Senior Manager, Clinical Startup Strategist
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. We also have programs targeting the treatment of chronic hepatitis B, children with autism and serious GI symptoms, as well as two programs partnered with Takeda Pharmaceuticals targeting inflammatory bowel disease.
Reporting to our Clinical Site Liaison Director, the Clinical Startup Strategist (CSS) is responsible for study startup deliverables for assigned studies that are of moderate to high complexity. The CSS partners with the Clinical Project Manager, Clinical Site Liaison, Site Operations, CRO representatives, and others as required. This role provides strategic planning and organization skills to ensure the delivery of operational startup aspects of one or more studies, accelerated start up strategies are leveraged, and align all country and site activities to Start Up Project Plan. You will also be accountable for startup and site activation plans, institutional review board/ethics commitee and regulatory authority submissions, and resolution of site activation escalations, including offering options for mitigation (both at the study and site level).
- Working proactively and in close collaboration with Finch/CRO clinical study teams, the CSS will perform study activities, including but not limited to the following:
- Leader of Site Activation strategy and act as a core member of the Study Management Team (SMT).
- Lead the cross functional site activation team – internal plus external as applicable, while utilizing the appropriate team members to support implementation of the Start Up Project plan
- Ensure accelerated Startup for all sites
- Resolve escalated issues identified in partnership with the Clinical Project Manager and Clinical Site Liaisons.
- Accountable for defining, developing, and delivery of the Global Study Start Up Project Plan, including Track and communicate with Study Management Team
- Promptly recognize and remediate potential delays, and escalate non-performance as needed
- Manage CRO partner to drive the Startup site activation timelines across all sites to the level of the individual site: Understanding critical path activities at the site level
- Ensure site readiness activities are considered in the overall timelines for each site in partnership with CRO partner
- Leverage all available intelligence to inform the Study Startup Strategy
- Identify risks to site activation and develop mitigation plans, including providing input to SMT materials
- Identify, communicate, and implement lessons learned across sites, regions, and studies
- Bachelor’s degree (health sciences or related field preferred).
- Minimum 5+ years clinical research experience in pharmaceutical or biotechnology field, including clinical monitoring and clinical operations study management experience in the biotech/pharmaceutical industry
- Demonstrated knowledge of site selection, site activation, site readiness interdependencies
- Technical expertise in the use of Site Activation tools
- Strong vendor management skills
- Experience building effective relationships with customers and other stakeholders
- Demonstrated ability to introduce new ideas and implement them
- Strong written and verbal communication skills; effective collaboration, interpersonal and organizational skills
- Knowledge of local and FDA regulatory requirements and ICH GCPs
- Demonstrated skills in motivating and integrating project teams
- Discerns relevancy of problems; explores options and arrives at solutions that correct situations
- Proficient with Microsoft Office
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 generous 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 (temporarily closed due to COVID), fully stocked kitchen with free snacks, iced coffee & flavored/sparkling waters on tap. 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.