Associate Director, Quantitative Pharmacology and Pharmacometrics - Immuno-Oncology (QP2‑IO)
$156.9k - $247kMerck
Associate Director role in quantitative pharmacology and pharmacometrics for immuno-oncology drug development. The position involves leading model-based analyses, regulatory strategy, and cross-functional collaboration within clinical development programs from post-Phase 1 through registration.
Responsibilities
- Serve as quantitative pharmacology expert on oncology clinical development teams
- Develop and execute population PK, exposure-response, and disease progression models
- Design and optimize model-based analyses including tumor size and survival endpoint modeling
- Author regulatory documents (INDs, CSRs, CTDs) and represent group at regulatory meetings
- Collaborate across functional areas and external partners to establish quantitative frameworks for decision-making
Requirements
- Ph.D. in biopharmaceutics, pharmaceutical sciences, pharmacometrics, or related field with 3+ years experience
- PharmD or M.S. in related field with 5-7 years pharmaceutical drug development experience
- Demonstrated expertise applying pharmacometrics methods in drug development
- Proficiency in R, NONMEM, or similar programming languages
- Strong statistical analysis, experimental design, and mathematical problem-solving skills
- Professional-level written and verbal communication abilities
- Knowledge of regulatory expectations for oncology drugs (small molecules and biologics)
Vacancy posted 20 days ago
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