Manager, Clinical Pharmacology

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.
• 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.

Requirements

• PhD in Pharmacokinetics, Clinical Pharmacology, Pharmacometrics, Engineering or PharmD
• Strong written and verbal communication skills
• 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)
• Relocation support available
• Work Location Assignment: Flexible
• Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.
• This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.
• Relocation assistance may be available based on business needs and/or eligibility.
• Candidates must be authorized to be employed in the U.S. by any employer.
• U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
• Sunshine Act

Benefits

Additional Information

ROLE SUMMARY 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.

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Company Intel

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