Clinical Pharmacology Lead, Manager
Pfizer
3 months ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
ROLE SUMMARY:
- Provide clinical pharmacology and MIDD components of clinical plans and clinical pharmacology expertise to project teams and regulatory interactions.
- Integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics, and diseases to support rational development strategies, optimal study designs, and dosage regimen selections.
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 (with some guidance).
- Partner with other disciplines to ensure sufficient preclinical PK/PD knowledge to support safe human administration and predictive model structure prior to FIH.
- Plan and oversee clinical pharmacology aspects at the project level (e.g., clinical development plan; implementation and interpretation of PK/PD analyses; 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 support optimal doses and dosage regimens.
- Ensure 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.
- Provide end-to-end clinical pharmacology contributions to regulatory documents (e.g., briefing documents, regulatory queries, Investigator’s Brochures, IND, NDA/MAA).
- Stay abreast of literature, regulatory guidelines, and internal guidances/SOPs.
- Influence the external environment via publications, presentations, and representation at scientific societies/industrial consortium.
BASIC QUALIFICATIONS (Skills/Experience):
- Pharm. D., M.D./Ph.D., or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or related discipline.
- Strong quantitative skills, including mechanistic PK/PD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations (e.g., NONMEM, R).
- 0+ years of industry experience.
- Excellent written and verbal communication skills.
- Demonstrated presentation skills.
- Breadth of leadership experience; ability to influence and collaborate to achieve meaningful outcomes and business impact.
ADDITIONAL JOB DETAILS:
- Hybrid role: live within commuting distance and work on-site an average of 2.5 days per week or more as needed.
- Provide clinical pharmacology and MIDD components of clinical plans and clinical pharmacology expertise to project teams and regulatory interactions.
- Integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics, and diseases to support rational development strategies, optimal study designs, and dosage regimen selections.
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 (with some guidance).
- Partner with other disciplines to ensure sufficient preclinical PK/PD knowledge to support safe human administration and predictive model structure prior to FIH.
- Plan and oversee clinical pharmacology aspects at the project level (e.g., clinical development plan; implementation and interpretation of PK/PD analyses; 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 support optimal doses and dosage regimens.
- Ensure 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.
- Provide end-to-end clinical pharmacology contributions to regulatory documents (e.g., briefing documents, regulatory queries, Investigator’s Brochures, IND, NDA/MAA).
- Stay abreast of literature, regulatory guidelines, and internal guidances/SOPs.
- Influence the external environment via publications, presentations, and representation at scientific societies/industrial consortium.
BASIC QUALIFICATIONS (Skills/Experience):
- Pharm. D., M.D./Ph.D., or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or related discipline.
- Strong quantitative skills, including mechanistic PK/PD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations (e.g., NONMEM, R).
- 0+ years of industry experience.
- Excellent written and verbal communication skills.
- Demonstrated presentation skills.
- Breadth of leadership experience; ability to influence and collaborate to achieve meaningful outcomes and business impact.
ADDITIONAL JOB DETAILS:
- Hybrid role: live within commuting distance and work on-site an average of 2.5 days per week or more as needed.