Responsibilities:
- Develop and apply model-based strategies (translational PK/PD, mechanistic models, population PK/PD, and clinical trial simulations) to support quantitative decision-making (dose selection, trial design, go/no-go).
- Represent QP2 on cardiometabolic discovery, early, and late clinical development teams using quantitative approaches.
- Partner with functional colleagues, external vendors, and strategic partners to build aligned, quantitative, model-informed approaches for drug discovery, development, and regulatory decisions.
- Collaborate across disciplines on study design, protocol development, execution, data interpretation, reporting, and results communication.
- Maintain knowledge of global regulatory expectations and contribute to regulatory document development and submission defense.
- Provide modeling input with pharmacometrics colleagues (strategies, analyses, interpretation, reporting).
Qualifications (Required):
- Ph.D. (4+ years), PharmD (6+ years), or MS (8+ years) in relevant field; increasing responsibility/independence in drug development, regulatory agency, or academia.
- Education in biopharmaceutics/pharmaceutical sciences/pharmacometrcs/chemical or biomedical engineering (or related quantitative discipline).
- Experience with population PK and PK/PD analyses using R, Matlab, Phoenix, NONMEM, Monolix, or similar tools.
- Strong written and verbal communication; ability to collaborate and plan complex work.
- Knowledge of modeling complex therapeutics and mechanistic modeling/QSP.
Preferred:
- Knowledge of cardiometabolic clinical drug development programs.
- Advanced math problem-solving, data analysis/interpretation, experimental design, and statistics.
- Understanding of biopharmaceutical/ADME properties of small molecules and/or biologics.
- Proven impact advancing decisions via model-based approaches.
Skills (Required): BI, Data Modeling, Data Science, Data Visualization, Machine Learning (ML), Software Development, Stakeholder Relationship Management, Waterfall Model.
Application Instructions:
- Apply via https://jobs.merck.com/us/en. Application deadline is stated on the posting. Requisition ID: R413149.