Responsibilities:
- Lead Oncology Global Clinical Development for new or marketed drugs in GI cancers.
- Manage full clinical development cycle: strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentations.
- Provide internal scientific leadership across cross-functional teams and interact with key opinion leaders.
- Evaluate pre-clinical/translational work for early clinical plans and INDs.
- Develop clinical development strategies incorporating science, regulatory requirements, competitive landscape, and commercial considerations.
- Plan and monitor clinical trials (design, operational plans, sites).
- Analyze/summarize clinical findings to support safety/efficacy decisions and regulatory filings/publications.
- Support internal/external research projects and business development assessments.
- Support other therapeutic areas with oncology-related clinical issues.
May include:
- Manage Directors/Senior Directors and supervise Clinical Team execution.
- Collaborate with Associate VP and cross-functional experts (commercial, regulatory, statistics, medical, manufacturing).
- Maintain scientific expertise and external investigator relationships; attend scientific meetings.
- Author development documents/budgets; facilitate global collaborations; travel ~20%.
Education:
- M.D. or M.D./Ph.D.
Required:
- Industry experience in GI cancers.
- 3+ years clinical medicine; 5+ years industry drug development.
- Demonstrated scientific scholarship; strong clinical medicine and biomedical research background.
- Interpersonal skills and team collaboration.
Preferred:
- Board Certified/Eligible in Oncology (and/or Hematology).
- Prior clinical research experience and prior publication.
Required skills:
Clinical Development, Clinical Trials, Clinical Trials Monitoring, Cross-Functional Teamwork, Drug Development, Gastrointestinal Cancer, Leading Project Teams, Oncology Trials, Research Methodologies, Results-Oriented, Scientific/Strategic Leadership.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).