Primary Responsibilities
- Lead and shape quantitative pharmacology strategy across oncology programs to inform key decisions (dose selection, trial design, go/no-go).
- Develop and implement integrated model-informed drug development (MIDD) strategies across development stages.
- Ensure modeling strategies align with regulatory expectations and business priorities.
- Lead, mentor, and develop a team of QP2 scientists (performance, hiring, retention, deliverable oversight).
- Serve as QP2 lead on assigned programs; represent QP2 in cross-functional teams/governance forums.
- Collaborate with Translational, Clinical, and Biostatistics teams; partner with preclinical teams to translate findings into clinical plans.
- Contribute to due diligence for business development/licensing.
- Develop and contribute to regulatory strategies; author/review INDs, CSRs, CTD modules, NDA/BLA submissions; represent the company with regulators/conferences.
Minimum Education
- Ph.D. in relevant discipline (β₯10 years pharma industry experience) OR Masterβs/PharmD/equivalent (β₯15 years, increasing responsibility/leadership).
Required Experience & Skills
- Background in relevant fields (biopharmaceutics/pharma sciences/pharmacimetrics/mathematics/computational biology or related) and oncology disease knowledge.
- Ability to lead interdisciplinary teams.
- Experience developing quantitative strategies impacting pipeline decisions.
- Experience independently authoring/defending marketing authorization filings (NDA/MAA).
- Inclusive, high-performance collaboration; manage ambiguity.
- Strong written/verbal communication and problem scoping/planning.
Required Skills
Clinical Development, Clinical Pharmacology, Cross-Functional Collaboration, Drug Development, Effective Written/Verbal Communication, Leadership, Oncology, Oncology Drug Development, Pharmacometrics, Regulatory Interactions/Responses, Stakeholder Relationship Management, Team Management, Translational PK/PD (PKPD).
Benefits
- Eligible for annual bonus and long-term incentive (if applicable).
Application Instructions
- Apply at https://jobs.merck.com/us/en (Workday Jobs Hub for current employees). Application deadline is stated on the posting.