Responsibilities
- Plan and direct clinical research for oncology drugs (new or marketed), managing the full clinical development cycle: study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation.
- Provide internal scientific leadership for cross-functional clinical trial support; interact with key opinion leaders.
- Evaluate pre-clinical/translational work to generate early clinical development plans and Investigational New Drug (IND) applications.
- Develop clinical development strategies (vaccines) aligned to science, regulatory requirements, competitive landscape, and commercial considerations.
- Plan and monitor clinical trials (design, operational plans, settings); analyze findings to support safety/efficacy decisions, regulatory submissions, clinical study reports, and publications.
- Participate in internal and joint internal/external research teams; support business development assessments and external opportunity evaluation.
- (When applicable) Manage oncology clinical development leaders and mentor direct reports.
- Oversee authoring of development documents, presentations, budgets, and position papers; manage internal stakeholder matrix; facilitate global external collaborations.
Qualifications
- MD or MD/PhD; board certified/eligible in medical oncology, radiation oncology, surgical oncology, or related preferred.
- 10+ years industry drug development/biomedical research (or equivalent academic + industry experience); 3+ years clinical medicine.
- Demonstrated scientific scholarship; strong knowledge of end-to-end drug development (ideally early and/or late development).
- Success running multiple studies/protocols; ability to originate program ideas and recommend trial expansion/curtailment.
- Experience designing, implementing, and analyzing clinical trials; strong interpersonal and communication skills; strong learning agility and growth mindset.