- 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.
- MD or PhD degree required; sub-specialty training in Neurology or Immunology is a plus
- 3+ years industry experience in drug development or related roles to life cycle management of late stage clinical assets with direct experience of regulatory interactions
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Medical Director Clinical Development, Multiple Sclerosis - Cambridge, United States - Biogen
Description
Job Description
Job DescriptionJob DescriptionAbout 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:
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.
QualificationsRequired Skills:
#TD-1
Additional InformationWhy Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
