Director of Scientific Affairs (F/H)

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 Director of Scientific Affairs will contribute to the development of the scientific strategy to support GENFIT diagnostics. They will work closely with colleagues throughout the organization to develop and execute the short and long-term scientific strategy for diagnostic products in development and later, marketed diagnostic products.

MISSIONS:

Responsibilities include, but are not limited to:

Provide diagnostics subject matter expertise within and outside the organization (e.g. scientific congresses…);
Directly contribute to the development of and execution of the scientific strategy related to diagnostics and circulating biomarkers and, more broadly, support the medical strategy from a diagnostics perspective;
Ensure that the Scientifc Affairs Plan is aligned with integrated brand strategies;
Collaborate with internal research teams on diagnostics in development to ensure a real-world perspective on utilization;
Establish and maintain strong working relationships with key external stakeholders (Key Opinion Leaders, medical societies, patient advocacy groups, scientific/clinical/medical stakeholders);
Plan, implement and attend external events, including investigator meetings, conferences/congresses, , Advisory Boards, etc.; develop or adapt internal strategies to reflect the output of external scientific boards;
Contribute to the development of and execution of the scientific communications plan to support scientific needs and core strategy (i.e. planning for medical society presence, writing of abstracts/publications, as appropriate and required);
Lead contact with external laboratory partners for scientific/medical communications;
Provide strategic input and scientific due diligence to M&A and licensing activities, where warranted;
Proactively stay abreast of recent scientific/medical literature relevant to therapeutics areas of interest; awareness of competitors' development activities;
Partner with the Compliance and Legal Departments to ensure that all activities are conducted in a manner that is compliant with GENFIT policies, procedures, and local regulatory/legal requirements.

PROFILE:

MD, PhD or PharmD required with 5+ years of biotech/pharma industry experience;
Experience in diagnostics and metabolic/cholestatic liver disease preferred;
Solid understanding of the US regulations that govern Scientific and Medical Affairs activities as well as detailed knowledge of common local, medical practices and treatment habits;
Advanced understanding of clinical medicine/clinical pharmacology, and associated disciplines (e.g. biostatistics) as well as drug development principles and regulatory pathways for diagnostics;
Demonstrated scientific credibility and ability to communicate scientific results in a fair and well-balanced manner and effectively respond to data queries from customers and/or consultants;
Excellent interpersonal skills, ability to develop important relationships with key internal and external stakeholders;
Possesses strong written and verbal communication skills, and ability to teach and mentor others in the team – ability to use French in a professional setting a plus ;
Able to travel up to 30%.

DIRECTOR OF SCIENTIFIC AFFAIRS