaborative development methodology.
•    Work independently to perform required fix within the D365 framework. Test and confirm the developed fix with business process owners. 
•    Work closely with IT, OT, and cloud teams to ensure integrated digital architecture.
•    Provide subject matter expertise and training for internal business process owners and super users.

5. Project & Vendor Management
•    Support ERP implementation and upgrade projects through all phases — initiation, design, testing, go-live, and hypercare.
•    Manage and coordinate external implementation partners and vendors.
•    Define KPIs and monitor system performance, adoption, and ROI.

Requirements:

Education 

Bachelor’s degree or equivalent experience in computer science, information systems, engineering, supply chain, or related fields required. Microsoft D365 F&O Certification preferred.

Experience
•    8+ years of experience implementing or supporting Microsoft Dynamics AX / D365 F&O.
•    Proven expertise across multiple functional domains (Finance, Manufacturing, Supply Chain, Procurement).
•    Experience designing integrations between ERP and external systems (LIMS, MES, Payment interface with Bank, External Finance Systems, etc.).
•    Strong understanding of ERP data models, workflows, and reporting.
•    Strong understanding of functional and solution architecture of, and experience performing code and configuration updates within the following Dynamics 365 modules:
o    Finance: General ledger, Cash and bank management, Accounts payable, Accounts receivable. Budgeting, Fixed assets, Cost accounting, PR/PO process, Vendor Management, Cost Accounting and Management 
o    SCM: Inventory management, Master planning, Procurement and sourcing, Product information management, Production control, Warehouse management, Cost accounting, Cost management, Asset management, including scheduled maintenance and repair tasks 

Technical Skills
•    Proficient in MS Office Suite. Experience with technology delivery applications across solutions such as (ERP, Manufacturing Execution Systems, Finance Systems, Control Tower). 
•    Microsoft Certified: Dynamics 365: Finance and Operations Apps Solution Architect Expert certification preferred.
•    Experience with emerging technologies (AI/ML, cloud, etc.) as relevant to ERP.

Working Conditions:

Requires up to 10 % domestic and international travel

The anticipated salary for this position will be $165,000 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 match
• 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 Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

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

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

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

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

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

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

Recruitment & Staffing Agencies

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

#LI-TT1 #Hybrid #Princeton

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

Summary:

The Associate Director, Regulatory Affairs, Advertising and Promotion Compliance will independently review, approve, and monitor product advertising and promotional labeling material for an assigned product to ensure compliance with US regulatory requirements.  In addition, the associate director will be responsible for supporting preparation of FDA Form 2253 submissions and any requests for advisory comment submissions to FDA's Office of Prescription Drug Promotion (OPDP) as well as submissions to PAAB for promotional materials in Canada, as applicable.

Essential Functions:

•    The Associate Director is responsible for providing strategic and tactical regulatory support and guidance for assigned product and disease state communications as well as pipeline and non-promotional communications. 
•    Provides guidance and input for assigned development products reflective of promotional considerations, including assessment of potential labeling claims.
•    Serves as Promotional Review Committee (PRC) chair and as the primary regulatory reviewer of advertising, promotions, and other related materials for assigned product to ensure compliance with applicable FDA/Health Canada laws, regulations, and guidance.  
•    Works collaboratively with cross-functional partners, including Legal and Medical as part of PRC. Develops solutions to complex promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively identifying, escalating, and managing business risks.  
•    Serves as the regulatory reviewer for the Medical Review Process (MRC) for assigned product(s).
•    Provides direction and works collaboratively to ensure that changes in US Prescribing Information and Canadian Product Monograph are reflected in current promotions and advertising
•    Continually assesses the advertising and promotion related
process to enhance efficiencies and compliance. 
•    Collaborates in cross-functional efforts to develop, update, and implement policies, procedures and guidelines related to Regulatory Advertising and Promotion Compliance.
•    Primary liaison with Office of Prescription Drug Promotion (OPDP) regarding advertising and promotion for assigned products.
•    Monitors US and Canadian regulatory promotional environment and stays abreast of all relevant regulatory and industry changes and updates related to FDA and Health Canada guidance, warning letters, enforcement actions and regulations; and communicate to appropriate internal and external personnel in a timely manner, highlighting the implications of the changes
•    Ensures the maintenance of paper and electronic records of all submissions and communications with OPDP, and any supporting documentation
•    Provide relevant regulatory compliance training to staff and cross-functional partners from a regulatory perspective.

