Associate Director Translational Pharmacokinetics and Pharmacokinetic/Pharmacodynamic

Associate Director

The Associate Director role involves supporting PK and PK/PD requirements for early-stage drug discovery and IND projects. Responsibilities include providing input and oversight for preclinical in vivo studies, coordinating with and influencing scientific teams conducting these studies, managing nonclinical PK studies, analyzing and presenting PK/PD data to project teams and senior management, and preparing summary reports for regulatory submissions.

Work Location: Tarrytown, NY

Hybrid: 4 days per week on site

Discover your role:

• Serving as a subject matter expert on Preclinical PK/PD within Discovery-stage project teams and guiding the design of preclinical PK/pharmacology studies.
• Collaborating with various internal groups such as Therapeutic Proteins, Therapeutic Function Areas, Assay Development, Precision Medicine, Preclinical Operations, and PPK/PD management to develop and execute PK strategies for projects.
• Effectively communicating project team queries, expectations, and timelines to management.
• Conducting and reporting PK/PD analyses based on data from preclinical studies.
• Working closely with Toxicology, Pathology, Clinical Pharmacology, and Quantitative Pharmacology teams within the Drug Safety and Pharmacometrics department to deliver data and regulatory documents supporting project progression.
• Maintaining current knowledge of scientific literature, regulatory guidance, and best practices related to PK/PD.

This role requires:

• PhD in Pharmacology, Pharmacokinetics, Biology/Molecular Biology, or Biochemistry with more than 8 to 10 years of relevant experience in biotech or pharma.
• Deep theoretical and applied understanding of PK and PD to interpret the pharmacology and biology of therapeutic proteins. Experience with other modalities such as siRNA, CRISPR-based therapeutics, and cell therapies is highly beneficial.
• Proven ability to plan, coordinate, lead PK and/or PK/PD studies, and analyze related data.
• Familiarity with PK/PD (e.g., WinNonLin), data visualization and AI software and experience writing scientific reports and regulatory summaries.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience.