Primary Responsibilities
• Serve as an expert representative for QP2-IO on Oncology development teams.
• Frame critical questions and strategy to optimize model-based analyses.
• Develop and execute model-based analyses: translational PK/PD, population PK, exposure-response, clinical trial design simulation, disease progression models, QSP modeling, comparator modeling.
• Strategize and execute modeling of tumor size and survival.
• Maintain knowledge of global regulatory expectations in Oncology; author regulatory documents (INDs, CSRs, CTDs) and represent QP2-IO at regulatory meetings.
• Mentor and/or supervise junior staff.
Minimum Education
• Ph.D. with 7+ years drug development experience in PK/PD, pharmacometrics, mathematics, statistics/biostatistics, or chemical/biomedical engineering.
• Masters or PharmD with 9+ years experience with increasing responsibility and independence.
Required Experience/Qualifications
• Demonstrated impact using pharmacometrics methods.
• Experience with IND/NDA and other global regulatory submissions.
• Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.
• Track record of increasing responsibility and driving decisions using model-based approaches.
• Proficiency in R, NONMEM, MATLAB, Monolix or other modeling software.
• Proficiency in written and verbal communication.
Required Skills
• Clinical pharmacology
• Communication
• Data modeling/visualization
• Drug development
• Modeling software
• Pharmacology
• Pharmacometrics
• Program leadership
• Stakeholder relationship management
Preferred Skills
• ADCs
• Biologics
• Oncology
• Small molecule drugs
• T cells
Application

Apply at https://jobs.merck.com/us/en (or via Workday Jobs Hub). Use the posting deadline shown on the listing; Requisition ID: R398667.