Medical Director, Clinical Development, Neuromuscular Disorders

Biogen SANDBOX • Cambridge, MA

5d

About The Position

The appropriate candidate will have to opportunity be a key leader across multiple early stage assets and/or therapeutic areas. 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, key external stakeholders in the medical and scientific community, along with global regulatory authorities. The Medical Director has the following responsibilities:

Provide strategic leadership for programs that integrate the individual’s extensive knowledge in basic and clinical science, neurology disease areas with knowledge from the medical community around the world.

Execute an early stage development program in ALS or other nerve and muscle disease areas.

Integrate the scientific rationale, regulatory and payor requirements, input and advice from medical and patient advocacy groups, 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 each CDP.

Develop and maintain relationships with program counterparts in Commercial, Research, Regulatory, Biomarkers, Clinical Operations and Statistics.

As required, establish external collaborative relationships to augment internal Biogen capabilities in support of early-phase development programs Contribute to the development of strategic initiatives and specified Business Development activities. #LI-RD3 Qualifications The ideal candidate will have the following mix of professional and personal characteristics:

The position of Medical Director, Clinical Development sits in the Neuromuscular Therapeutic Area – a component of the Research and Early Clinical Development Organization. The Medical Director will support one or more development programs involving products in ALS or other neuromuscular disease. The initial focus will be in designing and executing clinical trials in early development.

Requirements

• At least three (3) years of experience in clinical research

Nice To Haves

• Industry experience in clinical development preferred, but not strictly required.

Responsibilities

• Provide strategic leadership for programs that integrate the individual’s extensive knowledge in basic and clinical science, neurology disease areas with knowledge from the medical community around the world.
• Execute an early stage development program in ALS or other nerve and muscle disease areas.
• Integrate the scientific rationale, regulatory and payor requirements, input and advice from medical and patient advocacy groups, 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 each CDP.
• Develop and maintain relationships with program counterparts in Commercial, Research, Regulatory, Biomarkers, Clinical Operations and Statistics.
• As required, establish external collaborative relationships to augment internal Biogen capabilities in support of early-phase development programs Contribute to the development of strategic initiatives and specified Business Development activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed
• Number of Employees: 1,001-5,000 employees