Medical Director, Clinical Development, Immunology

Biogen Idec Cambridge , MA 02138

Posted 4 weeks ago

Company DescriptionJob Description

The position of Medical Director, Clinical Development, Immunology sits within Biogen's Immunology Therapeutic Clinical Development Unit; part of our Emerging Pipeline Assets. The new Medical Director will support one or more development programs involving products in lupus and / or other autoimmune diseases. They will work in close collaboration with the Senior Medical Director and cross-functional clinical study teams and provide clinical science support for assigned programs in immunology. The initial focus will be in supporting the clinical development plan and clinical trials in early development. Activities include direct responsibility for advancing high priority clinical programs through clinical study design.

The new hire has the following responsibilities:

  • Will report to a more senior member of the immunology clinical team who has direct responsibility for the overall research strategy and clinical and scientific development activities.

  • Will support conceptualization and development of clinical trials in conjunction with multiple functions, including development from inception of trials in new indications.

  • Drive development of protocols for clinical studies.

  • Prepare and/or provide input to clinical study related and other regulatory documents (e.g. CSRs, IBs, PIS/ICFs, SAPs, Data Management Plans, IND, briefing books);

  • Monitor, review and interpret safety and efficacy data of ongoing studies.

  • Act as (clinical science expert) liaison to clinical study teams, CRO's, study sites and others.

  • Participate and represent Clinical/Medical in cross-functional clinical study team meetings; may act as study director.

  • Provide clinical scientific input to business development (e.g. due diligence);

  • Elaborate and integrate the scientific and clinical rationales, regulatory requirements to support building a solid Clinical Development Plan (CDP), including appropriately aggressive clinical development timelines, incorporating key decision points and Go/No Go criteria for each CDP.

  • Must ensure adherence to all requirements of good study conduct and standards of Good Clinical Practice.

  • May interface with key medical experts and represent the team at medical congresses and conferences.

#LI-NM1

Qualifications

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

  • MD and/or PhD required. Immunology training highly preferred.

  • Three (3) to Five (5) years of experience including clinical research in academia and/or of progressive responsibilities in drug development in industry for Principal Clinical Scientist. One (1) to Three (3) years of experience including clinical research in academia, industry experience in clinical development preferred, but not required for Associate Medical Directors.

  • Capacity and willingness to work effectively across disease areas.

  • A proven track record for clinical and scientific leadership in drug development are ideal and industry experience, particularly in development within the disease area (lupus preferred) , is desirable.

  • Demonstrated leadership and team building skills as well as the ability to perform effectively in a dynamic environment.

  • Excellent communication skills (oral and written) and excellent organizational skills.

  • The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills.

  • Proficiency in Excel, Word and PowerPoint.

Additional Information

The position of Medical Director sits within Biogen's Immunology Therapeutic Clinical Development Unit; part of our Emerging Pipeline Assets. The new Medical Director will support one or more development programs involving products in Lupus or other autoimmune diseases. They will work in close collaboration with the Senior Medical Director and cross-functional clinical study teams and provide clinical science support for assigned programs in immunology. The initial focus will be in supporting designing clinical development plan and clinical trials in early development. Activities include direct responsibility for advancing high priority clinical programs through clinical study design.

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Medical Director, Clinical Development, Immunology

Biogen Idec