Associate Director, Clinical Pharmacology Lead
Pfizer
2 days ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Role Responsibilities:
- Act as Clinical Pharmacology representative on Clinical Sub Team, Development Team, and other multifunctional teams as appropriate.
- Provide expertise, leadership, and clinical pharmacology deliverables for assigned projects.
- Design and execute clinical pharmacology plans and implement best practices.
- Collaborate with other disciplines to ensure sufficient preclinical PK/PD knowledge for safe human administration and predictive model structure prior to FIH.
- Plan and oversee project-level clinical pharmacology (e.g., clinical development plan, PK/PD analysis implementation/interpretation, PK/immunogenicity/biomarker measurement strategies).
- Plan and oversee study-level activities including protocol authoring, clinical phase oversight, and reporting.
- Ensure appropriate dose-range finding strategies with clinicians and statisticians to achieve optimal doses/regimens.
- Ensure end-to-end MIDD plan is designed and implemented according to best practices.
- Use innovative analytical methods to integrate PK, PD, patient characteristics, and disease states to optimize doses, regimens, and study designs.
- Contribute to regulatory documents (briefing documents, regulatory queries, Investigator’s Brochures, IND, NDA/MAA, etc.).
- Develop new methodologies via internal/external collaborations.
- Coach less experienced colleagues.
- Stay abreast of literature, regulatory guidelines, and internal guidance/SOPs.
- Influence external environment through publications, presentations, and scientific society/industrial consortium representation.
Basic Qualifications:
- 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.
- Knowledge of drug development and applying quantitative pharmacology approaches to knowledge integration.
- Strong quantitative skills (e.g., mechanistic PK/PD modeling/systems pharmacology, literature meta-analyses, population modeling, clinical trial simulations using NONMEM, R, etc.).
- Excellent written and verbal communication.
- Demonstrated presentation skills.
- Breadth of leadership experience (influencing/collaborating, developing/coaching others, overseeing colleagues to drive business impact).
Additional Job Details:
- Hybrid work; live within commuting distance and work on-site ~2.5 days/week or more as needed.
- Last date to apply: April 20, 2026.
- Act as Clinical Pharmacology representative on Clinical Sub Team, Development Team, and other multifunctional teams as appropriate.
- Provide expertise, leadership, and clinical pharmacology deliverables for assigned projects.
- Design and execute clinical pharmacology plans and implement best practices.
- Collaborate with other disciplines to ensure sufficient preclinical PK/PD knowledge for safe human administration and predictive model structure prior to FIH.
- Plan and oversee project-level clinical pharmacology (e.g., clinical development plan, PK/PD analysis implementation/interpretation, PK/immunogenicity/biomarker measurement strategies).
- Plan and oversee study-level activities including protocol authoring, clinical phase oversight, and reporting.
- Ensure appropriate dose-range finding strategies with clinicians and statisticians to achieve optimal doses/regimens.
- Ensure end-to-end MIDD plan is designed and implemented according to best practices.
- Use innovative analytical methods to integrate PK, PD, patient characteristics, and disease states to optimize doses, regimens, and study designs.
- Contribute to regulatory documents (briefing documents, regulatory queries, Investigator’s Brochures, IND, NDA/MAA, etc.).
- Develop new methodologies via internal/external collaborations.
- Coach less experienced colleagues.
- Stay abreast of literature, regulatory guidelines, and internal guidance/SOPs.
- Influence external environment through publications, presentations, and scientific society/industrial consortium representation.
Basic Qualifications:
- 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.
- Knowledge of drug development and applying quantitative pharmacology approaches to knowledge integration.
- Strong quantitative skills (e.g., mechanistic PK/PD modeling/systems pharmacology, literature meta-analyses, population modeling, clinical trial simulations using NONMEM, R, etc.).
- Excellent written and verbal communication.
- Demonstrated presentation skills.
- Breadth of leadership experience (influencing/collaborating, developing/coaching others, overseeing colleagues to drive business impact).
Additional Job Details:
- Hybrid work; live within commuting distance and work on-site ~2.5 days/week or more as needed.
- Last date to apply: April 20, 2026.