Biogensandbox

Biogensandbox

Medical Director, Clinical Development - SMA

Role

Medical Director, Clinical Development - SMA

Job type

Full-time

Posted

83 months ago

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Salary

Not disclosed by employer

Job description

The position of 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 Biogen, external stakeholders in the medical community as well with global regulatory authorities.

The 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
  • Oversee clinical study development, medical monitoring, and data interpretation.

Biogen 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

The position of 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).

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