Role responsibilities:
- Provide strategic and scientific expertise and represent Clinical Pharmacology at relevant meetings.
- Provide Clinical Pharmacology subject matter support to new and ongoing clinical programs, primarily in Oncology.
- Proactively identify and provide significant PMx contributions for complex R&D programs addressing strategic needs and scientific/regulatory challenges.
- Contribute as an expert to overall strategic program development and communicate complex PMx strategies/results to the development team.
- Independently design and conduct/oversee development of PMx analysis plans using standardized or advanced techniques to perform PK/PD and other quantitative analyses; inform PMx management of results/issues in a timely manner.
- Serve as a scientific leader in PMx and provide mentorship.
- Prepare and deliver accurate, well-articulated nonclinical/clinical study reports and regulatory submission documents as appropriate.
Qualifications/requirements:
- PhD in Biology, Pharmacology, Engineering, Pharmacy (Pharm.D.), or Medicine (MD).
- 6+ years of relevant Clinical Pharmacology experience.
- Oncology experience strongly preferred (not required).