Our client is a major biotech group which is developing best in class drugs for a range of Cardio-vascular illnesses. They are building a clinical development team in the Boston area to handle late phase clinical trials. The Senior Medical Director will be leading key assets from clinical design to preparation for commercialization.
The Role: The Senior Medical Director, Clinical Development Sciences may lead the clinical sub-team or support the clinical sub-team and the global program team to build global clinical development plans and contribute to the development of asset level and therapeutic area strategies.
You will be responsible for: Lead or support the clinical team and oversee the design and execution of multiple clinical studies or clinical programs.Supervise and develop medical monitors and/or clinical development scientists.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.Develop medical content for regulatory documents, and responses (including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages, and common technical documents).Determine appropriate external experts for advisory boards, steering committees, adjudication committees, and/or data monitoring committees, and lead the team in preparation for meetings.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.Conduct medical monitoring activities during periods of vacations, team restructuring, team departures, or in other situations.Lead the presentation of clinical trial related information/data to senior management, as assigned by the manager.Liaise internally with other members of the clinical development team to drive overall program strategy and development plans. Represent Clinical Development at the Global Program Team.Lead Pediatric Program Design and Execution.You will need to have: Physician with MD or foreign equivalent.5-10 years of clinical development experience preferably within the industry.3-5 years minimum experience as a medical monitor for clinical trials required.The company will offer an excellent salary and bonus together with an industry leading stock option program. This is an excellent entry point into a major pharma company which has a truly exciting Cardio-vascular program.
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