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The Associate Medical Director, Clinical Development will focus on MS-related activities in the MSDevelopment Unit (DU). The candidate will have demonstrated an ability to function successfully in a multidisciplinary team environment; as well as to support and execute independent projects as needed.
Activities include direct responsibility for advancing clinical development assets (phase 1 to phase 3 stage) and/or multiple high priority label-enabling clinical programs through clinical study design and execution as well as interpretation and communication of the study data. The individual who assumes this position will interact with multiple levels of management within Biogen, external stakeholders in the medical community as well as with global regulatory authorities.
Responsibilities:
· Provide medical and strategic leadership for multiple programs that integrate the individual’s extensive knowledge in basic and clinical science, neurology, and input from the medical community around the world.
· Integrate the scientific rationale, regulatory requirements, product development plan, and commercial goals to build a solid strategic framework for the Clinical Development Plan (CDP).
· Establish appropriately aggressive clinical development timelines, incorporating key decision points and Go/No Go criteria for the CDP.
· Gain approval from internal governance and advisory committees for CDP and study protocols.
· Represent Clinical Development on the cross-functional Product Development and Commercialization (PDC) Team and develop and maintain effective relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics.
· Contribute to the development of strategic initiatives, specific Business Development activities and various organizational initiatives in Clinical Development.
· As appropriate, may serve as R&D Project Leader (RDPL) for specific projects
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Biogen is excited to add depth to their MS Clinical Development team. The ideal candidate will have the following mix of professional and personal characteristics:
· Three (3) to five (5) years of experience in clinical research with a proven record of achievement. Industry experience is strongly preferred although candidates withclinical research experience onindependentresearch projects in other settings will be considered.
· Demonstrated leadership and team building skills as well as the ability to perform effectively in a multi-disciplinary environment.
· Excellent communication skills (oral and written) and excellent organizational skills.
· Capacity and willingness to work effectively across disease areas.
· The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills.
Education: MD or PhD degree required; sub-specialty training in Neurology or Immunology is a plus
All your information will be kept confidential according to EEO guidelines.
