GMA Rare Diseases MD EAP and Data Generation
Detail de l'annonce :
As part of the Rare Diseases cross-functional team, the Medical
Director will ensure the design and execution of key medical affairs
programs with a core focus on driving Global Early Access Program and
Evidence Generation activities on an international scale.
MAIN RESPONSIBILITIES AND TASKS
LEAD THE DEVELOPMENT OF THE EARLY ACCESS STRATEGY FOR RARE DISEASES
ASSETS AND DRIVE ITS EXECUTION
* Ensure that key insights / analyses, opportunities and
commercialization challenges are used to design a robust the EA
Strategy and drive its execution, in collaboration with clinical
operations, country medical directors and the cross-functional teams
DRIVE THE DEVELOPMENT OF EVIDENCE GENERATION STRATEGY AND
POST-APPROVAL STUDIES
* Design, communicate and ensure execution of Annual Evidence
Generation Plan based on data gaps analysis, internal and external
insights
* Develop and implement Real-World Data strategy, including
post-approval studies in collaboration with global drug development,
clinical operations, HEOR, country medical directors and the
cross-functional teams
* Work with country/regional Medical Affairs teams to identify data
gaps and evidence generation opportunities
* Define clear guidelines for local medical functions to design local
company sponsored studies (CSS) and assess investigator sponsored
studies (ISS)
EXPERIENCE / QUALIFICATIONS
EXPERIENCES: Strong experience in Global Early Access Program and
Evidence Generation in Rare Diseases. A minimum of 3 years of Global
Medical Affairs experience within the Pharmaceutical/ Biotech
Industry. Demonstrable experience leading Real-World Data projects on
an international scale.
QUALIFICATIONS: Medical Doctor, Pharmacist or higher qualification in
Life Sciences
Dans le cadre de ses recrutements IPSEN s’engage au respect de
l’égalité de traitement des candidats, indépendamment du sexe, de
l’âge, de l'orientation sexuelle, de l'origine ethnique, de la
couleur de la peau, de la nationalité, du handicap ou de
l'appartenance à un syndicat.