Senior Director, Quantitative Systems Pharmacology – Oncology (Hybrid or Remote)
Merck
August 19, 2026
Remote friendly (North Wales, PA)
United States
Clinical Research and Development
Primary Responsibilities:
- Lead and shape QSP strategy across the oncology portfolio; align with program goals and priorities.
- Lead, mentor, and develop a team of quantitative scientists in a matrixed role.
- Collaborate with preclinical DMPK/modeling teams, biologists, clinicians, and other functions to apply mechanistic/QSP modeling for dose selection, combination strategies, and clinical trial design.
- Deliver high-quality, regulatory-grade QSP outputs for internal decisions, submissions, and scientific advice meetings.
- Support regulatory strategy via QSP reports, briefing documents, and presentations.
- Develop best practices for QSP modeling; foster scientific rigor and innovation.
- Partner with Translational Modeling, Discovery, and Clinical Development to define modeling strategies influencing program design and decisions.
- Represent the company at conferences, collaborations, consortia, and working groups.
- Stay current on emerging QSP methodologies and promote innovation.
- Manage QSP budget planning, vendor identification, outsourcing, and contract requisitions.
Minimum Education Required:
- Ph.D. with 10+ years pharma drug development experience in systems pharmacology/systems biology/PKPD/math/engineering or related.
- OR Master’s or PharmD with 15+ years with increasing responsibility and independence.
Required Experience:
- Extensive experience developing mechanistic PK-PD and QSP models for early/late clinical decision-making.
- Demonstrated leadership of interdisciplinary teams/taskforces.
- Oncology therapeutic area/disease knowledge.
- Experience using modeling/simulation packages or languages (e.g., MATLAB, R, SimBiology, Python).
- Experience with external QSP vendors.
- Experience applying QSP modeling in IND/NDA and other regulatory submissions.
- Strong communication and interdisciplinary collaboration.
Required Skills:
- Clinical pharmacology, collaboration, communication, data modeling, drug development, modeling software, oncology, oncology drug development, pharmaceutical development, PKPD modeling, quantitative models, regulatory submissions, systems biology.
Application Instructions:
- Apply via https://jobs.merck.com/us/en.
- Lead and shape QSP strategy across the oncology portfolio; align with program goals and priorities.
- Lead, mentor, and develop a team of quantitative scientists in a matrixed role.
- Collaborate with preclinical DMPK/modeling teams, biologists, clinicians, and other functions to apply mechanistic/QSP modeling for dose selection, combination strategies, and clinical trial design.
- Deliver high-quality, regulatory-grade QSP outputs for internal decisions, submissions, and scientific advice meetings.
- Support regulatory strategy via QSP reports, briefing documents, and presentations.
- Develop best practices for QSP modeling; foster scientific rigor and innovation.
- Partner with Translational Modeling, Discovery, and Clinical Development to define modeling strategies influencing program design and decisions.
- Represent the company at conferences, collaborations, consortia, and working groups.
- Stay current on emerging QSP methodologies and promote innovation.
- Manage QSP budget planning, vendor identification, outsourcing, and contract requisitions.
Minimum Education Required:
- Ph.D. with 10+ years pharma drug development experience in systems pharmacology/systems biology/PKPD/math/engineering or related.
- OR Master’s or PharmD with 15+ years with increasing responsibility and independence.
Required Experience:
- Extensive experience developing mechanistic PK-PD and QSP models for early/late clinical decision-making.
- Demonstrated leadership of interdisciplinary teams/taskforces.
- Oncology therapeutic area/disease knowledge.
- Experience using modeling/simulation packages or languages (e.g., MATLAB, R, SimBiology, Python).
- Experience with external QSP vendors.
- Experience applying QSP modeling in IND/NDA and other regulatory submissions.
- Strong communication and interdisciplinary collaboration.
Required Skills:
- Clinical pharmacology, collaboration, communication, data modeling, drug development, modeling software, oncology, oncology drug development, pharmaceutical development, PKPD modeling, quantitative models, regulatory submissions, systems biology.
Application Instructions:
- Apply via https://jobs.merck.com/us/en.