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Job Title: Associate Medical Director/Medical Director, Clinical Development
Job Location: Cambridge, MA
Job Duration: 5 months
The position of Associate Medical Director/Medical Director, Clinical Development sits within Pain, Neuromuscular and Rare Disease of Late Stage Clinical Development. The new Medical Director will support Spinal Muscular Atrophy (SMA). The successful candidate will demonstrate the flexibility and capability to function at a high level across multiple studies. Activities include direct responsibility for advancing high priority clinical programs through clinical study design and execution, development of biomarker strategies, as well as interpretation of data from key clinical studies. The individual who assumes this position will interact with multiple levels of management within Client, external stakeholders in the medical community as well with global regulatory authorities.
The Associate Medical Director/Medical Director has the following responsibilities:
• Provide medical and strategic leadership for 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.
• Develop and maintain 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
Qualifications Client is excited to add depth to their 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.
• Industry experience in clinical development
• Three (3) years of progressive responsibilities in drug development, and a proven track record for clinical and scientific leadership in drug development are ideal.
• Demonstrated leadership and team building skills as well as the ability to perform effectively in a dynamic environment.
• Demonstrated strategic and critical thinking.
• 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.
MD, PhD, or Pharm D degree required; training in Neurology is a plus
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