Senior Director, Quantitative Systems Pharmacology – Oncology (Hybrid or Remote)
Merck
August 19, 2026
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Primary Responsibilities:
- Lead and shape QSP strategy across the oncology portfolio; ensure alignment with program goals.
- Lead, mentor, and develop quantitative scientists in a matrixed environment.
- Collaborate with QP2 Oncology, preclinical DMPK/modeling, biologists, clinicians, and other functions to apply mechanistic/QSP modeling for dose selection, combination strategies, and clinical trial design.
- Ensure high-quality, regulatory-grade QSP deliverables for internal decisions, submissions, and scientific advice meetings.
- Support regulatory strategy via QSP reports, briefing documents, and presentations.
- Build best practices for QSP modeling; promote scientific rigor, excellence, collaboration, and innovation.
- Partner with Translational Modeling/Discovery/Clinical Development leaders to define modeling strategies influencing program design and key decisions.
- Represent the company at conferences and external collaborations; stay current on emerging QSP methodologies.
- Manage budget planning and QSP vendor identification/outsourcing, including contract requisitions.
Minimum Education:
- Ph.D. plus 10+ years pharma drug development experience (systems pharmacology/biology, PKPD, math, chemical/biomedical engineering or related).
- OR Master’s or PharmD plus 15+ years experience with increasing responsibility and independence.
Required Experience/Qualifications:
- Extensive experience developing mechanistic PK-PD and QSP models for early/late-stage clinical decision-making.
- Demonstrated ability to lead interdisciplinary teams/taskforces.
- Oncology therapeutic area/disease knowledge.
- Mechanistic modeling experience relevant to ADCs and/or T-cell engagers with immune-axis (preferred).
- Experience with modeling/simulation software or programming (e.g., MATLAB, R, SimBiology, Python).
- Experience with external QSP vendors and applying QSP to IND/NDA and other global regulatory submissions.
- Strong written/verbal communication and interdisciplinary collaboration.
Required Skills:
- Clinical Pharmacology; Collaboration; Communication; Data Modeling; Drug Development; Modeling Software; Oncology; PKPD Modeling; Quantitative Models; Regulatory Submissions; Systems Biology.
Benefits:
- Eligible for annual bonus and long-term incentive (if applicable).
- Comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and sick/compassionate days.
- Lead and shape QSP strategy across the oncology portfolio; ensure alignment with program goals.
- Lead, mentor, and develop quantitative scientists in a matrixed environment.
- Collaborate with QP2 Oncology, preclinical DMPK/modeling, biologists, clinicians, and other functions to apply mechanistic/QSP modeling for dose selection, combination strategies, and clinical trial design.
- Ensure high-quality, regulatory-grade QSP deliverables for internal decisions, submissions, and scientific advice meetings.
- Support regulatory strategy via QSP reports, briefing documents, and presentations.
- Build best practices for QSP modeling; promote scientific rigor, excellence, collaboration, and innovation.
- Partner with Translational Modeling/Discovery/Clinical Development leaders to define modeling strategies influencing program design and key decisions.
- Represent the company at conferences and external collaborations; stay current on emerging QSP methodologies.
- Manage budget planning and QSP vendor identification/outsourcing, including contract requisitions.
Minimum Education:
- Ph.D. plus 10+ years pharma drug development experience (systems pharmacology/biology, PKPD, math, chemical/biomedical engineering or related).
- OR Master’s or PharmD plus 15+ years experience with increasing responsibility and independence.
Required Experience/Qualifications:
- Extensive experience developing mechanistic PK-PD and QSP models for early/late-stage clinical decision-making.
- Demonstrated ability to lead interdisciplinary teams/taskforces.
- Oncology therapeutic area/disease knowledge.
- Mechanistic modeling experience relevant to ADCs and/or T-cell engagers with immune-axis (preferred).
- Experience with modeling/simulation software or programming (e.g., MATLAB, R, SimBiology, Python).
- Experience with external QSP vendors and applying QSP to IND/NDA and other global regulatory submissions.
- Strong written/verbal communication and interdisciplinary collaboration.
Required Skills:
- Clinical Pharmacology; Collaboration; Communication; Data Modeling; Drug Development; Modeling Software; Oncology; PKPD Modeling; Quantitative Models; Regulatory Submissions; Systems Biology.
Benefits:
- Eligible for annual bonus and long-term incentive (if applicable).
- Comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and sick/compassionate days.