As a Medical Director you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Medical Director, Clinical Development Sciences Hematology may lead the clinical sub-team or support the clinical sub-team and the global program team to build global clinical development plans and contributes to the development of asset level and therapeutic area strategies. Responsible for overseeing the clinical development strategy development and execution for 1 program, leading the clinical subteam, contributing to the development of regulatory strategy, and representing the clinical program at regulatory meetings
Responsibilities
* Lead or support the clinical subteam and oversee the design and execution of multiple clinical studies or clinical programs.
* Represent Clinical Development on the Global Program Team and in presentations at management and review committees.
* Functionally, supervise and develop medical monitors and / or clinical development scientists, if any and as assigned by the manager.
* Lead one or more clinical study teams in the preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents, as assigned by manager.
* Development of medical content for regulatory document, and responses (including but not limited to NDAs / BLAs, sNDAs / SBLAs, briefing packages and common technical documents)
* Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans, and therapeutic area strategy.
* Serve as the Medical input to the Global Development Team / Subteam and the Medical Expert for clinical study team.
Qualifications
* Physician with MD or foreign equivalent; PhD nice to have
* 5-10 years of clinical development experience preferably within industry
* 3-5 years minimum experience as a medical monitor for clinical trials required
* Regulatory experience required
* Track record of publication in peer reviewed journals, preferably first-authored publications
* Advanced knowledge of the assigned therapy area (hematology) is desired, with the capability to interpret, discuss and represent trial or program level data.
* 5+ years of industry experience in clinical development is preferred
* Experience for medical responsibilities on a cross-functional team preferred
* Experience authoring study essential documents, Clinical Study Reports, and regulatory documents
LI-NR1
J-18808-Ljbffr
#J-18808-Ljbffr