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MEDICAL DIRECTOR M/F

Fonction : Etudes cliniques / Développement clinique
Publiée le : 28-05-2018
Type de contrat : CDI

Début de mission : 16-04-2018
Temps de travail : Complet

Présentation du poste

You will be the medical lead for one or several assets in clinical development at Innate Pharma.
 
Here are the key missions of the Medical Director :
The Medical Director plays a key role in setting up the clinical development plans for the product(s) he/she is responsible for, within the strategic objectives of the company.

Together with other functions (preclinical, regulatory, etc.), he/she is responsible for the design of clinical studies to be conducted as part of the development plan with particular emphasis on methodology and selection of indications. He/she prepares the study synopses and contributes to the study protocols (including amendments).  When the protocol includes translational aspects (pharmacokinetic, pharmacodynamics, biomarkers, etc), he/she interacts with the preclinical and translational groups.

The Medical Director is the central person for any medical aspect of his/her studies, including

  • the monitoring and interpretation of efficacy and safety data (including the continuous evaluation of the side effects and risks associated with the use of the product (pharmacovigilance/safety);
  • the communication with investigators, experts and national and international leaders; management of advisory boards;
  • contribution to regulatory documents;
  • preparation of reports, presentations and publications of clinical results 

The Medical Director provides competitive intelligence in the therapeutic areas of the program, and contributes to scientific education, internally and externally.

The Medical Director operates at the highest degree of integrity and quality

A medical director with the appropriate level of expertise and experience may manage one or several other medical directors. 

Profil

  • Education: M.D. or MD, PhD 
  • Experience in clinical development for a period of at least 10 years.
  • Experience in the pharmaceutical industry for at least five years
  • Experience in the design and conduct of clinical trials preferably in all phases of clinical development (phase I-IV); experience in early clinical development is required (phase I-II trials). Experience in company and investigators sponsored studies is a plus. Demonstrated experience in the writing of clinical reports, publications and presentations
  • Established understanding of pharmacokinetic and pharmacodynamic activities, including biomarkers
  • Knowledge of the EMEA and FDA regulations and guidelines referring to the product development and the conduct of clinical studies for a period of at least 5 years; established experience of interactions with regulatory authorities.
  • Knowledge in in at least 2 of the following areas: oncology, hematology, and Immunology
  • Excellent communication skills

Location : Marseilles (France)
Travel is an essential requirement of this position.
English and French (written and spoken) are mandatory. The position is based in Marseilles (France).
The position is open to candidates with disabilities.

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