Head, Program and Study Management Oncology
Merck
August 13, 2026
Remote friendly (North Wales, PA)
United States
Clinical Research and Development
Key Responsibilities
- Contribute to the development and execution of GCTO vision, strategy, and goals; ensure alignment with R&D and GCD strategy.
- Serve as single-point accountability for assigned TA(s); provide strategic operational input into the overall clinical development plan.
- Translate scientific/TA objectives into executable operational strategies; guide teams on competitive landscape, scientific rationale, and long-term asset vision.
- Provide end-to-end accountability for operational planning, execution, and delivery of the clinical program portfolio on time, within budget, and to the highest quality standards.
- Drive cross-functional trial delivery strategies; assess trial delivery risk monthly and escalate via forums as needed.
- Ensure execution excellence through continuous process improvement and KPI/KQI measurement across milestone/product delivery; cycle times (FPI, Site Ready 80%, Site Activation, Database Lock); enrollment/retention/data quality; LPI on time/within budget; quality metrics (protocol deviation rate, data/query, issue management, eTMF compliance, CV/org charts, training).
- Use predictive analytics and AI-driven insights to proactively identify/mitigate operational risks.
- Act as primary escalation point for complex operational issues; ensure activities comply with GCP/ICH and global regulations.
- Lead readiness for late-stage reviews, ops reviews, inspections, and audits.
- Provide people leadership for a global team; build talent pipelines, mentorship/education, succession planning, and a culture of accountability and continuous improvement.
- Champion modernization of clinical trial operations using AI/automation and quality-by-design processes.
- Manage TA resources (headcount and budget); drive vendor strategies with KPI/KQI oversight and governance participation.
- Represent the company externally and build/maintain an industry network.
Educational Requirements
- Bachelor’s degree required (scientific discipline strongly preferred).
- Master’s/PharmD/PhD in life sciences/medicine or related field strongly preferred.
Required Experience/Knowledge/Skills
- 12+ years progressive pharma/biotech/CRO experience with primary focus on clinical trial operations/drug development.
- Proven single-point accountability for successful clinical programs (including pivotal registration and regulatory submissions).
- Track record building talent pipelines and developing future directors/program leaders.
- Expertise in designated TA and TA-specific operational challenges.
- Proven digital & AI leadership (AI, automation, predictive analytics).
- Demonstrated financial/operational stewardship and cycle time improvement.
- Strong GCP/ICH and global regulatory knowledge.
- Strong matrix influence and ability to drive alignment across global R&D teams.
Required/Relevant Skills
- Clinical trial operations/management, clinical risk management, operational excellence, resource allocation, stakeholder management/collaboration, change management, innovation, KPI-driven management.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees); apply no later than the day before the posted end date (08/26/2026). Requisition ID: R407391.
- Contribute to the development and execution of GCTO vision, strategy, and goals; ensure alignment with R&D and GCD strategy.
- Serve as single-point accountability for assigned TA(s); provide strategic operational input into the overall clinical development plan.
- Translate scientific/TA objectives into executable operational strategies; guide teams on competitive landscape, scientific rationale, and long-term asset vision.
- Provide end-to-end accountability for operational planning, execution, and delivery of the clinical program portfolio on time, within budget, and to the highest quality standards.
- Drive cross-functional trial delivery strategies; assess trial delivery risk monthly and escalate via forums as needed.
- Ensure execution excellence through continuous process improvement and KPI/KQI measurement across milestone/product delivery; cycle times (FPI, Site Ready 80%, Site Activation, Database Lock); enrollment/retention/data quality; LPI on time/within budget; quality metrics (protocol deviation rate, data/query, issue management, eTMF compliance, CV/org charts, training).
- Use predictive analytics and AI-driven insights to proactively identify/mitigate operational risks.
- Act as primary escalation point for complex operational issues; ensure activities comply with GCP/ICH and global regulations.
- Lead readiness for late-stage reviews, ops reviews, inspections, and audits.
- Provide people leadership for a global team; build talent pipelines, mentorship/education, succession planning, and a culture of accountability and continuous improvement.
- Champion modernization of clinical trial operations using AI/automation and quality-by-design processes.
- Manage TA resources (headcount and budget); drive vendor strategies with KPI/KQI oversight and governance participation.
- Represent the company externally and build/maintain an industry network.
Educational Requirements
- Bachelor’s degree required (scientific discipline strongly preferred).
- Master’s/PharmD/PhD in life sciences/medicine or related field strongly preferred.
Required Experience/Knowledge/Skills
- 12+ years progressive pharma/biotech/CRO experience with primary focus on clinical trial operations/drug development.
- Proven single-point accountability for successful clinical programs (including pivotal registration and regulatory submissions).
- Track record building talent pipelines and developing future directors/program leaders.
- Expertise in designated TA and TA-specific operational challenges.
- Proven digital & AI leadership (AI, automation, predictive analytics).
- Demonstrated financial/operational stewardship and cycle time improvement.
- Strong GCP/ICH and global regulatory knowledge.
- Strong matrix influence and ability to drive alignment across global R&D teams.
Required/Relevant Skills
- Clinical trial operations/management, clinical risk management, operational excellence, resource allocation, stakeholder management/collaboration, change management, innovation, KPI-driven management.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees); apply no later than the day before the posted end date (08/26/2026). Requisition ID: R407391.