Manager, Clinical Pharmacology

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.

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.

Qualifications

• Required: 0-2 years of post-graduate experience
• Required: Strong written and verbal communication skills
• Preferred: Experience interpreting PK and PK/PD data and integrating this knowledge into the clinical trial and overall clinical program.
• Preferred: Hands-on experience with common software tools for PK and PK/PD analyses (e.g., R, NONMEM, Monolix)

Education

• PhD in Pharmacokinetics, Clinical Pharmacology, Pharmacometrics, Engineering or PharmD

Additional Requirements

• This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.