Medical Director, Clinical Development, Ophthalmology

Company: Biogen Idec
Location: Cambridge
Posted on: June 12, 2021

Job Description:

Company DescriptionJob Description

The Medical Director will assist/lead in clinical development activities for Biogen's Ophthalmology programs within Biogen's Therapeutics Development Unit (TDU). Activities include direct responsibility for advancing clinical development assets (phase I-III) through clinical study design and execution as well as interpretation and communication of the study data. 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.

The position of Medical Director, Clinical Development will focus on Biogen's ophthalmology pipeline, specifically focused on retinal diseases - both inherited and acquired. The successful candidate will understand critical disease areas of high unmet need requiring potentially transformative intervention. The candidate will have demonstrated an ability to support and/or lead clinical development teams, and flexibility to function successfully in a multidisciplinary team environment. In addition, the Director will be responsible for clinical study design and execution as well as interpretation of data from high priority clinical studies, including those developed through external business partnerships. The individual who assumes this position will interact with multiple levels of management and with functions across Biogen, external stakeholders in the medical community and with global regulatory authorities.

The Medical Director has the following responsibilities:

• Provide medical and strategic leadership for multiple programs that integrate the individual's extensive knowledge in basic and clinical science, disease area specialization, 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.
• Gain approval from internal governance and advisory committees for CDP and study protocols.
• Represent Clinical Development on the cross-functional Product Development and Commercialization (PDC) Team and 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.
• As appropriate, may serve as R&D Project Leader (RDPL) for specific projects

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Qualifications

The ideal candidate will have the following mix of professional and personal characteristics:

• MD and/or PhD degree required; subspecialty training in Ophthalmology is a plus but not required.
• Three (3) to seven (7) years of experience in clinical research with a proven record of achievement on independent research projects. Industry experience is required for the Medical Director title with a preference for ophthalmology, orphan or rare genetic disease experience.
• Demonstrated leadership and team building skills as well as the ability to perform effectively in a multi-disciplinary, highly matrixed environment.
• Excellent communication skills (oral and written) and excellent organizational skills.
• Capacity and willingness to work effectively across disease areas as needed.
• The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills.
• Must have the ability to travel for site visits, scientific meetings and other business needs.

Additional Information

The Medical Director will assist/lead in clinical development activities for Biogen's Ophthalmology programs within Biogen's Therapeutics Development Unit (TDU). Activities include direct responsibility for advancing clinical development assets (phase I-III) through clinical study design and execution as well as interpretation and communication of the study data.

Keywords: Biogen Idec, Cambridge , Medical Director, Clinical Development, Ophthalmology, Other , Cambridge, Massachusetts