Director Medical Clinical Development

SEC is exclusively looking for two Directors Medical Clinical Development on behalf of a BioTechnology company located in France. With a highly novel technology to benefit cancer patients, my client is looking for Directors Medical Clinical Development to design and monitor late-stage clinical trials to secure the successful regulatory approval in Europe and in the USA. The role is preferably based in France, but remains open to remote applicant located outside France.

The responsibilities include but are not limited to:
- Driving clinical trial strategy, study design & trial execution by the creation of clinical development plans, executable synopsis and protocol reviews.
- Overseeing the creation of clinical component of key regulatory & registration documents.
- Evaluating drug safety profile
- Reviewing and approving all clinical documents (IB, Protocol, Study Report etc.)
- Leading interaction with health authorities (FDA & EMA), Advisory Board, KOLs, internal stakeholders and acting as medical expert.
- Planning and executing publication and clinical communication strategy.

Key competencies:
Solid clinical development experience in oncology.
Drug development experience from early phase to commercialisation.
Leadership experience in planning, executing, reporting and publishing.
12-15 years of experience in leadership role with solid experience facing FDA & EMA.

To apply, please send your CV at Camille.Sandres@seclifesciences.com or call Camille on +447912307549.