Director of Pharmacometrics- Clinical Pharmacology

Overview

Director of Pharmacometrics
- Clinical Pharmacology at Kyowa Kirin. Kyowa Kirin is a global specialty pharmaceutical company focused on four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. The company operates from Japan with North American headquarters in Princeton, NJ, and offices in California, North Carolina, and Mississauga, Ontario.

The Director of Pharmacometrics will lead a team of Pharmacometricians within the Global Development Organization (GDO) and Clinical Pharmacology (CP) function. The role balances direct project-related activities with coaching and development of team members in model-informed drug development (MIDD) strategies. The Director will support development of workflows and systems to deliver quantitative clinical pharmacology outputs and will help GDO CP members communicate MIDD strategies to project teams.

The Director will educate leadership across the GDO on the value of MIDD and quantitative clinical pharmacology, and will explore innovative collaborations with Kyowa Kirin organizations outside GDO (e.g., Regulatory Affairs and Medical Affairs) to expand MIDD usage throughout development and post-marketing spaces.

• 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 focus on developing Pharmacometrics Leads.
• Develop and maintain a network of external pharmacometrics experts to support advanced 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.

Education
PhD preferred with specialty training in Pharmacometrics; appropriate MS or Pharm

D also applicable.

Experience

• Minimum 10 years of pharmaceutical industry experience in pharmacometrics/quantitative clinical pharmacology.

• Ability to communicate and apply MIDD strategies to drug development.

• Understanding of pharmacometrics contributions to successful clinical development of small molecules, biologics, and alternative therapies.

• Experience using MIDD to support drug development decision making.

• Hands-on modeling and simulation experience in a regulated drug development environment; expert in the field.

• Experience in preparing strategic regulatory documents including reports, summary documents, and responses to information requests.

• Leadership of a team with diverse pharmacometrics backgrounds and skills.

• Experience developing pharmacometricians and communication skills.

Technical Skills
Proficient in MS Office; demonstrated proficiency with pharmacometric software tools for nonlinear mixed effects modeling, data manipulation, physiologically based pharmacology, and systems pharmacology modeling (e.g., Julia/Pumas, R, NONMEM).

The anticipated salary for this position will be $200,000 to $230,000. The actual salary offered may vary…