Requirements:

Education
Bachelor’s degree in life science or closely related discipline. Advance degree preferred (Pharm.D., Phd, M.S, JD)

Experience
•    Minimum seven (7) years of progressive experience in the pharmaceutical or biotechnology industry, specifically in Regulatory Affairs with a focus on Advertising and Promotion (Ad/Promo).
•    Proven track record as the primary regulatory reviewer for promotional and non-promotional materials across various therapeutic areas, ensuring compliance with FDA regulations, industry guidelines (e.g., OPDP, PhRMA), and internal policies.
•    Strong experience in leading and managing Regulatory review processes within cross-functional Medical, Legal, and Regulatory (MLR) teams for both consumer and professional marketing materials.
•    Familiarity with launch planning, including pre-approval communications, disease awareness campaigns, and launch materials. 
•    Experience with training Commercial and cross-functional teams on promotional compliance principles, regulatory changes, and industry best practices.
•    Preferred, but not required, experience with reviewing promotional and non-promotional communications in Canada to be compliant with Health Canada regulations.

Technical Skills
•    Thorough knowledge of applicable regulations, guidance, and industry standards related to advertising and promotional communications about prescription drugs, devices (if applicable), and investigational treatments in the US
•    Understanding of clinical study design and statistical analyses in assessment of promotional claims
•    Excellent written, verbal, and presentation skills, with the ability to communicate effectively across all levels of the organization.
•    Solid proficiency using Microsoft Office Suite including Word, Excel, and Power Point for documentation, analysis, and presentations.
•    Experience with Veeva, SharePoint and Box

Working Conditions:

Requires up to 10% domestic and international travel

The anticipated salary for this position will be $____ to $____.  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 match
• 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 Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

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

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

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

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

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

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

Recruitment & Staffing Agencies

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

#LI-TT1 #Hybrid #Princeton

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

Summary:

The Associate Director, Site Budget Management provides strategic and operational leadership across assigned segments of Kyowa Kirin’s global clinical study portfolio. This role bridges study-level execution and enterprise strategy by overseeing budget governance, forecasting methodology, financial risk management, and process optimization initiatives.

The Associate Director drives consistency in budget development, negotiation parameters, and payment oversight while contributing to short and mid-range portfolio planning. This position ensures financial integrity, scalability, and alignment with global FMV standards across all new and ongoing studies within scope.

Essential Functions:

Portfolio Oversight and Financial Planning
•    Provide oversight across multiple global studies within assigned therapeutic areas or portfolio segments.
•    Partner with the Director to support long range financial planning across the clinical pipeline.
•    Review and validate study-level forecasts to ensure portfolio alignment.
•    Identify cross-study cost trends, variance drivers, and financial risk indicators.
•    Support accrual accuracy and forecast predictability.
 
Global Budget Governance and FMV Oversight
•    Ensure consistent application of FMV methodology across assigned studies.
•    Validate high, mid, and low negotiation parameters.
•    Review CRO-developed budgets for compliance and alignment to governance standards.
•    Support regional alignment including US, EU, and Japan point system methodologies.
•    Maintain audit-ready documentation and financial traceability.
 
 Budget Development and Negotiation Leadership
•    Oversee study-level budget build, review, and approval processes.
•    Provide negotiation strategy guidance to Senior Managers and CRO analysts.
•    Escalate deviations outside approved financial thresholds.
•    Ensure budget alignment with protocol scope and operational effort.
•    Review amendment-related financial impacts.
 
Process Optimization and Standardization
•    Identify opportunities to improve global budget workflows.
•    Standardize templates, parameter frameworks, and tracking tools.
•    Reduce negotiation cycle times through structured governance.
•    Contribute to automation and systems integration initiatives.
•    Develop KPIs to measure performance, cycle time, and cost containment.
 
