Associate/ Medical Director, Clinical Development - Epilepsy & Neurodevelopment

Job Description

The position of Associate/Medical Director, Clinical Development will focus on epilepsy and neurodevelopment related assets and activities. The successful candidate will understand critical disease areas of high unmet need requiring potentially transformative intervention. The candidate will have demonstrated an ability to develop and execute independent research, support and/or lead clinical development teams, and flexibility to function successfully in a multidisciplinary team environment. Activities include direct responsibility for advancing translational programs, particularly in rare diseases. 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.

• Provide medical and strategic leadership for programs that integrate the individual’s extensive knowledge in basic and clinical science, neuroscience, neurology, and input from the medical community around the world.
• Liaise effectually with biologists and pre-clinical scientists to inform strategic target priorities that align Biogen’s known platform strengths with diseases of high unmet need. Create clinical plans that inform Research-to-Development decision-making.
• Integrate the scientific rationale, pre-clinical toxicology and other regulatory requirements, and asset development plans aligned to commercial goals to build a solid strategic framework for the Integrated Development Plan (IDP)
• Have a critical understanding of phase 1 through 3 studies including precise designs of proof-of-concept studies. Establish appropriately aggressive clinical development timelines incorporating key decision points and Go/No Go criteria for the CDPs.
• Develop and maintain relationships with cross-functional program counterparts in focused on planning and execution of clinical studies, and program/asset level teams (e.g., Research, Regulatory, Clinical Operations, Drug Safety, Statistics, Pharmacology, Program Leadership, Medical Affairs, Value and Access and Commercial). As team leader, promote healthy, respectful, and productive culture among team members, and develop others.
• Contribute to the development of strategic initiatives, specific Business Development external diligence activities pertaining to epilepsy and neurodevelopment and various organizational initiatives in Clinical Development and potentially the broader R&D community.

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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 Neurology and Epilepsy is a plus.
• Three (3) to five (5) years of experience in clinical and/or translational research with a proven record of achievement on independent research projects. Industry experience is a plus.
• 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 position of Associate/Medical Director, Clinical Development will focus on epilepsy and neurodevelopment related assets and activities. The successful candidate will understand critical disease areas of high unmet need requiring potentially transformative intervention. The candidate will have demonstrated an ability to develop and execute independent research, support and/or lead clinical development teams, and flexibility to function successfully in a multidisciplinary team environment.