Principal Clinical Pharmacologist – Immunooncology
| Company | Regeneron Pharmaceuticals |
|---|---|
| Location | Cambridge, MA, USA, Berkeley Heights, NJ, USA, Tarrytown, NY, USA |
| Salary | $148300 – $241900 |
| Type | Full-Time |
| Degrees | PharmD, PhD, MD |
| Experience Level | Senior, Expert or higher |
Requirements
- A PhD in Biology, Pharmacology, Engineering, Pharmacy (Pharm.D.), or Medicine (MD)
- At least 4 years of relevant Clinical Pharmacology experience
- Oncology experience is strongly preferred
Responsibilities
- Develop and maintain comprehensive strategic CP development plans for assigned programs with SGD supervision
- Provide CP subject matter expertise and presentations to the Clinical Study Team/ Development Team and Senior Management/Governance meetings with SGD supervision
- Collaborate and assist the Pre-clinical PK/PD Team and research teams to characterize preclinical PK/PD for prediction human PK/PD to accelerate clinical studies and achieve business goals
- Assist in drafting and finalization of clinical study protocols and study analysis plans
- Draft, finalize, and/or review CP reports
- Collaborate with the Medical Writing Team to incorporate PK/PD sections into clinical study reports
- Provide CP support of regulatory documents, communications, and presentations (eg, IND, health authority queries, preparation of BLA summary sections, addressing review inquiries) with SGD supervision
- Represent CP at pre-IND, Type C, preBLA, and other health authority meetings with SGD supervision
- Work closely with Quantitative Pharmacology to develop quantitative strategies and to deliver analyses and technical reports to support strategic development plans
- Actively publish work in scientific literature
Preferred Qualifications
- Strong communication skills to actively engage colleagues cross-functionally at all levels of the organization
- Innovative and flexible mindset
- Keen scientific interest
- Solid science background
- Passion for science