 Site Payment and Vendor Oversight
•    Provide financial oversight of site payment execution across assigned portfolio.
•    Monitor vendor and CRO payment performance.
•    Review reconciliation reporting and identify discrepancies.
•    Serve as escalation point for complex payment-related issues.
•    Ensure payment schedules align with approved budgets and contractual terms.
 
 Financial Analytics and Executive Reporting
•    Prepare consolidated financial dashboards for assigned portfolio segment.
•    Provide variance analysis and risk summaries.
•    Support executive reporting with clear financial narratives.
•    Conduct scenario modeling to evaluate financial impact of amendments, enrollment changes, or country mix adjustments.
 
 Leadership and Organizational Support
•    Directly manage Site Budget Managers and Senior Managers as assigned.
•    Provide strategic oversight to CRO budget analysts within outsourced model.
•    Mentor team members on forecasting discipline and governance expectations.
•    Support resource demand planning based on study complexity and portfolio growth.

Requirements:

Education
Bachelor’s degree in finance, Business Administration, Accounting, Life Sciences, or related discipline required.
Advanced degree or professional certification preferred

Experience
•    Minimum seven (7) years of experience in clinical trial budgeting, site financial management, or global clinical business operations.
•    Demonstrated experience managing global site budgets.
•    Experience within an outsourced CRO operating model.
•    Experience supporting portfolio forecasting and financial analytics.
•    Experience leading or mentoring budget professionals.
•    Working knowledge of Japan FMV methodology preferred.

Technical Skills
•    Advanced Excel and financial modeling capability.
•    Expertise in FMV benchmarking tools.
•    Experience with GrantPlan or equivalent systems.
•    Familiarity with CTMS, reporting platforms, and payment tracking systems.
•    Strong analytical and risk assessment capability.

Core Competencies
•    Strategic thinking with operational execution strength
•    Financial governance discipline
•    Process improvement mindset
•    Executive communication capability
•    Risk identification and mitigation
•    Structured decision making
•    Cross-functional collaboration
•    High integrity and compliance orientation

Working Conditions:

•    Requires up to 10%-15% domestic and international travel
•    Availability to support global teams across multiple time zones, including periodic late evening calls.

The anticipated salary for this position will be $175,000 to $205,000.  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 match
• 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 Services
• Long Term Incentive Program (subject to job level and performance)
• 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 #Remote #Princeton

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

Summary:

The Veeva Vault Architect serves as the technical and strategic leader for designing, implementing and optimizing Veeva Vault solutions across the global organization.  This role ensures that all Vault applications align with business objectives, regulatory requirements, and enterprise architecture standards.  The architect collaborates closely with business stakeholders, IT teams and implementation / support partners to deliver scalable, compliant and high performing Vault-based solutions.

Essential Functions:

Solution Architecture & Design
•    Develop end to end architecture for Veeva Vault applications (e.g., Quality, RIM, Medical, Commercial).
•    Interpret business requirements into scalable, secure and compliant Vault configurations.
•    Define data models, object structures, workflows, lifecycle states and security models.
•    Establish integration patterns between Vault and other enterprise systems (ERP, LMS, MDM, LIMS, etc.).
•    Create architectural standards, design documents and technical specifications.

Platform Leadership
•    Serve as the subject matter expert for Veeva Vault capabilities, limitations and best practices.
•    Guide configuration teams on Vault objects, metadata, workflows and automation.
•    Familiarity with domain level configuration and best practices.
•    Evaluate new Vault features and releases, advising on adoption and impact.
•    Ensure alignment with GxP, 21 CFR Part 11, Annex 11, and other regulatory frameworks.

Implementation & Delivery
•    Lead technical workstreams during Vault implementations, migrations and enhancements.
•    Oversee data migration strategies, mapping, cleansing and validation.
•    Support test planning, execution, and defect resolution for configuration and integrations.
•    Partner with project managers to ensure delivery timelines and quality standards are met.

Integration & Data Management
•    Architect and oversee integrations using native Veeva Vault Integrations, Veeva APIs, Vault Loader and middleware tools across both Vault and other applications.
•    Ensure adherence to data governance, master data strategies and cross system data flows.
•    Ensure data integrity, auditability, and traceability across the Vault ecosystem.

