Vice President of Global Drug Safety & Pharmacovigilance
Location: Somerville, Massachusetts, 02143, United States
Finch is a clinical-stage company developing novel microbiome drugs to serve patients with serious unmet medical needs. Our machine learning-based platform mines molecular data collected from human interventional studies to identify the microbial communities driving positive patient outcomes in different disease areas. By developing drugs from microbial communities that have already demonstrated therapeutic effects in humans, we are pioneering a new approach to drug discovery and rapidly transforming the promise of the microbiome into a reality for patients.
Our lead therapeutic candidate, CP101, is initially targeting the prevention of recurrent C. difficile infection (CDI). CP101 recently met its primary endpoint in a large placebo-controlled trial in recurrent CDI, providing the first positive pivotal data for an oral microbiome drug candidate. We also have programs targeting the treatment of chronic hepatitis B, children with autism and serious gastrointestinal symptoms, as well as two programs partnered with Takeda Pharmaceuticals targeting inflammatory bowel disease.
Reporting to the CMO, the Vice President of Global Drug Safety & Pharmacovigilance will be responsible for the strategic implementation, execution, and management of pharmacovigilance and risk management activities in conjunction with the Company’s development and planned commercial activities, industry standards, and compliance with global regulations. The Vice President will lead and provide oversight for the pharmacovigilance, drug safety and risk management functions for investigational and marketed products, ensuring proactive and timely risk-benefit assessments of safety data.
Responsibilities / Duties
- Oversees and directs all aspects of global pharmacovigilance and risk management activities for investigational compounds and marketed products; actively participates in oversight of patient safety in all clinical trials.
- Oversees and directs all aspects of donor medical sciences for a novel donor source material program.
- Provides strategic planning, implementation, and management of drug safety activities to support clinical development of company products.
- Designs, directs, and conducts ongoing safety surveillance of company drug products using internal and external resources to ensure delivery of high-quality pharmacovigilance services.
- Provides oversight of all clinical safety activities including review of MedDRA coding of AEs, con-meds, and processing of SAEs through the entire lifecycle including preparation of analyses of similar events (ASE) for unexpected and related serious adverse events (SUSARs) from clinical trials.
- Directs the development, preparation, and compliance of periodic and annual safety reports (e.g., DSUR, PSUR, periodic line listings, BLA safety updates), investigator communications, product labeling/package inserts and other reports, as necessary.
- Provides expert safety review input into all critical documents for clinical development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs).
- Lead role to respond and resolve safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans.
- Manages internal employees and external contractors to ensure delivery of quality drug safety and pharmacovigilance services, including selecting, developing, training, and evaluating team to ensure the efficient operation of the drug safety function.
- Monitors industry best practices and changes in global safety regulations and guidelines. Recommends changes and upgrades to existing departmental policies, SOPs and systems to ensure global regulatory compliance.
- Collaborates with teams across the organization, including clinical development, clinical operations, quality, and regulatory, to provide input on all safety and PV issues including review of clinical study protocols, development plans, INDs and serious adverse events.
- Ensurse risk reduction strategies are included in relevant documents such as clinical study protocols.
- Ensures the oversight of uniform and timely processing of adverse event reports.
- Provides technical approval for investigator brochures, protocols, informed consents, final study reports.
- Maintains an environment of continuous improvement
- M.D. degree and 10+ years ofpharmaceutical safety experience. Experience working in cell therapy, biologics or with donor-derived products is a plus.
- Expert knowledge of FDA safety regulations, ICH guidelines, EU GVP, and applicable regulatory guidance.
- Expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities.
- Demonstrated experience in a PV leadership role with strong operational and strategic components.
- Demonstrated ability to prioritize multiple tasks and deliver to deadline with high standard of quality.
- Expert evaluation skills and analytical thinking.
- Strong communication skills and able to thrive in a dynamic environment
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 Blue Cross Blue Shield 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.