Non-Clinical Development Director

Non-Clinical Development Director

GENFIT

Lille or Zurich

The Non-Clinical Development Director will lead the pre-clinical activities to efficiently pivot GENFIT’s R&D programs into clinical stage and support the development of disease-modifying drug candidates through to registration. They will play a critical role working closely with a cross-functional asset team to drive the preclinical development strategy, design, execute filing studies and manage third party vendors. The Non-Clinical Development Director reports to the Chief Technology Officer.

MISSIONS:

Your responsibilities include, but are not limited to:

• Devise the non-clinical strategy across GENFIT’s programs;
• Lead the development, planning and execution of non-clinical studies (GLP and non-GLP), including safety pharmacology and toxicology (including genotoxicity) and bridging efficacy studies;
• Lead the screening, evaluation, and oversight of contract research organizations (CROs) and other external providers to monitor their overall performance;
• Lead and contribute to the protocol design, data analysis and interpretation and report writing of all non-clinical studies;
• Ensure all non-clinical projects are completed, on time, within budget and in accordance with regulatory and scientific standards both internally and at third party vendors;
• Write non-clinical and safety sections for regulatory documents;
• Act as the non-clinical Subject Matter Expert (i.e. toxicology, PK, ADME, DMPK) in support of the project teams in a highly cross functional and collaborative manner to inform decision making for CMC, early stage clinical study design, Global Development Plans, and regulatory interactions;
• Author relevant non-clinical sections of internal and regulatory documents including but not limited to protocols, Investigational New Drug Application (IND), Clinical Trial Application (CTA), investigator brochure, New Drug Application (NDA);
• Prepare scientific presentations relevant to both internal and external communications;
• Contribute to writing scientific communications including publications;
• Develop and maintain relationships with relevant scientific and clinical partners, key opinion leaders, etc.

PROFILE:

• You hold a PhD (preferred) or MSc (required) in biology, toxicology or relevant training in pharmaceutical sciences, clinical pharmacology or biological sciences;
• You possess relevant practical work experience of at least 8 years in a similar role dealing with non-clinical safety, toxicity, ADME, DMPK and PK/PD studies with novel therapeutic entities;
• A self-starter, you have demonstrated excellent planning and project management skills, with the ability to thrive in a fast-paced organization and to deal with shifting priorities, demands, and timelines;
• You have knowledge of GLP compliance and relevant ICH & FDA guidance documents;
• You have experience with CTA, IND and MAA/NDA filings and a thorough knowledge of relevant EMA and FDA regulations;
• You are able to effectively manage a team of scientists and collaborate across multiple work streams;
• You are able to manage external CROs and collaborators with high professionalism;
• You are able to manage assigned development budget including forecasting and planning;
• You have experience in managing risks and develop risk mitigation plans;
• You have a verifiable track record of writing or publishing scientific research;
• You show excellent communication skills and master written and oral presentations in English with internal and external stakeholders in an international environment;
• You have the autonomy, flexibility and adaptability to work in a biotech company.

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