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Sr. Medical Director, Clinical Development - Late Stage Development Lead - United States
Posted on : 28 May 2017
- This position leads and oversees the Clinical Development of registration-stage acute stroke assets.
- The roles is responsible, for each asset, for developing and implementing the Development Strategy for these registrational assets including the design, conduct, interpretation of data from phase 3 studies as well as oversight of clinical pharmacology and pediatric studies as required to fulfill regulatory requirements.
- The individual in this role will have responsibility for identifying, hiring, and supervising 1-2 Associate Medical Directors to support the execution of the Development activities across the Stroke program(s).
- Accountable for the development of the Clinical Development Plan/strategy for each asset reflective of the appropriate balance of risk, scientific rigor, and value to patients and share-holders, and cost. Achieves this both through direct action as well as through the supervision of junior MDs
- Serves as primary interface with internal stake holders as well as external KOLS and Regulatory authorities for assigned programs.
- Accountable for production of highest quality clinical elements of study, program, and Regulatory documents including protocols, IBs, briefing documents, and drug labels.
- Accountable for attracting, retaining, developing and supervising 1-2 Associate / Medical Directors in drug development
- Leads the technical evaluation of business development activities for stroke
At least 7 years in pharmaceutical industry with experience in leading registration-stage trials and significant interaction with global regulatory authorities
MD, or PhD, ideally with training in critical care or neurology
- Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases.
- Our company is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS).
- Our company also manufactures and commercializes biosimilars of advanced biologics.
- Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
- Our company was founded in 1978 and today serves patients in nearly 70 countries.
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