Associate Director, Clinical Operations
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.
Responsible for overseeing the coordination, management, and operational aspects of Clinical Programs to secure the successful completion of projects within prescribed time frame and funding parameters. The successful candidate will be responsible for the planning, implementation and conduct of large, pivotal clinical trials, or responsible for being the operational lead for a product and associated development program. The Associate Director will be expected to provide leadership within the Clinical Operations department and make recommendations with regards to the strategic aspects of clinical programs. Works cross-functionally to identify and evaluate issues in the programs, interprets data on complex issues, make good business decisions and suggests and implements solutions. The Associate Director, with support from the Director, will be accountable for ensuring that all project deliverables meet the corporate and department expectations. The Associate Director is a leadership role in the management, development, and retention of the clinical group. The Associate Director will be responsible for oversight of activities within the Clinical Operations activities including management of CROs and other vendors and oversight for the work product of the group.
This position will report into the Director of Clinical Operations.
Responsibilities / Duties
- Participate as a member of the Clinical Operations Team involved in defining the strategic direction of the clinical development path for various trials
- Manage internal clinical program staff and CROs, ensuring GCP compliance, proper training and staff development as appropriate
- Responsible for ensuring compliance with departmental and company goals
- Lead clinical development activities and process improvement initiatives; is the key individual to communicate updates to all team members involved
- Serve as key contact to other groups outside of Clinical Operations involved and contributing to the operational aspects of clinical trials
- Able to present at departmental, interdepartmental and Investigator meetings/trainings
- Keep up to date with industry practice and communicates key message back to team and provides recommendations accordingly
- Responsible for ensuring that all internal team members and vendors are completing documentation in accordance with GCP regulatory requirements and consistent with the protocol, for all assigned programs/trials
- Ensure internal compliance with SOPs, guidelines and corporate compliance policies related to the clinical trial conduct aspects of GCPs and other applicable regulations
- Expected to lead direct reports, and is responsible for ensuring and overseeing the work of others including mentoring of staff on all assigned projects
- Actively participate in the departmental goal setting and ensures individual goals align with the overall corporate goals
Establish Operational Objectives and Assignments within Clinical Lifestyle Plan
- Assist in the development of short- and long-term objectives for clinical programs
- Oversee Management of the Clinical Lifecycle Plan for relevant programs in keeping with corporate and department goals
- Participate in the design and development of clinical trial protocols and study specific documents e.g., informed consent forms, study guidelines, operations manuals
- Oversee/manage the overall activities of relevant CROs, and other vendors
- Act as resource for project teams in assigned area(s)
Contribute to Overall Program Strategy and Direction
- Work on complex program issues in which analysis of situations or data require in depth evaluation of various factors, and thoughtfully escalates concerns to Senior Management, as appropriate
- Exercise a leadership role in preparation and review of clinical development plan with an emphasis on strategic planning for assigned programs
- In collaboration with Director, prepare information for senior management meetings, and prepare context and proposed solutions regarding gaiting events for programs
- Chair or participate in department and cross-functional meetings
- Involved in defining the strategic direction of the clinical development path for various trials
Development and Oversight of Program Budgets
- Oversee and manage program specific budget in conjunction with Manager of Operations
- Facilitate the development of clinical trial agreements and other relevant documents; review and approve site budgets
- Oversee review and approval of CRO and other vendor budget and SOWs and change orders
- Oversee the evaluation of potential clinical investigators and sites
- Direct development of study plans and priorities
- Analyze and develop action plans to address protocol compliance, safety, data integrity and administrative issues with investigational sites, CROs and vendors
- Oversee and assist with the development of the clinical components of regulatory submissions
Provide mentoring, Leadership and Guidance/Process Improvement
- Manage the progress of oversight of activities of relevant CROs and vendors
- Provide oversight and direction for clinical operations team
- Assume Leadership role in identifying and implementing training for study staff and direct reports
- Lead development of initiatives that improve the overall management of studies and programs and personnel development at Finch
- Participate in modification and execution of company policies that affect immediate clinical operations, and may have company-wide effect
- Bachelors degree (health sciences or related field preferred); Master’s preferred.
- Minimum 7+ years clinical research experience in pharmaceutical or biotechnology field
- Minimum 2 years project management experience in clinical research environment including leading and/or managing staff directly
- 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
- Computer skills: Proficient with Microsoft Office
Skills and Competencies
- Strong knowledge of GCP/ICH and FDA regulatory requirements and excellent organizational ability
- Excellent oral, presentation, and written communication skills
- Strong knowledge of clinical drug development process, clinical study design and planning
- Proven time management, project management skills and leadership ability
- Demonstrated budgeting, forecasting and fiscal management skills
- Demonstrate excellent leadership skills with ability to supervise
- Demonstrated record of proficient project management skills
- 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 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