Role Responsibilities
- Plan and direct clinical research activities for new or marketed medicines in Late Stage Oncology (Late Stage therapeutic area).
- Manage the full clinical development cycle for assigned studies: study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.
- Evaluate pre-clinical/translational work to generate early clinical plans and IND applications.
- Develop clinical development strategies for investigational or marketed RCC drugs.
- Plan clinical trials (design, operational plans).
- Provide medical oversight and overall conduct of ongoing/new clinical trials.
- Analyze and summarize clinical findings to support safety/efficacy decisions, regulatory submissions, clinical study reports, and publication.
- Participate in internal and cross-functional research teams; support business development assessments of external opportunities.
May (additional)
- Engage with functional areas; collaborate with experts in commercialization, regulatory, statistics, and manufacturing.
- Provide expert scientific opinion internally/externally.
- Maintain scientific knowledge and build investigator networks; attend scientific meetings.
Education
- M.D. or M.D./Ph.D.
Required Experience/Skills
- Industry or senior faculty academia experience.
- Minimum 3 years clinical medicine.
- Minimum 3 years industry drug development or biomedical research (academia).
- Proven success overseeing clinical studies/protocols; track record in scientific scholarship.
- Strong interpersonal skills; team collaboration.
Preferred Experience/Skills
- Board Certified/Eligible in Oncology or related.
- Experience in GU malignancies; prior clinical research and publication.