Senior Director, Quantitative Pharmacology and Pharmacometrics – Immuno-Oncology

Primary Responsibilities
Strategic & Scientific Leadership
- Lead and shape quantitative pharmacology strategy across oncology programs to inform key development decisions (e.g., dose selection, trial design, go/no-go).
- Develop and implement integrated model-informed drug development (MIDD) strategies across development stages.
- Ensure alignment of modeling strategies with regulatory expectations and business priorities.
- Maintain understanding of global regulatory expectations for small molecules, biologics (including new modalities such as ADCs and TCEs).

Team Leadership & Organizational Impact
- Lead, mentor, and develop a team of QP2 scientists (performance management, hiring, retention, talent development).
- Provide scientific and operational oversight to ensure high-quality, timely deliverables.
- Contribute to broader QP2/Oncology leadership initiatives.
- Support resource planning and allocation.

Program & Cross-Functional Leadership
- Serve as QP2 lead on assigned programs; represent QP2 in governance forums.
- Collaborate with Translational, Clinical, and Biostatistics teams to integrate quantitative insights.
- Partner with preclinical teams to translate nonclinical findings into clinical plans.
- Contribute to due diligence for business development/licensing.

Regulatory & External Engagement
- Develop and contribute to regulatory strategies; author/review INDs, CSRs, CTD modules, NDA/BLA submissions.
- Ensure delivery of high-quality clinical pharmacology and pharmacometric analyses.
- Represent the company with regulatory agencies and external collaborations.

Minimum Education
- Ph.D. in relevant field with ≥10 years industry experience; OR Master’s/PharmD/equivalent with ≥15 years industry experience.

Required Experience & Skills
- Background in biopharmaceutics/pharmaceutical sciences/pharmacogenomics/pharmacometrics, math/stats, computational biology, or related field.
- Oncology therapeutic area/disease knowledge.
- Ability to lead interdisciplinary teams/taskforces.
- Extensive experience building quantitative strategies to impact pipeline decisions.
- Ability to influence regulatory strategy; prior independent authoring/defending NDA/MAA filings.
- Inclusive, high-performance leadership; manage ambiguity.
- Relevant regulatory and quantitative pharmacology experience.
- Strong written/verbal communication and problem scoping/planning.

Required Skills
Clinical Development, Clinical Pharmacology, Cross-Functional Collaboration, Drug Development, Effective Written Communication, Leadership, Oncology, Oncology Drug Development, Pharmacometrics, Regulatory Interactions/Responses, Stakeholder Relationship Management, Team Management, Translational PK/PD, Verbal Communications.

Application Instructions
Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if current employee). Deadline is stated on the posting.