Head, Program and Study Management Oncology
Merck
August 13, 2026
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Key Responsibilities
- Contribute to GCTO vision, strategy, and goals; align with R&D and GCD strategy.
- Serve as GCTO point of accountability for assigned TA(s); provide strategic operational input to the clinical development plan.
- Translate scientific/TA objectives into executable operational strategies; guide teams on competitive landscape, scientific rationale, and asset vision.
- Full end-to-end accountability for operational planning, execution, and delivery of the clinical program portfolio on time, within budget, and to highest quality.
- Drive cross-functional trial delivery strategies; assess monthly delivery risk and escalate via forums as needed.
- Provide execution excellence and senior oversight across phases; track KPIs/KQIs for milestones, cycle times (FPI, Site Ready 80%, Site Activation, Database Lock), enrollment/retention/data quality, LPI, quality metrics (protocol deviation, data/query, issue management, eTMF, CV/org charts, training).
- Act as primary escalation point for complex operational issues; ensure compliance with GCP, ICH, and global regulations; lead readiness for reviews, inspections, and audits.
- Provide TA expertise and act as key operational partner to Clinical leadership; build internal/external partnerships.
- Lead and develop a global team; build talent pipelines, mentorship, succession planning, and inclusive high-performance culture.
- Modernize clinical operations using innovative processes, simplification, and AI/automation; drive enterprise initiative adoption.
- Accountable for TA headcount and operating budget; lead vendor strategies and governance using KPIs/KQIs.
- Represent company in external scientific forums.
Educational Requirements
- Bachelor’s degree in a scientific-related discipline (strongly preferred).
- Advanced degree (Master’s/PharmD/PhD) in life sciences/medicine/related field (strongly preferred).
Required Experience/Knowledge/Skills
- 12+ years in pharma/biotech/CRO with primary focus on clinical trial operations and drug development.
- Proven single-point accountability for successful clinical program execution including pivotal registration trials/regulatory submissions.
- Experience building talent pipelines and developing future leaders.
- Digital/AI leadership implementing AI/automation/predictive analytics to modernize operations.
- Financial and operational stewardship; budget management and cost/cycle-time improvement.
- Strong GCP/ICH and global regulatory knowledge.
- Ability to influence in a matrix environment.
Required Skills (selected)
- Clinical trial operations/management, clinical risk management, operational excellence, stakeholder management/collaboration, KPI-driven delivery, continuous monitoring, change management.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Apply by the posting deadline (end date: 08/26/2026). Requisition ID: R407391.
- Contribute to GCTO vision, strategy, and goals; align with R&D and GCD strategy.
- Serve as GCTO point of accountability for assigned TA(s); provide strategic operational input to the clinical development plan.
- Translate scientific/TA objectives into executable operational strategies; guide teams on competitive landscape, scientific rationale, and asset vision.
- Full end-to-end accountability for operational planning, execution, and delivery of the clinical program portfolio on time, within budget, and to highest quality.
- Drive cross-functional trial delivery strategies; assess monthly delivery risk and escalate via forums as needed.
- Provide execution excellence and senior oversight across phases; track KPIs/KQIs for milestones, cycle times (FPI, Site Ready 80%, Site Activation, Database Lock), enrollment/retention/data quality, LPI, quality metrics (protocol deviation, data/query, issue management, eTMF, CV/org charts, training).
- Act as primary escalation point for complex operational issues; ensure compliance with GCP, ICH, and global regulations; lead readiness for reviews, inspections, and audits.
- Provide TA expertise and act as key operational partner to Clinical leadership; build internal/external partnerships.
- Lead and develop a global team; build talent pipelines, mentorship, succession planning, and inclusive high-performance culture.
- Modernize clinical operations using innovative processes, simplification, and AI/automation; drive enterprise initiative adoption.
- Accountable for TA headcount and operating budget; lead vendor strategies and governance using KPIs/KQIs.
- Represent company in external scientific forums.
Educational Requirements
- Bachelor’s degree in a scientific-related discipline (strongly preferred).
- Advanced degree (Master’s/PharmD/PhD) in life sciences/medicine/related field (strongly preferred).
Required Experience/Knowledge/Skills
- 12+ years in pharma/biotech/CRO with primary focus on clinical trial operations and drug development.
- Proven single-point accountability for successful clinical program execution including pivotal registration trials/regulatory submissions.
- Experience building talent pipelines and developing future leaders.
- Digital/AI leadership implementing AI/automation/predictive analytics to modernize operations.
- Financial and operational stewardship; budget management and cost/cycle-time improvement.
- Strong GCP/ICH and global regulatory knowledge.
- Ability to influence in a matrix environment.
Required Skills (selected)
- Clinical trial operations/management, clinical risk management, operational excellence, stakeholder management/collaboration, KPI-driven delivery, continuous monitoring, change management.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Apply by the posting deadline (end date: 08/26/2026). Requisition ID: R407391.