Manager, Clinical Pharmacology

Pfizer • La Jolla, CA

4d • Hybrid

About The Position

Will join a team of scientists supporting oncology development programs. Will be the Clinical Pharmacology Lead providing clinical pharmacology expertise to a multidisciplinary project team of an oncology program.

Requirements

• PhD in Pharmacokinetics, Clinical Pharmacology, Pharmacometrics, Engineering or PharmD
• Strong written and verbal communication skills
• Permanent work authorization in the United States.

Nice To Haves

• Experience interpreting PK and PK/PD data and integrating this knowledge into the clinical trial and overall clinical program.
• Hands-on experience with common software tools for PK and PK/PD analyses (e.g., R, NONMEM, Monolix)

Responsibilities

• Acts as Clinical Pharmacology representative on Clinical Sub Team and Development Team, as appropriate.
• Provides the clinical pharmacology components to Clinical Study Protocols, Clinical Study Reports, Clinical Pharmacology plans for programs.
• Provides clinical pharmacology expertise to oncology project teams including planning, design, and oversight of clinical pharmacology studies with operational assistance from clinical operations colleagues.
• Participates in implementing model-based drug development using quantitative approaches to address scientific questions arising during drug development.
• Provides non-compartmental analysis of PK data and executes appropriate PK/PD analyses such as population PK modeling, PK/PD modeling and conducting simulations.
• Plans relevant PK/PD analyses.
• Is responsible for integrating knowledge of pharmacokinetics, pharmacodynamics, patient characteristics, and disease states to optimize doses and dosage regimens throughout clinical drug development in collaboration with pharmacometrics and statistics groups (as relevant).
• Provides recommendations for clinical doses and dosing regimens (including drug-drug interactions, food effect, special group dosing) to the Clinical and Development teams and in regulatory documentation.
• Responsible for clinical pharmacology contributions to all regulatory documents including Investigator Brochures, EOP2 meetings.
• Supports the resolution of clinical pharmacology queries from drug regulatory agencies, takes a lead role in writing and reviewing responses to regulatory queries.
• Work in a matrix environment with a cross-functional clinical team.

Benefits

• Relocation support available
• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Ph.D. or professional degree