Senior Medical Director, Clinical Development
Cambridge, MA
Clinical /
Fulltime /
On-site
Summary
The Senior Medical Director is a medical oncologist or a radiation oncologist who has clinical expertise in the oncology therapeutic area. This individual will be responsible for the clinical leadership of Phase 1-3 company sponsored studies and collaborate with imaging experts to provide clinical leadership for any phase 0 studies. Reporting to the CMO, this individual will partner with clinical operations, regulatory, medical writing, clinical pharmacology, stats/data management/programming, project management, and safety to provide clinical direction for company-sponsored clinical studies. In addition to clinical leadership for the company-sponsored studies, this individual will also be working with a clinical project scientist to review and provide input to investigator-initiated study proposals. When needed, this individual will also partner with the discovery team and the business development team to provide strategic input, to assess potential partnership and licensing opportunities.
Main Duties and Responsibilities
- Clinical Leadership:
- Primary responsibility for clinical and safety oversight of company sponsored Phase 0-3 clinical trials.
- Key clinical expert for study protocols and clinical development plans for each molecule in clinical development
- Key clinical stakeholder to answer health authority and IRB/ethics committee questions for the molecules in clinical development
- Works with medical writing and regulatory, and clinical operations to author protocols, investigator brochures, annual reports, clinical study reports and DSURs.
- Leads and when necessary supports clinical study start-up, data base locks, and study closeouts.
- Primary medical reviewer for ongoing and active company-sponsored studies
- Collaborate with cross functional partners to execute on clinical goals and objectives, ensuring timely achievement of milestones.
- Strategic Leadership:
- Lead clinical study teams, ensuring effective communication and coordination in partnership with the clinical operations team.
- Provide strategic input to potential partnership and licensing opportunities.
- Maintain the highest standards of clinical study and operational integrity.
Qualifications & Experience Required
- MD or equivalent degree with postdoctoral training in an oncology specialty.
- Minimum of 4 years of relevant clinical research experience for therapeutic molecules in a relevant academic setting or in the biotech/pharma industry
- RLT experience is nice but not mandatory