Stakeholder Collaboration
•    Work with business process owners to understand needs and translate them into technical solutions.
•    Collaborate with QA/SA, Compliance, Data Privacy and Validation teams to ensure system readiness.
•    Provide technical guidance to internal teams and external implementation partners.

Operational Excellence
•    Establish monitoring, performance optimization and support frameworks.
•    Develop documentation, SOPs and knowledge transfer materials.
•    Support ongoing enhancements, change requests and continuous improvement initiatives.

Requirements:

Education

Bachelor’s degree or equivalent experience in computer science, information systems, engineering or related fields required. Veeva Vault certification(s) preferred.

Technical Skills
•    8+ years of experience in the configuration, implementation, support and operations of Veeva Vault-based solutions.
•    Proven expertise across multiple functional domains (Quality, Regulatory, Medical, Commercial and/or Clinical).
•    Hands-on experience with Veeva APIs, integration patterns and data migration tools.
•    Knowledge of GxP compliance, validation practices and regulated system requirements.
•    Experience with large-scale, global implementations.
•    Experience with middleware platforms (e.g., MuleSoft, Informatica), Master Data Management concepts and solutions preferred.

Working Conditions:

Requires up to 10 % domestic and international travel.

Willingness to work in a global environment with the ability to adapt to diverse cultural norms, including different communication styles, time zones, holiday schedules, and management approaches.

The anticipated salary for this position will be $185,000 to $200,000.  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 match
• 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 Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

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

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

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

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

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

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

Recruitment & Staffing Agencies

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

#LI-TT1 #Hybrid #Princeton

Kyowa Kirin is a global specialty pharmaceutical company committed to improving the lives of patients. Kyowa Kirin, Inc., the U.S. operating entity, is expanding its North American footprint by building its first U.S. manufacturing facility in Sanford, North Carolina (“Sanford”), a greenfield site currently progressing through the construction phase. As the site moves toward start‑up and future operations, we are seeking a full‑time, embedded attorney to support this critical initiative as it scales from build‑out to steady‑state operations.

Summary of Job:

The Manufacturing Counsel will be a member of the U.S. Kyowa Kirin Legal Department and serve as the primary legal business partner supporting the Sanford manufacturing site, with a focus on contracting and transactional support, while acting as the first point of legal contact for site leadership on regulatory, Human Resources, and operational matters.

This role will provide day‑to‑day legal support—in close collaboration with Legal, Compliance, Quality, and other internal subject‑matter experts—across Sanford‑related contracting and selected regulatory and compliance matters, including activities related to planning, construction, qualification, validation, regulatory submissions, and manufacturing operations.

As an individual contributor, the Manufacturing Counsel will operate as a trusted legal advisor, applying sound judgment, practical risk assessment, and a collaborative, solutions‑oriented approach in a fast‑paced, scaling manufacturing environment.

Reporting relationship:

Senior Director, Senior Corporate Counsel (Princeton, NJ), with dotted-line reporting relationship to the Vice President of Manufacturing (Sanford, NC).

Essential Functions:

Contracting & Transactional Support (primary responsibility)
• Utilize the Legal Department’s contract management system to manage the contracting process for Sanford-related agreements, including review, negotiation, approval, and execution.
• Partner with Sanford stakeholders to support the drafting and negotiation of manufacturing, construction, consulting, equipment, supply, and operations related agreements.
• Prepare guidance and training materials to support the efficient and compliant use of the Legal Department’s contract management system.
• Coordinate the work of paralegals and outside counsel supporting Sanford matters, as needed.

Regulatory & Human Resources Support
• Provide practical legal guidance on laws and regulations applicable to pharmaceutical manufacturing operations, including the Food, Drug, and Cosmetic Act. Partner with Princeton-based Legal colleagues and outside counsel, as needed, to address more complex or significant legal matters affecting Sanford operations.
• Provide legal support to Human Resources on Sanford-related employment and employee relations matters, in coordination with internal employment counsel and external counsel as appropriate.
• Work closely with colleagues from Legal and Compliance to provide consistent and efficient guidance in accordance with Kyowa Kirin’s healthcare compliance policies and related laws and regulations.
• Conduct legal research and draft memoranda / provide counsel in response to Sanford-related legal and regulatory inquiries.

