Associate Director, Preclinical and Translational PK/PD

About the role

The Associate Director role involves supporting PK and PK/PD requirements for early-stage drug discovery and IND projects. Work Location: Tarrytown, NY.

Schedule

Four days per week on site.

Responsibilities

• 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
• Preparing summary reports for regulatory submissions
• 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
• 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
• Experience writing scientific reports and regulatory summaries

Benefits

• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits
• 401(k) company match
• Health and wellness programs
• Fitness centers
• Insurance benefits (e.g., medical,