Associate Director, Preclinical and Translational PK/PD
Regeneron
September 02, 2026
Remote friendly (Tarrytown, NY)
United States
Clinical Research and Development
The Associate Director role involves supporting PK and PK/PD requirements for early-stage drug discovery and IND projects.
Responsibilities:
- Provide input and oversight for preclinical in vivo studies.
- Coordinate with and influence scientific teams conducting preclinical studies.
- Manage nonclinical PK studies.
- Analyze and present PK/PD data to project teams and senior management.
- Prepare summary reports for regulatory submissions.
- Serve as a subject matter expert on Preclinical PK/PD within Discovery-stage project teams; guide design of preclinical PK/pharmacology studies.
- Collaborate with internal groups (Therapeutic Proteins, Therapeutic Function Areas, Assay Development, Precision Medicine, Preclinical Operations, PPK/PD management) to develop and execute PK strategies.
- Communicate project team queries, expectations, and timelines to management.
- Conduct and report PK/PD analyses from preclinical study data.
- Work with Toxicology, Pathology, Clinical Pharmacology, and Quantitative Pharmacology (Drug Safety and Pharmacometrics) to deliver data and regulatory documents.
- Maintain knowledge of scientific literature, regulatory guidance, and PK/PD best practices.
Qualifications:
- PhD in Pharmacology, Pharmacokinetics, Biology/Molecular Biology, or Biochemistry with 8–10+ years of biotech/pharma experience.
- Deep theoretical/applied understanding of PK/PD to interpret therapeutic protein pharmacology/biology; experience with siRNA, CRISPR-based therapeutics, and/or cell therapies preferred.
- Proven ability to plan, coordinate, lead PK and/or PK/PD studies, and analyze data.
- Familiarity with PK/PD tools (e.g., WinNonLin), data visualization and AI software; experience writing scientific reports and regulatory summaries.
Benefits:
- Total rewards package may include annual bonuses/incentives, equity awards, pension/retirement benefits, 401(k) match, health and wellness programs, insurance, paid time off, and family support benefits.
Application instructions:
- Apply now.
Responsibilities:
- Provide input and oversight for preclinical in vivo studies.
- Coordinate with and influence scientific teams conducting preclinical studies.
- Manage nonclinical PK studies.
- Analyze and present PK/PD data to project teams and senior management.
- Prepare summary reports for regulatory submissions.
- Serve as a subject matter expert on Preclinical PK/PD within Discovery-stage project teams; guide design of preclinical PK/pharmacology studies.
- Collaborate with internal groups (Therapeutic Proteins, Therapeutic Function Areas, Assay Development, Precision Medicine, Preclinical Operations, PPK/PD management) to develop and execute PK strategies.
- Communicate project team queries, expectations, and timelines to management.
- Conduct and report PK/PD analyses from preclinical study data.
- Work with Toxicology, Pathology, Clinical Pharmacology, and Quantitative Pharmacology (Drug Safety and Pharmacometrics) to deliver data and regulatory documents.
- Maintain knowledge of scientific literature, regulatory guidance, and PK/PD best practices.
Qualifications:
- PhD in Pharmacology, Pharmacokinetics, Biology/Molecular Biology, or Biochemistry with 8–10+ years of biotech/pharma experience.
- Deep theoretical/applied understanding of PK/PD to interpret therapeutic protein pharmacology/biology; experience with siRNA, CRISPR-based therapeutics, and/or cell therapies preferred.
- Proven ability to plan, coordinate, lead PK and/or PK/PD studies, and analyze data.
- Familiarity with PK/PD tools (e.g., WinNonLin), data visualization and AI software; experience writing scientific reports and regulatory summaries.
Benefits:
- Total rewards package may include annual bonuses/incentives, equity awards, pension/retirement benefits, 401(k) match, health and wellness programs, insurance, paid time off, and family support benefits.
Application instructions:
- Apply now.