Site Leadership & Strategic Cross-Functional Support
• Serve as a member of the Sanford site Senior Leadership Team and an embedded legal advisor to Sanford business partners by applying sound judgment, practical risk assessment, and a solutions‑oriented approach in a fast‑paced manufacturing and site‑startup environment.
• Engage regularly with Sanford site leadership and cross‑functional stakeholders to support alignment on contracting priorities, legal risk considerations, and compliance expectations.
• Collaborate with internal functions to support cross‑functional and cross‑border Sanford initiatives.
• Support Sanford‑related projects and initiatives that require coordination across functions or regions to ensure alignment with Kyowa Kirin policies and Legal Department practices.
• Develop strong working relationships across the organization and operate in alignment with Kyowa Kirin’s global values: Commitment to Life; Innovation; Integrity; and Teamwork / Wa.

Job Requirements:

Education
• BA/BS required.
• Juris Doctorate degree from Accredited Law School is required.
• Admission in good standing to at least one U.S. state bar; eligibility for North Carolina in-house registration required.

Experience
• 4–8 years of legal experience, preferably including contracting and legal support for manufacturing, construction, or operations in a regulated industry. Life science experience preferred but not required.
• Law firm experience required. In-house experience is a plus.
• Experience with cross-functional teams (including ex-US) and demonstrated ability to collaborate effectively with others to address complex legal, compliance, and operational issues is a plus.
• Experience in drafting and negotiating contracts such as master services agreements, statements of work, confidentiality agreements, consulting agreements, master purchase agreements, supply agreements, quality/technical agreements, and other corporate pharmaceutical-related and/or manufacturing-related agreements is required.
• Experience using contracting management systems (e.g., intake, workflow, approvals, and execution) is a plus.
• Must understand contract law and have effective communication and negotiation skills and the ability to influence and work collaboratively at all levels and across functions.
• Demonstrated understanding of pharmaceutical manufacturing operations and the related regulatory environment is a plus.
• Foundational understanding of employment law or counsel human resources functions is a plus.
• Experience supporting a start‑up, greenfield, or rapidly scaling operational environment is a plus.

Technical Skills
Advanced proficiency in MS Office Suite (Word, Excel, Outlook).

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.

Comfortable working onsite in a manufacturing and construction environment and engaging directly with operational stakeholders.

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.

Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain.

Physical Demands: The role will initially involve work in an office setting and on an active construction site in Sanford, North Carolina, with a planned transition in 2027 to the fully operational Sanford manufacturing facility.

Working Conditions: Requires up to 10% domestic and limited international travel

 

The anticipated salary for this position will be $227,300 to $270,000.  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
• 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 Incentive Program (subject to job level and performance)
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

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

 

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

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

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

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

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

Recruitment & Staffing Agencies

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

#LI-JC1

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to 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 Director of Pharmacometrics will lead a team of Pharmacometricians within the Global Development Organization (GDO) and Clinical Pharmacology (CP) function. The role is intended to have a balance of direct project related activities and to support team members in the development and execution of model informed drug development (MIDD) strategies. The Director of Pharmacometrics will support continued development of appropriate workflows and systems to provide quantitative clinical pharmacology deliverables. The Director of Pharmacometrics will help develop all GDO CP members on communication of MIDD strategies and approaches to project teams. The Director of Pharmacometrics will serve to communicate with and educate leadership across the GDO organization, including those in other GDO Functions, on the value of MIDD and quantitative clinical pharmacology strategies. The Director of Pharmacometrics will also look for innovative ways to work with Kyowa Kirin organizations outside of GDO, including but not limited to Regulatory Affairs and Medical Affairs, to increase MIDD strategies throughout development and in post-marketing space.

