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Sr. Medical Director, Clinical Development - Late Stage Development Lead Cambridge United States,  


Posted on : 28 May 2017

Project Description

External Posting TitleSr. Medical Director, Clinical Development - Late Stage Development Lead Job DescriptionThis 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 LocationCambridge, MA, US Job CategoryClinical Development Requisition Number30242BR QualificationsAt least 7 years in pharmaceutical industry with experience in leading registration-stage trials and significant interaction with global regulatory authorities EducationMD, or PhD, ideally with training in critical care or neurology About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies for the treatment of neurodegenerative and rare diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia. Founded in 1978, Biogen is one of the world s oldest independent biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for Alzheimer s Disease, amyotrophic lateral sclerosis (ALS), Parkinson s disease, spinal muscular atrophy and neuropathic pain amongst others.With more than 7,000 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts. Nearest Major Market: Cambridge Nearest Secondary Market: Boston Job Segment: Biotech, Manager, Pharmaceutical, Business Development, Science, Management, Sales, Research

Locations

Cambridge MA US

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