Clinical Pharmacology Lead, Manager
Pfizer
8 hours ago
Remote friendly (New York, NY)
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 clinical pharmacology best practices.
- Work with other disciplines to ensure sufficient preclinical PK/PD knowledge for safe human administration and to establish predictive model structure prior to FIH.
- Plan and oversee clinical pharmacology aspects at the project level (e.g., clinical development plan, PK/PD analyses and interpretation, PK/immunogenicity/biomarker measurement strategies).
- Plan and oversee study-level activities including protocol authoring, clinical phase oversight, and reporting.
- Support dose-range finding strategies with clinicians and statisticians to achieve optimal doses and dosage regimens.
- 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.
- Contribute to regulatory documents (e.g., briefing documents, regulatory queries, Investigator’s Brochures, IND, NDA/MAA).
- Stay abreast of literature, regulatory guidelines, internal guidances, and SOPs.
- Influence externally via publications, presentations, and representation at scientific societies/consortia.
BASIC QUALIFICATIONS:
- Pharm.D., M.D./Ph.D., or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or related discipline.
- Strong quantitative skills (e.g., mechanistic PK/PD modeling/systems pharmacology, meta-analyses, population modeling, clinical trial simulations using NONMEM, R).
- 0+ years of industry experience.
- Excellent written/verbal communication; demonstrated presentation skills.
- Demonstrated breadth of leadership experiences and ability to influence/collaborate to create business impact.
APPLICATION / 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.
- 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 clinical pharmacology best practices.
- Work with other disciplines to ensure sufficient preclinical PK/PD knowledge for safe human administration and to establish predictive model structure prior to FIH.
- Plan and oversee clinical pharmacology aspects at the project level (e.g., clinical development plan, PK/PD analyses and interpretation, PK/immunogenicity/biomarker measurement strategies).
- Plan and oversee study-level activities including protocol authoring, clinical phase oversight, and reporting.
- Support dose-range finding strategies with clinicians and statisticians to achieve optimal doses and dosage regimens.
- 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.
- Contribute to regulatory documents (e.g., briefing documents, regulatory queries, Investigator’s Brochures, IND, NDA/MAA).
- Stay abreast of literature, regulatory guidelines, internal guidances, and SOPs.
- Influence externally via publications, presentations, and representation at scientific societies/consortia.
BASIC QUALIFICATIONS:
- Pharm.D., M.D./Ph.D., or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or related discipline.
- Strong quantitative skills (e.g., mechanistic PK/PD modeling/systems pharmacology, meta-analyses, population modeling, clinical trial simulations using NONMEM, R).
- 0+ years of industry experience.
- Excellent written/verbal communication; demonstrated presentation skills.
- Demonstrated breadth of leadership experiences and ability to influence/collaborate to create business impact.
APPLICATION / 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.