Senior Research Investigator, Clinical Pharmacology
Position Summary
Clinical Pharmacology & Pharmacometrics plays a key role in the drug development process such that we plan, design and execute clinical pharmacology studies while maximizing the potential for model-informed drug development to drive decisions that inform the course of the clinical development program. The vision for Sr. Research Investigators in the group is to be able to function in a blended role that includes both classical clinical pharmacology skillsets combined with quantitative analysis skills. Given the breadth of the portfolio, Sr. Research Investigators in this group would have the opportunity to serve as the clinical pharmacology & pharmacometrics leader on compounds in both early and late stages of development as well as assets that are small and large molecules.
Key Responsibilities
- Contributes to compound development across various therapeutic areas and design of clinical studies with some supervision
- Ledesign of clinical pharmacology studies and manages data analysis, interpretation, and reporting
- Proficient in PK, PK/PD, and model informed drug development (MIDD) principles and analyses
- Collaborates on cross-functional drug development teams, regulatory submissions, and departmental initiatives
- Participates in interactions with health authorities
- Contributes to and owns modeling and simulation plan
- With some supervision, contributes to clinical development strategies of pipeline products
Qualifications & Experience
- Advanced Degree in related field (MS, Ph.D. or PharmD)
- Approximately 2+ years experience with demonstrated progression in clinical pharmacology and pharmacometrics knowledge
- General knowledge of general drug development process
- Programming familiarity experience (e.g., NONMEN, R, WinNonlin, SAS, Splus etc.)