Director of Pharmacometrics- Clinical Pharmacology

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 ph