[Senior] Medical Director, Hepatitis B Clinical Development
Location: Somerville, Massachusetts, 02143, United States
Finch Therapeutics is a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery platform to develop a novel class of orally administered biological drugs.With the capabilities to develop both complete and targeted microbiome therapeutics, Finch is advancing a rich pipeline of candidates designed to address a wide range of unmet medical needs. Finch’s lead candidate, CP101, is in late-stage clinical development for recurrent C. difficile infection (CDI). In June 2020, Finch announced that CP101 met its primary efficacy endpoint in PRISM3, the first of two pivotal trials to support the development of CP101 for the prevention of recurrent CDI. Finch is also developing CP101 for chronic hepatitis B, and FIN-211 for autism spectrum disorder. In partnership with Takeda, Finch is advancing FIN-524 and FIN-525 for ulcerative colitis and Crohn’s disease, respectively.
The primary responsibility of the [Senior] Medical Director, Hepatitis B Clinical Development, will be to provide medical expertise, clinical development experience and leadership necessary to advance Finch’s Hepatitis B microbiome therapeutic candidate through different phases of development. The [Senior] Medical Director will be a key driver of protocol design and medical oversight for study protocols in all phases of development.
The [Senior] Medical Director will also support attainment of corporate strategic objectives by contributing their clinical, scientific and development expertise to business development initiatives and development plans for investigator-initiated studies in HBV and/or related studies in the Gut-Liver axis. This position will report to the VP of Clinical Development.
- Participate in the creation of clinical development plans for assigned programs typically in Phase 1b or 2 of development, in consultation with cross-functional team members.
- Drive the design and preparation of clinical protocols and support the creation of FDA/EMA/Health Canada/Australia/New Zealand documents (e.g., INDs, annual reports, meeting requests, briefing books) and other relevant clinical documents.
- Function as medical monitor for assigned studies.
- Provide leadership in and assessment of medical and safety related questions.
- Interface with Key Opinion Leaders to support the development of compelling clinical development strategies and help optimize program plans and protocols.
- Work closely with cross-functional team members to ensure planning and execution of clinical trials to meet key milestones, maintain timelines and keep within agreed budget.
- Coordinate with the Clinical Operations team and/or Contract Research Organization on MD-to-MD related trial issues.
- Play a key role in the development of analysis plans, and in the review, interpretation and communication of clinical trial data from safety and efficacy trials; assist in generating the study reports and publications from these trials.
- Support academic partners and translational medicine efforts to effectively advance pipeline programs.
- An MD or DO degree from a recognized medical school with residency and/or clinical fellowship training in Hepatology/ID/Virology/Immunology/GI or Microbiology is preferred.
- 5+ years of pharmaceutical/biotech-industry experience in clinical development or at a Contract Research Organization, ideally with experience in Phase 1 and 2 clinical development.
- Experience in anti-viral drug development, preferably HBV is preferred.
- Translational medicine and/or microbiome expertise a significant plus (not required).
- An understanding of strategic and operational aspects of clinical research and product development.
- General knowledge of regulatory requirements.
- Persuasive, effective and flexible in personal interactions at all levels, with strong oral and written communication capabilities.
- Excellent ability to lead and work in cross-functional teams with a collaborative style that builds alliances and emphasizes integrity, results, collegiality and effective teamwork in a dynamic and rapidly changing environment.
- Strong project management and problem-solving skills.
- Displays sense of urgency, and a willingness to roll up sleeves to get work done.
More About Finch
Here at Finch, we strive to create the best work environment and experience for you through our formal benefits programs and fringe perks. Together, we hope that we’ll create a fun & supportive environment in and out of the workplace as we strive to create a new class of therapeutics together to help patients.
- Our formal benefits include medical, dental, and vision coverage through Harvard Pilgrim in addition to life insurance and long-term & short-term disability policies. We offer discretionary and flexible paid time off policies. Should you choose to start or grow your family while working at Finch, we aspire to lead our peers by offering several months of paid parental leave. We also offer a generous non-discretionary 401K contribution to help teammates save for life beyond Finch in the future and other savings and investment opportunities.
- We also try to keep the workplace an inspiring and motivating place to work with our fringe perks. Our facilities in Somerville, MA include an in-office gym with a shower and towel service, fully stocked kitchen with free snacks, iced coffee & flavored/sparkling waters on tap, and highly subsidized meals through LeanBox. We sponsor ride-sharing to and from the office from preset locations around Boston, Cambridge, and Somerville. We are always evaluating our fringe perks and hope to grow them alongside our team.
*Only facility-dependent employees are working on-site in Somerville until further notice.
Equal Opportunity Employer
We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. Finch will make reasonable accommodations for qualified individuals with disabilities, in accordance with applicable law.