Associate Director Preclinical & Translational Pharmacokinetics/Pharmacodynamics

Regeneron Pharmaceuticals•Tarrytown, GA

8d•$176,100 - $287,300•Hybrid

About The Position

The Associate Director role involves supporting Pharmacokinetics (PK) and Pharmacokinetics/Pharmacodynamics (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 Pharmacokinetics studies, analyzing and presenting PK/PD data to project teams and senior management, and preparing summary reports for regulatory submissions.

Requirements

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.
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.

Nice To Haves

Experience with other modalities such as siRNA, CRISPR-based therapeutics, and cell therapies is highly beneficial.

Responsibilities

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.