Sr. Director, Pharmacometrics
About The Position
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 Senior Director of Pharmacometrics provides strategic and operational leadership to a team of Pharmacometricians within the Global Development Organization (GDO) and Clinical Pharmacology (CP) function. This role is accountable for advancing and executing model-informed drug development (MIDD) strategies across the portfolio, ensuring high-quality quantitative clinical pharmacology deliverables that support program decision-making and regulatory success. The Senior Director leads and mentors team members in project execution, professional development, and scientific excellence. This individual is responsible for ensuring that pharmacometric analyses and associated documentation are regulatory-ready and appropriately integrated into Common Technical Documents (CTDs) and other global submission materials. In addition, the Senior Director drives the continuous evolution of workflows, systems, and best practices to enhance efficiency, quality, and innovation in quantitative clinical pharmacology. The role partners closely with GDO and CP leadership to embed MIDD strategies across development programs, strengthening organizational understanding of their strategic value and impact. The Senior Director also collaborates cross-functionally, including with Regulatory Affairs and Medical Affairs—to expand the application of MIDD throughout development and into the post-marketing setting, fostering innovative, integrated approaches that maximize program success.
Requirements
- Ph.D. in Pharmacometrics, Clinical Pharmacology, Pharmaceutical Sciences, Biomedical Engineering, Applied Mathematics, Statistics, or a closely related quantitative discipline strongly preferred.
- Minimum 15 years of progressive pharmaceutical industry experience in pharmacometrics and/or quantitative clinical pharmacology, including leadership at the program or portfolio level.
- Demonstrated success developing and executing cross-portfolio Model-Informed Drug Development (MIDD) strategies that influence key development and regulatory decisions.
- Proven track record of building, mentoring, and leading high-performing pharmacometrics teams.
- Experience leading pharmacometric contributions across all stages of clinical development for small molecules, biologics, and novel therapeutic modalities.
- Proven ability to influence cross-functional teams and challenge organizational assumptions to improve drug development practices and decision quality.
- Solid 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
- Record of vendor management including contract negotiation, budget management, timely milestone delivery
- Ability to conduct hands-on modeling and simulation using appropriate quantitative tools in a regulated drug development environment, considered expert in field
- Extensive experience preparing and overseeing strategic regulatory documents, including clinical pharmacology reports, modeling summaries, briefing packages, CTD components, and responses to health authority inquiries
- Experience presenting and defending empirical and mechanistic models during regulatory interactions with global health authorities.
- Advanced expertise in population pharmacokinetic/pharmacodynamic (PK/PD) modeling, exposure–response analysis, clinical trial simulation, and quantitative systems pharmacology (QSP).
- Demonstrated proficiency with pharmacometrics software tools for non-linear mixed effects modeling, data manipulation, physiologically based pharmacology, and system
- Expert-level proficiency in industry-standard pharmacometrics software and programming environments, such as NONMEM, R/RStudio, Julia/Pumas, and related simulation and data manipulation tools.
- Solid understanding of regulatory expectations for pharmacometrics analyses and documentation in global submissions.
- Proficiency with MS Office Suite to effectively communicate technical findings to diverse audiences.
- Requires up to 10% domestic and international travel
Responsibilities
- Accountable for pharmacometrics deliverables of others to support 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 (including CTDs), and responses to health authority inquiries..
- Create future leaders through mentoring and support conflict resolution within teams
- Provide scientific and technical leadership to pharmacometrics staff, ensuring excellence in modeling methodologies, analytical rigor and effective communication at all organizational levels.
- Support clear and impactful communication of pharmacometric and clinical pharmacology results to diverse internal and external audiences.
- Advance Model-Informed Drug Development (MIDD) standards by incorporating best practices from the scientific community to continuously improve workflows, processes, and analytical rigor.
- Collaborate with GDO Clinical Pharmacology colleagues to challenge status quo, drive alignment and develop cross-functional partners to improve efficiency and innovation across drug development initiatives.
- 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.
Benefits
- 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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Executive
Education Level
Ph.D. or professional degree
