Associate Director, Clinical Pharmacology Lead

Pfizer Pfizer · Pharma · MA

This role focuses on clinical pharmacology and model-informed drug discovery and development (MIDD) within the pharmaceutical industry. The Associate Director will provide expertise in pharmacokinetics, pharmacodynamics, and quantitative modeling to support drug development plans, clinical trial designs, and regulatory interactions. The role involves designing and executing clinical pharmacology plans, integrating knowledge of PK/PD and patient characteristics, and contributing to regulatory documents. It also includes developing new methodologies and influencing the external environment through publications and presentations.

What you'd actually do

  1. Act as Clinical Pharmacology representative on Clinical Sub Team and Development Team and other multifunctional teams as appropriate.
  2. Responsible for providing expertise, leadership, and deliverables of clinical pharmacology for the assigned projects within sphere of influence.
  3. Design and execute clinical pharmacology plans and implement clinical pharmacology best practices on project teams.
  4. Work closely with other disciplines to ensure that sufficient preclinical PK/PD knowledge exists to underwrite safe human administration and to establish the structure of a predictive model prior to FIH.
  5. Responsible for planning and overseeing clinical pharmacology aspects at the project level (e.g clinical development plan, implementation and interpretation of PK/PD analyses, PK/immunogenicity/biomarker measurement strategies etc.).

Skills

Required

  • Pharm. D., M.D./Ph.D., or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or related discipline.
  • 1+ years of industry experience in clinical pharmacology and/or clinical PK/PD and/or Pharmacometrics/Systems Pharmacology.
  • Intimate knowledge of drug development and experience in applying quantitative pharmacology approaches to knowledge integration.
  • Strong quantitative skills and expertise (e.g. experience in mechanistic PK/PD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations using NONMEM, R, etc.).
  • Excellent written and verbal communication skills.
  • Demonstrated presentation skills.
  • Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

What the JD emphasized

  • model informed drug discovery and development (MIDD)
  • quantitative pharmacology approaches
  • mechanistic PK/PD modeling/systems pharmacology