Director, Quantitative Pharmacology and Pharmacometrics β Immune/Oncology (QP2-IO)
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, including translational PK/PD, population PK models, exposure-response models, clinical trial design simulation, disease progression models, QSP modeling, and 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 Required:
- Ph.D. with at least 7 years of pharmaceutical drug development experience in PK/PD, pharmacometrics, mathematics, statistics/biostatistics, or chemical/biomedical engineering.
- Alternatively, Masterβs or PharmD with at least 9 years of experience with increasing responsibility and independence.
Required Experience:
- Demonstrated impact with pharmacometrics methods.
- Experience with IND, NDA, and other global regulatory submissions.
- Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.
- Increasing responsibility/independence and impact driving drug development decisions via model-based approaches.
- Proficiency in R, NONMEM, MATLAB, Monolix, or other modeling software.
- Professional written and verbal communication.
Required Skills:
- Clinical Pharmacology, Data Modeling, Data Visualization, Drug Development, Modeling Software, Pharmacology, Pharmacometrics, Program Leadership, Stakeholder Relationship Management, Communication.
Preferred Skills:
- Antibody Drug Conjugates (ADC), Biologics, Oncology, Small Molecule Drugs, T Cells.
Application Instructions:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).