Essential Functions:

•    Accountable for pharmacometrics deliverables supporting project teams, ensuring scientific quality, timeliness, and impact; identify and drive opportunities to advance quantitative clinical pharmacology across the organization.
•    Guide pharmacometrics strategy and ensure high-quality preparation of pharmacometric components for scientific reports, regulatory submissions, and responses to health authority inquiries.
•    Provide scientific and technical leadership to pharmacometrics staff, ensuring excellence in modeling approaches and effective communication at all organizational levels.
•    Support clear and impactful communication of pharmacometric and clinical pharmacology results to diverse internal and external audiences.
•    Collaborate with GDO Clinical Pharmacology colleagues and cross-functional partners to improve efficiency, alignment, and innovation across drug development initiatives.
•    Advance Model-Informed Drug Development (MIDD) standards by incorporating best practices from the scientific community to continuously improve workflows, processes, and analytical rigor.
•    Establish and implement workflows, tools, and training programs, leveraging internal and external resources to strengthen pharmacometrics capabilities within GDO Clinical Pharmacology, with particular focus on developing Pharmacometrics Leads.
•    Develop and maintain a network of preferred external pharmacometrics experts to support advanced or specialized analyses as needed.
•    Promote scientific visibility through conference presentations and peer-reviewed publications, ensuring dissemination of insights and research outcomes to the broader scientific community.

Requirements:

Education
PhD preferred with specialty training in Pharmacometrics, appropriate MS or PharmD also applicable

Experience
•    Minimum 10 years of pharmaceutical industry experience gained in pharmacometrics / quantitative clinical pharmacology is required. 
•    The understanding and ability to communicate and apply MIDD strategies to drug development. 
•    Understanding of pharmacometrics contributions for successful clinical development of small molecules, biologics, and alternative therapies.
•    Experience in the successful use of MIDD to support drug development decision making
•    Ability to conduct hands-on modeling and simulation using appropriate quantitative tools in a regulated drug development environment, considered expert in field 
•    Experience in the preparation of strategic regulatory documents including reports, summary documents, and response to information requests.
•    Leadership of a team with various backgrounds and skills in pharmacometrics.
•    Experience of developing individuals pharmacometric and communication skills and talents  

Technical Skills
Proficient in MS Office Suite.
Demonstrated proficiency with pharmacometric software tools for non-linear mixed effects modeling, data manipulation, physiologically based pharmacology, and systems pharmacology modeling, such as: Julia/Pumas app, R-studio, NONMEM.

The anticipated salary for this position will be $230,000 to $250,000.  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 match
• Discretionary Profit Share
• 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 Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

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

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

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

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

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

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

Recruitment & Staffing Agencies

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

#LI-TT1 #Hybrid #Princeton

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

Summary of Job:

The NA Head of Medical Field Teams is a senior Medical Affairs leadership role responsible for the strategic leadership, oversight, and performance of the North America Field Medical organization. This role plays a key part in building and evolving the North America Field Medical function, including shaping the operating model, core processes, governance, and standards of excellence for MSL and HEOR field activities as the organization continues to grow.

The role oversees several MSL teams across different therapeutic areas, as well as a Medical Value Outcome Liaison (MVOL)  team, ensuring high quality, compliant scientific and health economic exchange aligned with regional and global Medical Affairs strategy.

The NA Head of Medical Field Teams is accountable for defining the field medical and HEOR engagement vision, operating model, and standards of excellence across therapeutic areas, while enabling strong execution, insight generation, and cross-functional collaboration. The role partners closely with Therapeutic Area leadership, HEOR leadership, Medical Affairs Operations & Excellence, Scientific Communications, and Global Medical Affairs to ensure integrated scientific and value-based engagement across the product lifecycle and is responsible for effectively communicating the value of Field Medical and Medical Value and Outcomes Liaisons (MVOL) team to senior leadership and other stakeholders through advanced analytics and reporting of outcomes and impact.

Essential Functions:

Field Medical & HEOR Strategy and Leadership

• Define and own the North America Field Medical and Medical Value Outcome Liaison (MVOL) Field strategy across multiple therapeutic areas, aligned with regional and global Medical Affairs objectives.
• Provide strategic leadership and direction to several TA MSL teams and Medical Value Outcome Liaison (MVOL) team, ensuring clear role differentiation while maintaining consistency in standards, expectations, and ways of working.
• Translate medical and HEOR strategy into field engagement models, priorities, and annual plans across therapeutic areas and assets.
• Serve as the senior field medical and Medical Value Outcome Liaison (MVOL) voice within North America Medical Affairs leadership forums.

