Semma Therapeutics, a biotechnology company focused on developing a stem cell-based cell therapy for Type 1 diabetes, is seeking a Medical Director to join its growing team. The successful candidate will serve as the Medical Lead and primary Medical Monitor for clinical trials that will be conducted on Semma therapeutics. The position reports to the Chief Medical Officer, and is located in Cambridge, MA.
- Collaborate in the preparation of the clinical development strategy by partnering with cross-functional multidisciplinary study team colleagues.
- 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
- Provide medical and development leadership for cross-functional teams Represent Semma to outside medical personal in the development of clinical protocols and study conduct
- MD. Board certification/eligibility in internal medicine and/or endocrinology is highly desired
- Minimum of 3 years Pharmaceutical/Biotech industry experience, including time managing clinical trials and clinical development programs
- Global clinical research experience and experience interacting with regulatory authorities is a plus
- Ability to work collaboratively in a fast-paced, team-based matrix environment
- Ability to work independently to resolve challenges
- Excellent oral and written communication skills
- Demonstrated experience in leading teams successfully, effectively, efficiently and on target
- Experience in clinical development of cellular therapies preferred
Please note that applicants should have authorization to work in the United States. Semma offers competitive pay, health insurance, time-off among other benefits. Please, fill out the form below and include your resume.