CLINICAL SCIENCES DIRECTOR
Ref.
GF0562
Location
Cambridge (Boston), MA - USA
Contract
Permanent contract
GENFIT is a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases where there is still considerable unmet need.
The Clinical Sciences Director will be responsible for leading the design of clinical studies, contributing to clinical development and overall product development strategies, and overseeing the conduct of clinical programs.
MISSIONS:
Your responsibilities include, but are not limited to:
- Leading working groups to design clinical programs / evidence generation plans and studies in accordance with the product development strategy and clinical development plan. Serving as the lead author for key program and study documents;
- Leading cross-functional teams to develop a clinical development strategy in accordance with the product development strategy;
- Obtaining input from opinion leaders, healthcare providers, investigators, investigational site study staff, patients, and other external stakeholder groups; organizing advisory board meetings;
- Leveraging real world evidence and historic data to help drive decision making;
- Developing options for relevant innovative or non-traditional approaches to clinical research (e.g., virtual trials, adaptive design);
- Performing clinical data reviews, ensuring appropriate input from clinical research physicians and senior clinical research specialist staff;
- Authoring or contributing to the preparation and review of clinical aspects of regulatory documents (e.g., NDA, MAA, IMPD, IND, IB, briefing packages);
- Reviewing key study quality metrics (e.g., patient retention rates, protocol deviations) and determining appropriate actions in conjunction with the study team;
- Assisting with the identification and selection of investigational sites, and supporting the sites throughout the study in close collaboration with the clinical site monitors and study managers;
- Assisting with the identification, selection and training of vendors;
- Assisting with inspection readiness activities for assigned clinical trials;
- Contributing to/participating in the development, review and training for SOPs.
PROFILE:
- Demonstrated leadership and problem-solving skills;
- Strong analytical skills and strategic thinking as applied to clinical program and study design;
- Excellent organizational and oral and written communication skills;
- Knowledge of ICH, GCP;
- Strong computer literacy;
- Previous experience participating in and/or leading cross-functional product development teams;
- Willingness to travel up to 30%;
- Job Type: Full-time;
- At least 10 years of experience in clinical research, including with clinical study design and interacting with investigators and medical experts (required);
- Advanced degree in life sciences (MD, DO, PhD, PharmD, MS, or equivalent) (required);
- Experience in hepatology / metabolic therapeutic area (preferred);
- Excellent written and verbal communication skills including good command of English language (required); knowledge of French or another language is a plus;
- Required work authorization: United States.