People Leadership & Talent Development

• Directly lead and develop MSL and Medical Value Outcome Liaison (MVOL) people managers across therapeutic areas.
• Build a high-performing, patient-centric Field Medical and Medical Value Outcome Liaison (MVOL) organization through coaching, performance management, and professional development.
• Oversee hiring, onboarding, training, and succession planning for MSL and Medical Value Outcome Liaison (MVOL) teams.
• Foster a culture of scientific excellence, value-based thinking, compliance, collaboration, and continuous improvement.

Scientific, HEOR & External Engagement Excellence

• Ensure high quality, non-promotional scientific and health economic exchange with healthcare professionals, payers, decision makers, and other external stakeholders.
• Oversee field medical and HEOR engagement strategies, ensuring interactions are compliant, scientifically rigorous, and tailored to stakeholder needs.
• Guide MSL and Medical Value Outcome Liaison (MVOL) involvement in advisory boards, payer engagements, investigator meetings, congresses, and insight generation activities.

Insights Generation & Strategic Impact

• Provides strategic leadership and direction to the data innovation strategy utilizing systems and analytics to establish and oversee robust processes for collection, synthesis, and communication of scientific, clinical, and HEOR field-generated insights.
• Ensure insights inform medical strategy, evidence generation, value messaging, scientific communications, and development planning.
• Partner with Therapeutic Area Heads, HEOR leadership, and Asset Leads to translate insights into strategic actions.

Cross-Functional & Matrix Collaboration

• Partner closely with Therapeutic Area Heads, Regional Asset Leads, HEOR leadership, and Scientific Communications to ensure alignment between field execution and medical and value strategies.
• Collaborate with Medical Affairs Operations & Excellence on field medical and HEOR planning, resourcing, KPIs, and operational excellence.
• Work in close partnership with Clinical Development, Regulatory, Legal, and Compliance to support integrated and compliant execution.
• Serve as a key liaison between North America Field Medical/ Medical Value Outcome Liaison (MVOL) teams and Global Medical Affairs and Global HEOR leadership.

Governance, Compliance & Quality

• Ensure all MSL and Medical Value Outcome Liaison (MVOL) activities comply with internal SOPs, Medical Affairs governance, and external regulatory and industry standards.
• Oversee training and adherence to compliance requirements related to scientific exchange, health economic discussions, and non-promotional engagement.
• Identify and escalate scientific, compliance, or reputational risks related to field medical or Medical Value Outcome Liaison (MVOL) activities.

Key Interfaces

• Head of North America Medical Affairs
• Regional Therapeutic Area Heads
• Regional Asset Medical Leads
• Medical Affairs Operations & Excellence
• Scientific Communications Leadership
• Global HEOR, and Global Medical Affairs
• Clinical Development, Regulatory, Legal, and Compliance partners

Decision‑Making Authority

• Accountable for North America Field Medical and HEOR Field strategy, structure, and performance across therapeutic areas.
• Authority to define field engagement models, priorities, and resource allocation within approved plans.
• Input into Medical Affairs resourcing, organizational design, and capability development decisions.
• Escalation authority for field‑related scientific, HEOR, compliance, or operational risks.

Subordinates: MSL Directors

Job Requirements:

Education

Bachelor’s degree in life science, nursing or closely related discipline.  A doctorate level degree (e.g. MD, PharmD, PhD) in life sciences with relevant experience is highly preferred.

