Director, Clinical Site Liaison

About Finch

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.

 

Position Summary
The Clinical Site Liaison (CSL) will serve as a field-based, site-facing resource and extension of Clinical Operations in support of assigned Finch clinical development programs. The CSL will serve as an interface between Finch, clinical study site personnel, and vendors to ensure quality and timely study execution at the site level. The CSL will be responsible for cultivating and fostering long-term relationships with clinical trial investigators/study site personnel to help position Finch as a sponsor of choice. In addition, the CSL will support the effective CRO interactions with study sites by developing relationships with key CRO personnel and supporting the development of effective processes and communication between the CRO and Finch as well as the CRO and investigator sites.

This position will report into the Senior Director of Clinical Operations.

Responsibilities / Duties

• Working proactively and in close collaboration with Finch/CRO clinical study teams, the CSL will perform study activities, including but not limited to the following:
• Develop patient recruitment and retention initiatives; ensure full leveraging of recruitment and retention tactics by CROs and clinical sites
• Identify and proactively mitigate challenges related to protocol conduct at study sites; strategically reviews protocols to ensure operational clarity for investigator sites; collaborates with the Study Management Team to develop the baseline timelines and milestones
• Engage study site personnel (i.e., Principle Investigator, Sub-Investigators, study coordinators, other HCPs, etc.) in discussions to:
• maintain focus on overall study design, rationale, and eligibility criteria
• identify operational hurdles/challenges and offer potential strategic solutions; apply mitigations broadly between sites and across studies
• ensure quality execution of clinical studies
• Participate in SIVs and attend other study visits with CRO CRA; may visit investigator sites without CRO personnel
• Help facilitate investigator meetings especially related to local considerations and relationship building with the site personnel and CRO
• Collaborate and align with study MDs, Finch cross functional team members on clinical investigator engagement
• Participate in Finch and CRO meetings
• cross-functional area operational team meetings (i.e., Study Management Team)
• Leverage insight/trends across the Finch portfolio
• Address issues with data collection, management, protocol execution, etc.
• CRO CRA calls (help identify needs-based site support, identify issues/trends requiring proactive mitigation and/or escalation, and to provide ad hoc study-related training as needed)
• periodic 1:1 calls with CRO CRA Manager
• Conduct and document Finch monitoring oversight activities
• Identify and develop needed internal procedures; delineate and communicate responsibility divisions across adjacent roles (i.e., CRO CRA, Finch study lead); identify key performance indicators applicable to this role
• Identify, communicate, and implement lessons learned across sites, regions, and studies

 

Qualifications
• Bachelor’s degree (health sciences or related field preferred)
• Minimum 10+ years clinical research experience in pharmaceutical or biotechnology field
• 8+ years of combined clinical monitoring and clinical operations study management experience in the biotech/pharmaceutical industry
• Strong ability to communicate both oral and written clinical information
• Proven ability to manage vendors
• Ability to work effectively on cross functional teams
• Proven business acumen
• Proficient with Microsoft Office

 

Skills and Competencies
• Ability to develop robust knowledge of protocol, program goals, disease area, competitive landscape
• Ability to convey scientific and medical information to a diverse audience; ability to translate clinical research objectives to strong and clear operational plans
• Strong vendor management skills; experience developing/implementing processes and performance indicators
• Strong written and verbal communication skills; effective collaboration, interpersonal and organizational skills
• Ability to resolve issues independently but escalating, where necessary; mature stakeholder management skills
• Relevant clinical experience and scientific degree/background
• Knowledge of local and FDA regulatory requirements and ICH GCPs
• Demonstrated skills in motivating and integrating project teams
• Strong teaching and mentoring skills
• Discerns relevancy of problems; explores options and arrives at solutions that correct situations
• Able to set appropriate priorities for action, assess the effect of the decision, solution, or action accurately
• Passion, humility, and excitement for doing whatever it takes to drive research forward toward a goal of helping patients with unmet medical needs

 

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 a 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. Once reopened, 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.

 

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.

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