Vice president, clinical development
Vedanta is pioneering the development of a new class of therapies that act by modulating the human microbiome. Modulation of the human microbiota holds enormous promise to treat a broad range of immune, infectious, and metabolic diseases in ways that are completely different to existing drug classes. Breakthrough discoveries of our scientific team in the field of mucosal immunology have led to the first rationally designed drug candidates in the microbiome field. Vedanta was founded by PureTech Ventures and a team of world renowned experts in immunology and microbiology.
Position Description / Responsibilities
The Vice President of Clinical Development will be a key member of Vedanta’s management team, and will be critical to shaping Vedanta’s overall strategic direction as well as participating in key operational decisions. The candidate will build a highly effective clinical development function at Vedanta. He/she will be a strong leader, a strategic thinker, with entrepreneurial mindset, and goal-oriented. The candidate will bring a strong knowledge of early clinical development and translational clinical trials, protocol design, experience in working with KOLs and CROs, and a strong clinical trial execution record. Previous leadership of programs transitioning to the clinic is highly desirable. Vedanta is currently pursuing indications ranging from Infectious Disease and Autoimmunity, to Immuno-oncology. Experts in these therapeutic areas, as well as candidates with broad therapeutic area experience and/or complementary and relevant scientific expertise are of interest. Experience in co-development, including Joint Steering Committees, as well as with regulatory filings, particularly filing for orphan or breakthrough designations, is of interest but not required. The role will report into Vedanta’s CEO. Location is Cambridge, MA.
- Lead execution of all clinical development efforts, including trial design, operations, data analysis, regulatory input, etc., utilizing a highly effective process to meet tight timelines and budgets
- Develop robust clinical development strategy that is consistent with Vedanta’s overall strategic priorities
- Build a highly functional clinical development organization, including team roadmap, hiring and developing team members
- Drive Vedanta’s external clinical and medical relationships, in particular with KOLs and CROs, and support the regulatory function in dealings with the FDA and other regulatory bodies
- Act as a key member of Vedanta’s management team, to provide input into overall company strategy and key day-to-day operational decisions, and interact (as required) with investors, media, etc.
- Lead medical due diligence and partnership efforts to identify and validate new disease areas, working with Vedanta’s cross-functional teams including the future head of business development.
- Serve as cross-functional leader on all clinical work streams.
- 5+ years of experience in clinical development in an industry setting
- MD degree is required
- Experience in early-stage clinical programs and translational work
- Track record of designing and executing robust clinical studies, experience working with CROs and interacting with regulatory bodies
- Prior work experience in entrepreneurial setting is preferred
- Prior experience as program leader is preferred
- Effective leader, with the ability to attract and develop high quality individuals and build teams
- Strong interpersonal skills
- Personal characteristics of integrity, team work, can-do-attitude and personal excellence
- Marked proficiency in clinical/medical writing and verbal communication.
- Experience across the drug development process, including clinical and non-clinical study design and execution.