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Kyowa Kirin, Inc.- U.S. · 3 days ago

Director of Pharmacometrics- Clinical Pharmacology

Princeton, NJ

Full-time

Hybrid

Director/Executive

$200K/yr - $230K/yr

10+ years exp

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines. The Director of Pharmacometrics will lead a team of Pharmacometricians within the Global Development Organization and Clinical Pharmacology function, focusing on model informed drug development strategies and ensuring high-quality pharmacometrics deliverables.

Pharmaceuticals

Responsibilities

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

Qualification

PharmacometricsQuantitative clinical pharmacologyModel-Informed Drug DevelopmentLeadership in pharmacometricsRegulatory submissionsModelingSimulationPharmacometric software toolsMS Office SuiteCommunication skills

Required

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

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