 Experience

• Minimum 15 years of progressive experience in Medical Affairs, including significant leadership of Field Medical (MSL) organizations within the pharmaceutical or biotechnology industry
• Demonstrated success leading large, multi-therapeutic area Field Medical teams, including direct oversight of MSL leaders and HEOR/MVOL functions
• Proven track record of defining and executing Field Medical and HEOR strategies aligned with regional and global Medical Affairs objectives
• Extensive experience engaging with key external stakeholders, including healthcare professionals, payers, and decision-makers, through compliant scientific and health economic exchange
• Strong background in building and scaling high-performing teams, including organizational design, talent development, and succession planning
• Experience operating within complex, matrixed organizations with demonstrated ability to influence cross-functional stakeholders and drive strategic alignment across Medical Affairs, Clinical, Regulatory, and Commercial partners

 Technical Skills

• Proven expertise in leading Field Medical organizations, including MSL and HEOR/MVOL teams, across multiple therapeutic areas
• Strong command of Medical Affairs strategy, including field engagement models, insight generation, and evidence-based scientific exchange
• Advanced knowledge of health economics, outcomes research (HEOR), and value-based healthcare principles
• Ability to translate medical and HEOR strategies into operational plans, KPIs, and measurable field execution frameworks
• Experience with data analytics, insight platforms, and systems to capture, synthesize, and operationalize field-generated insights Deep understanding of compliance frameworks, including FDA regulations, industry guidelines, and non-promotional engagement standards
• Exceptional cross-functional leadership and matrix collaboration skills across Clinical Development, Regulatory, Legal, and Commercial interfaces
• Proficient in MS Office Suite and Veeva.

Non-Technical Skills 

Strong management skills with demonstrated ability to plan for resourcing needs, set goals and objectives, establish and recalibrate priorities, provide feedback and appraise work. Ability to regularly assess individual’s skills, talents and career interests to ensure talent development. 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. 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. Ability to drive or fly to meetings.

Working Conditions: Requires up to 50% domestic and international travel, including some weekend commitments.

 

The anticipated salary for this position will be $256,800 to $332,300.  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 match
• 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 Services
• Long Term Incentive Program (subject to job level and performance)
• 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

#LI-Remote

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

Summary:

The Manager, ICT Delivery plays a critical role in delivery of complex technology projects and IT services. They combine strategic planning with tactical execution to align team output with broader organizational goals, managing everything from initial scoping to final deployment and post-launch support.  They ensure that digital initiatives are executed efficiently, securely and in alignment with GxP standards. They exhibit strong delivery leadership with a deep appreciation for the complexities of the pharmaceutical environment.

Essential Functions:

•    Participate in project planning, execution, risk management, and quality assurance across multiple concurrent initiatives.

•    Ensure solutions meet regulatory and data privacy requirements, including GxP, 21 CFR Part 11, HIPPA, GDPR and data integrity standards.

•    Apply and follow appropriate delivery methodologies (Agile, Waterfall, hybrid) based on project needs and compliance considerations.

•    Collaborate with business, technical teams and vendors to ensure accurate translation of business requirements into technical solutions.

•    Assume accountability throughout all phases of system development lifecycle from ideation and planning through production support and troubleshooting.

Additional activities may include, but are not limited to:
•    IT Project Oversight - Review project timelines, milestones, risks and budget to ensure delivery stays on track.
•    Stakeholder Communication & Alignment - Manage expectations, clarify priorities and drive compromise between business needs and technical constraints.
•    SDLC Compliance – Ensure all system changes follow appropriate lifecycle processes; review documentation for accuracy, completeness, and audit readiness.
•    Issue Resolution & Operational Support – Assist in the triage of issues / incidents that impact production systems or project timelines.

Requirements:

Education
Bachelor’s degree or equivalent experience in computer science, information systems, engineering or related fields required

Experience
At least 5 years’ experience delivering IT projects within a regulated industry, ideally pharmaceuticals or life sciences; Familiarity with multiple functional domains (e.g. Quality, Regulatory, Medical, Commercial and/or Clinical); Knowledge of GxP compliance, validation practices and regulated system requirements;  Experience with large-scale, global implementations; Experience with enterprise technologies such as Veeva Vault, Salesforce.com, Microsoft Dynamics

Technical Skills
Proficient in MS Office Suite.

Working Conditions:

Requires up to 10% domestic and international travel

The anticipated salary for this position will be $121,000 to $156,800.  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 match
• 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 Services
• Long Term Incentive Program (subject to job level and performance)
• 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