Executive Director, Asset Development Team Leader
Merck
9 hours ago
Remote friendly (North Wales, PA)
United States
Clinical Research and Development
Responsibilities:
- Lead strategy, oversight, and delivery of end-to-end oncology drug activities across discovery through reimbursement.
- Develop, align, execute, and communicate overall asset strategy.
- Create, align, execute, and adapt asset strategy cross-functionally; lead asset development team.
- Identify registrational opportunities for preclinical/early clinical candidates; evaluate preclinical/translational work to plan early clinical development and Investigational New Drug (IND) applications.
- Develop clinical development strategies incorporating scientific advances, regulatory requirements, competitive landscape, and commercial needs.
- Prioritize clinical trials (design, operational plans, settings) based on internal/external factors.
- Support biomarker strategy and diagnostic readiness.
- Support safety management (safety governance, dose adjustments, supportive care optimization).
- Lead development and communication of asset messaging; secure governance alignment.
- Participate in internal/joint research teams and support business development assessments of external opportunities.
- Manage Directors/Senior Directors (when applicable); mentor and develop direct reports.
Education:
- M.D. or MD/PhD with oncology experience; board certified/eligible in related oncology/hematology disciplines preferred.
Required experience/skills:
- 5+ years industry drug development (relevant therapeutic area) and 5+ years clinical experience.
- Designed/executed/reported phase 3 or registrational studies; supported label submissions and post-approval launch readiness (e.g., publication planning, guideline submission, HTA negotiations).
- Regulatory agency clinical lead experience (dose justification; phase 3 design; BLA/sBLA; global submissions; diagnostic use).
- Matrix/stakeholder governance experience; KOL management; commercialization/reimbursement understanding; manufacturing parameter awareness.
Required skills (examples): Asset Development, Clinical Development/Research/Trials, Leadership, Oncology, Safety Management, Strategic Leadership.
Application instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is listed on the posting.
Travel:
- ~20% company travel.
- Lead strategy, oversight, and delivery of end-to-end oncology drug activities across discovery through reimbursement.
- Develop, align, execute, and communicate overall asset strategy.
- Create, align, execute, and adapt asset strategy cross-functionally; lead asset development team.
- Identify registrational opportunities for preclinical/early clinical candidates; evaluate preclinical/translational work to plan early clinical development and Investigational New Drug (IND) applications.
- Develop clinical development strategies incorporating scientific advances, regulatory requirements, competitive landscape, and commercial needs.
- Prioritize clinical trials (design, operational plans, settings) based on internal/external factors.
- Support biomarker strategy and diagnostic readiness.
- Support safety management (safety governance, dose adjustments, supportive care optimization).
- Lead development and communication of asset messaging; secure governance alignment.
- Participate in internal/joint research teams and support business development assessments of external opportunities.
- Manage Directors/Senior Directors (when applicable); mentor and develop direct reports.
Education:
- M.D. or MD/PhD with oncology experience; board certified/eligible in related oncology/hematology disciplines preferred.
Required experience/skills:
- 5+ years industry drug development (relevant therapeutic area) and 5+ years clinical experience.
- Designed/executed/reported phase 3 or registrational studies; supported label submissions and post-approval launch readiness (e.g., publication planning, guideline submission, HTA negotiations).
- Regulatory agency clinical lead experience (dose justification; phase 3 design; BLA/sBLA; global submissions; diagnostic use).
- Matrix/stakeholder governance experience; KOL management; commercialization/reimbursement understanding; manufacturing parameter awareness.
Required skills (examples): Asset Development, Clinical Development/Research/Trials, Leadership, Oncology, Safety Management, Strategic Leadership.
Application instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is listed on the posting.
Travel:
- ~20% company travel.