Associate Director Translational Pharmacokinetics and Pharmacokinetic/Pharmacodynamic

About the role

The Associate Director role supports 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 these 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 and guide the design of preclinical PK/pharmacology studies.
• Collaborate 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.
• Communicate project team queries, expectations, and timelines to management.
• Conduct and report PK/PD analyses based on data from preclinical studies.
• Work 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.
• Maintain current knowledge of scientific literature, regulatory guidance, and best practices related to PK/PD.

Qualifications

• 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.
• 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, and experience writing scientific reports and regulatory summaries.

Benefits

Includes a competitive and comprehensive total rewards package which may include, depending on country and role: 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, dental, vision, life and disability), paid time off, and family support benefits.

Pay

$176,100.00 - $287,300.00 annually

Schedule

Full-time