Clinical Pharmacology Lead, Manager
Pfizer
6 hours 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 deliverables of clinical pharmacology for assigned projects within scope.
- With some guidance, design and execute clinical pharmacology plans and implement best practices on project teams.
- Collaborate with other disciplines to ensure sufficient preclinical PK/PD knowledge for safe human administration and to establish a predictive model structure prior to FIH.
- Plan and oversee clinical pharmacology aspects at the project level (e.g., clinical development plan, PK/PD analyses, PK/immunogenicity/biomarker measurement strategies).
- Plan and oversee study-level activities including protocol authoring, clinical phase oversight, and reporting.
- With some guidance, ensure appropriate dose-range finding strategies leading to optimal doses and dosage regimens in patients (with clinicians and statisticians).
- Ensure appropriate design and implementation of an End-to-End MIDD plan aligned with best practices.
- Use innovative analytical methods to integrate PK, PD, patient characteristics, and disease states to optimize doses, dosage regimens, and study designs.
- With some guidance, provide End-to-End clinical pharmacology contributions to regulatory documents (briefing documents, regulatory queries, Investigator’s Brochures, IND, NDA/MAA, etc.).
- Stay abreast of literature, regulatory guidelines, and internal guidances and SOPs.
- Influence external environment via publications, presentations, and representation at scientific societies and industrial consortium.
Basic Qualifications:
- Pharm.D., M.D./Ph.D., or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or related discipline.
- Strong quantitative skills and expertise (e.g., mechanistic PK/PD modeling/systems pharmacology, literature meta-analyses, population modeling, clinical trial simulations using NONMEM, R).
- 0+ years of industry experience.
- Excellent written and verbal communication skills.
- Demonstrated presentation skills.
- Demonstrated leadership experiences and ability to influence and collaborate to create business impact.
Additional Job Details:
- Hybrid role; live within commuting distance and work on-site ~2.5 days/week or more as needed.
- Last date to apply: April 20, 2026.
Benefits (as stated):
- Eligible for participation in Pfizer’s Global Performance Plan (bonus target 15% of base salary) and share-based long-term incentive program.
- 401(k) with matching contributions and additional retirement savings contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical, prescription drug, dental, and vision coverage.
Compensation (as stated):
- Annual base salary range: $106,000.00 to $176,600.00.
Application Instructions:
- Apply by April 20, 2026.
- Act as Clinical Pharmacology representative on Clinical Sub Team, Development Team and other multifunctional teams as appropriate.
- Provide expertise, leadership, and deliverables of clinical pharmacology for assigned projects within scope.
- With some guidance, design and execute clinical pharmacology plans and implement best practices on project teams.
- Collaborate with other disciplines to ensure sufficient preclinical PK/PD knowledge for safe human administration and to establish a predictive model structure prior to FIH.
- Plan and oversee clinical pharmacology aspects at the project level (e.g., clinical development plan, PK/PD analyses, PK/immunogenicity/biomarker measurement strategies).
- Plan and oversee study-level activities including protocol authoring, clinical phase oversight, and reporting.
- With some guidance, ensure appropriate dose-range finding strategies leading to optimal doses and dosage regimens in patients (with clinicians and statisticians).
- Ensure appropriate design and implementation of an End-to-End MIDD plan aligned with best practices.
- Use innovative analytical methods to integrate PK, PD, patient characteristics, and disease states to optimize doses, dosage regimens, and study designs.
- With some guidance, provide End-to-End clinical pharmacology contributions to regulatory documents (briefing documents, regulatory queries, Investigator’s Brochures, IND, NDA/MAA, etc.).
- Stay abreast of literature, regulatory guidelines, and internal guidances and SOPs.
- Influence external environment via publications, presentations, and representation at scientific societies and industrial consortium.
Basic Qualifications:
- Pharm.D., M.D./Ph.D., or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or related discipline.
- Strong quantitative skills and expertise (e.g., mechanistic PK/PD modeling/systems pharmacology, literature meta-analyses, population modeling, clinical trial simulations using NONMEM, R).
- 0+ years of industry experience.
- Excellent written and verbal communication skills.
- Demonstrated presentation skills.
- Demonstrated leadership experiences and ability to influence and collaborate to create business impact.
Additional Job Details:
- Hybrid role; live within commuting distance and work on-site ~2.5 days/week or more as needed.
- Last date to apply: April 20, 2026.
Benefits (as stated):
- Eligible for participation in Pfizer’s Global Performance Plan (bonus target 15% of base salary) and share-based long-term incentive program.
- 401(k) with matching contributions and additional retirement savings contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical, prescription drug, dental, and vision coverage.
Compensation (as stated):
- Annual base salary range: $106,000.00 to $176,600.00.
Application Instructions:
- Apply by April 20, 2026.