Medical Director Clinical Development, Multiple Sclerosis

4 weeks ago

Cambridge Massachusetts, United States Biogen Full time
Job Description

About the role:

The Medical Director, Clinical Development will focus on Multiple Sclerosis related activities in the MS Development Unit (DU) as they pertain to life cycle management activities of the marketed MS portfolio. Activities will include the support of registrational filing activities for geographic expansion, indication expansion and completion of post marketing trial requirements.   While the role will primarily focus on the marketed MS portfolio, there may also be a requirement to support early development assets.  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.

What you’ll do:

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 delivering on the life cycle management needs of the marketed MS portfolio

Actively contribute to global registrational filing activities and interactions with global regulatory authorities, as well as providing an active role in the design and completion post marketing clinical trial activities

Gain approval from internal governance and advisory committees for study protocols. 

Establish appropriately aggressive clinical development timelines with key go/no go decision points in activities of geographic expansion, indication expansion and post marketing clinical trial commitments

Represent Clinical Development on the cross-functional research and development project team (RDPT) for marketed assets and both 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. 

Who you are: 

You are an effective communicator who is able to collaborate with a wide range of stakeholders from a variety of industry disciplines with ease.  You have an ability to assimilate and utilize data into clinical development planning and overall strategy setting. 

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