Associate Director Translational Pharmacokinetics and Pharmacokinetic/Pharmacodynamic

Regeneron Pharmaceuticals • Tarrytown, GA

4d • Onsite

About The Position

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. The daily responsibilities of this role include: 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.

Requirements

• PhD in Pharmacology, Pharmacokinetics, Biology/Molecular Biology, or Biochemistry.
• 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.
• 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.
• Excellent written and verbal communication, presentation, influencing, and leadership skills.

Responsibilities

• Providing input and oversight for preclinical in vivo studies.
• Coordinating with and influencing scientific teams conducting preclinical studies.
• Managing nonclinical PK studies.
• Analyzing and presenting PK/PD data to project teams and senior management.
• Preparing summary reports for regulatory submissions.
• Serving as a subject matter expert on Preclinical PK/PD within Discovery-stage project teams.
• Guiding the design of preclinical PK/pharmacology studies.
• Collaborating with various internal groups 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 to deliver data and regulatory documents supporting project progression.
• Maintaining current knowledge of scientific literature, regulatory guidance, and best practices related to PK/PD.

Benefits

• Health and wellness programs (including medical, dental, vision, life, and disability insurance)
• Fitness centers
• 401(k) company match
• Family support benefits
• Equity awards
• Annual bonuses
• Paid time off
• Paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree