Director, Quantitative Pharmacology and Pharmacometrics – Oncology
Merck
13 days ago
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Director, Quantitative Pharmacology & Pharmacometrics – Immune/Oncology (QP2-IO)
Primary Responsibilities:
- Serve as QP2-IO expert representative on Oncology development teams.
- Frame critical questions and develop 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, QSP modeling, comparator modeling).
- Strategize and execute modeling of tumor size and survival.
- Understand 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 7+ years in pharmaceutical drug development (PK/PD, pharmacometrics, math, statistics/biostatistics, or chemical/biomedical engineering).
- OR Masters or PharmD with 9+ years with increasing responsibility/independence.
Required Experience:
- Demonstrated impact using pharmacometrics methods.
- Experience with IND/NDA and other global regulatory submissions.
- Experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.
- Proven increasing responsibility and impact driving decisions via model-based approaches.
- Proficiency in R, NONMEM, MATLAB, Monolix, or similar modeling software.
- Strong written and verbal communication.
Required Skills:
- Clinical Pharmacology, Data Modeling/Visualization, Drug Development, Modeling Software, Pharmacology, Pharmacometrics, Program Leadership, Stakeholder Relationship Management.
Preferred Skills:
- ADC, Biologics, Oncology, Small Molecule Drugs, T Cells.
Application:
- Apply at https://jobs.merck.com/us/en. Application deadline is stated on the posting.
Requisition ID: R398667
Primary Responsibilities:
- Serve as QP2-IO expert representative on Oncology development teams.
- Frame critical questions and develop 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, QSP modeling, comparator modeling).
- Strategize and execute modeling of tumor size and survival.
- Understand 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 7+ years in pharmaceutical drug development (PK/PD, pharmacometrics, math, statistics/biostatistics, or chemical/biomedical engineering).
- OR Masters or PharmD with 9+ years with increasing responsibility/independence.
Required Experience:
- Demonstrated impact using pharmacometrics methods.
- Experience with IND/NDA and other global regulatory submissions.
- Experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.
- Proven increasing responsibility and impact driving decisions via model-based approaches.
- Proficiency in R, NONMEM, MATLAB, Monolix, or similar modeling software.
- Strong written and verbal communication.
Required Skills:
- Clinical Pharmacology, Data Modeling/Visualization, Drug Development, Modeling Software, Pharmacology, Pharmacometrics, Program Leadership, Stakeholder Relationship Management.
Preferred Skills:
- ADC, Biologics, Oncology, Small Molecule Drugs, T Cells.
Application:
- Apply at https://jobs.merck.com/us/en. Application deadline is stated on the posting.
Requisition ID: R398667