Associate Director – Quantitative Pharmacology and Pharmacometrics – Immune/Oncology
| Company | Merck |
|---|---|
| Location | Boston, MA, USA, San Francisco, CA, USA, North Wales, PA, USA, Linden, NJ, USA |
| Salary | $153800 – $242200 |
| Type | Full-Time |
| Degrees | Master’s, PharmD, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- Ph.D. with 1-3 years of pharmaceutical drug development experience relating to: PKPD, pharmacometrics, mathematics, statistics/ biostatistics, or chemical/biomedical engineering.
- Masters or PharmD with 3-5 years of experience, where ‘experience’ means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development.
- Demonstrated impactful experience with applications of pharmacometrics methods.
- Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.
- Proficiency in R, NONMEM or other similar programming language.
- Professional working proficiency in written and verbal communication.
Responsibilities
- Serving as an expert representative for QP2-IO on Oncology clinical development teams.
- Framing critical questions for optimizing model-based analyses on programs.
- Developing and executing model-based analyses including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative systems pharmacology (QSP) modeling, comparator modeling, thereby strengthening pharmacometrics capabilities on a continuous basis in decision making and driving pipeline impact.
- Strategizing and executing modeling of tumor size and survival endpoints including proportional hazards models.
- Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs)), and representing QP2-IO at regulatory meetings.
Preferred Qualifications
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No preferred qualifications provided.