Reporting to the CMO, this Senior Medical Director will serve as the Medical Lead for Graft vs Host disorder trials. Working closely with the CMO, the Senior Medical Director will set the clinical development strategy and will work with cross-functional multidisciplinary study teams on clinical trial design and execution.
- Prepare and execute the clinical development plans, in conjunction with other relevant functional areas,
- Serve as medical monitor for the assigned trials, assessing issues related to protocol conduct and subject safety.
- Participate in the development of study protocols, statistical analysis plans, investigator's brochures, and other key study documents in conjunction with other line functions and with minimal guidance
- Serve on cross-functional study teams for assigned trials, working with other team members to achieve efficient, high-quality study execution, and data analysis
- Participate in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, safety reports, responses to regulatory authorities, clinical study reports, and other documents as appropriate
- Interface with regulatory authorities as appropriate
- Act as liaison between clinical development and other internal groups at Seres for assigned studies
- Provide medical and development leadership for cross-functional teams, including for external innovation/business development
- Represent the company to outside medical personal in the development of clinical protocols and study conduct
- Represent the company to outside stakeholders
- MD, or DO
- Minimum of 5 years Pharmaceutical/Biotech industry experience, including time managing clinical trials and clinical development programs
- Board certification/eligibility, another relevant specialty area, is highly desired
- Clinical development and/or clinical experience in rare disease
- Ability to work collaboratively in a fast-paced, team-based matrix environment