Clinical Pharmacology Lead (Manager)

1w1 week ago

Pfizer

Cambridge, US · Full-time · $106,000 – $176,600

About this role

Exciting opportunity in Clinical Pharmacology! Our Clinical Pharmacology Team seeks a Manager to support the Internal Medicine portfolio. Team members champion innovative MIDD use for efficient drug development and robust decision-making.

Pfizer leads in model informed drug discovery and development (MIDD), expanding influence. The role provides clinical pharmacology and MIDD components for clinical plans, offering expertise to project teams and regulatory interactions. Integrate pharmacokinetics, pharmacodynamics, patient characteristics, and diseases for rational strategies.

Work with multifunctional study teams as Clinical Pharmacology representative on Clinical Sub Teams and Development Teams. Ensure preclinical PK/PD knowledge supports safe human administration and predictive models before FIH. Oversee clinical pharmacology aspects like PK/PD analyses and biomarker strategies.

Design End-to-End MIDD plans conforming to best practices. Influence through publications, presentations, and scientific societies. Great environment for learning and professional growth.

Requirements

Pharm. D., M.D./Ph.D., or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or related discipline
Strong quantitative skills and expertise in mechanistic PK/PD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations using NONMEM, R, etc.
0+ years of industry experience
Excellent written and verbal communication skills
Knowledge of pharmacokinetics, pharmacodynamics, and model informed drug development (MIDD)
Experience integrating patient characteristics and disease states for study designs and dosing

Responsibilities

Act as Clinical Pharmacology representative on Clinical Sub Team, Development Team and other multifunctional teams
Provide expertise, leadership, and deliverables of clinical pharmacology for assigned projects
Design and execute clinical pharmacology plans and implement best practices on project teams
Work closely with other disciplines to ensure preclinical PK/PD knowledge for safe human administration and predictive models prior to FIH
Plan and oversee clinical pharmacology aspects including clinical development plan, PK/PD analyses, and PK/immunogenicity/biomarker strategies
Plan and oversee study level activities including protocol authoring, clinical phase oversight, and reporting
Ensure appropriate dose-range finding strategies leading to optimal doses and dosage regimens
Provide clinical pharmacology contributions to regulatory documents like IND, NDA/MAA