Associate Director Preclinical & Translational Pharmacokinetics/Pharmacodynamics
Regeneron
August 07, 2026
On-site
Tarrytown, NY
Clinical Research and Development
Role Summary
The Associate Director supports Pharmacokinetics (PK) and Pharmacokinetics/Pharmacodynamics (PK/PD) requirements for early-stage drug discovery and IND projects.
Responsibilities
- Provide input and oversight for preclinical in vivo studies supporting PK/PD requirements.
- Coordinate with and influence scientific teams conducting preclinical studies.
- Manage nonclinical Pharmacokinetics studies.
- Conduct, 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 and guide the design of preclinical PK/pharmacology studies.
- Collaborate with internal groups (Therapeutic Proteins, Therapeutic Function Areas, Assay Development, Precision Medicine, Preclinical Operations, and PPK/PD management) to develop and execute PK strategies.
- Communicate project team queries, expectations, and timelines to management.
- Partner with Toxicology, Pathology, Clinical Pharmacology, and Quantitative Pharmacology to deliver data and regulatory documents.
- Maintain current knowledge of PK/PD literature, regulatory guidance, and best practices.
Qualifications
- PhD in Pharmacology, Pharmacokinetics, Biology/Molecular Biology, or Biochemistry with 8–10+ years of relevant biotech/pharma experience.
- Deep theoretical and applied understanding of PK/PD; experience interpreting therapeutic protein pharmacology/biology. Experience with siRNA, CRISPR-based therapeutics, and/or cell therapies is beneficial.
- Proven ability to plan, coordinate, lead PK and/or PK/PD studies, and analyze related data.
- Familiarity with PK/PD tools (e.g., WinNonLin), data visualization/AI software; experience writing scientific reports and regulatory summaries.
Application
- Apply now.
The Associate Director supports Pharmacokinetics (PK) and Pharmacokinetics/Pharmacodynamics (PK/PD) requirements for early-stage drug discovery and IND projects.
Responsibilities
- Provide input and oversight for preclinical in vivo studies supporting PK/PD requirements.
- Coordinate with and influence scientific teams conducting preclinical studies.
- Manage nonclinical Pharmacokinetics studies.
- Conduct, 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 and guide the design of preclinical PK/pharmacology studies.
- Collaborate with internal groups (Therapeutic Proteins, Therapeutic Function Areas, Assay Development, Precision Medicine, Preclinical Operations, and PPK/PD management) to develop and execute PK strategies.
- Communicate project team queries, expectations, and timelines to management.
- Partner with Toxicology, Pathology, Clinical Pharmacology, and Quantitative Pharmacology to deliver data and regulatory documents.
- Maintain current knowledge of PK/PD literature, regulatory guidance, and best practices.
Qualifications
- PhD in Pharmacology, Pharmacokinetics, Biology/Molecular Biology, or Biochemistry with 8–10+ years of relevant biotech/pharma experience.
- Deep theoretical and applied understanding of PK/PD; experience interpreting therapeutic protein pharmacology/biology. Experience with siRNA, CRISPR-based therapeutics, and/or cell therapies is beneficial.
- Proven ability to plan, coordinate, lead PK and/or PK/PD studies, and analyze related data.
- Familiarity with PK/PD tools (e.g., WinNonLin), data visualization/AI software; experience writing scientific reports and regulatory summaries.
Application
- Apply now.