Medical Director, Clinical Development, Immunology
Posted on: 18 Jan 2021
Cambridge, MA
Job Description
Job Description
The Medical Director, Clinical Development, Immunology, will lead and oversee the clinical development of assigned immunology assets. Reporting to the Executive Director, Clinical Development, Immunology, the position is responsible for the development and implementation of the Clinical Development Strategy for the assigned assets, including clinical study design and execution, as well as interpretation of study data. The individual in this role will interact with multiple functions and management within Biogen, and with external stakeholders including the global medical expert community, global regulatory authorities and vendors.
The Medical Director will have the following responsibilities:
* Provide medical and strategic leadership for programs that integrate extensive knowledge in clinical science and immunology, and inputs from the global medical community
* Integrates scientific rationale, regulatory requirements, product development plan, and value to patients and shareholders to build a solid strategic framework for the Clinical Development Plan (CDP)
* Establishes appropriate clinical development timelines, incorporating key decision points for the CDP
* Accountable for production of highest quality program related documents, including protocols, IBs, clinical study reports, briefing documents and drug labels
* Develops and maintains relationships with program counterparts in Commercial, Research, Early Clinical development, Regulatory, Clinical Operations and Statistics
* Acts as the primary Clinical Development interface with internal stake holders as well as external KOLS and regulatory authorities for the assigned programs
* Contributes to the development of strategic initiatives, specific Business Development activities and various organizational initiatives in Clinical Development
LI-NM1
Qualifications
Education: MD, and/or PhD, ideally focused in dermatology, rheumatology or immunology
The ideal candidate will have the following professional and personal characteristics:
* Minimum 5 years of experience in leading clinical development programs in the pharmaceutical industry with a proven record of achievements
* Significant interaction with global regulatory authorities
* Demonstrated leadership and team building skills as well as the ability to perform effectively in a multi-disciplinary environment
* The ability to lead directly and by influence, including strong problem solving, conflict resolution and analytical skills in a matrix environment
* Excellent communication skills (oral and written) and excellent organizational skills
* Experience in business development (due diligence) is preferred
Additional Information
The Medical Director, Clinical Development, Immunology is responsible for the development and implementation of the Clinical Development Strategy for the assigned assets, including clinical study design and execution, as well as interpretation of study data.
Biogen
Cambridge, MA
Biogen Inc. discovers, develops, manufactures, and delivers therapies for treating neurological and neurodegenerative diseases worldwide. The company offers TECFIDERA, AVONEX, PLEGRIDY, TYSABRI, and FAMPYRA for the treatment of multiple sclerosis (MS); SPINRAZA for the treatment of spinal muscular atrophy; and FUMADERM for the treatment of plaque psoriasis. It also provides BENEPALI, an etanercept biosimilar referencing ENBREL; FLIXABI, an infliximab biosimilar referencing REMICADE; and IMRALDI, an adalimumab biosimilar referencing HUMIRA. In addition, the company offers RITUXAN for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia (CLL), rheumatoid arthritis, two forms of ANCA-associated vasculitis, and pemphigus vulgaris; RITUXAN HYCELA for non-Hodgkin's lymphoma and CLL; GAZYVA to treat CLL and follicular lymphoma; and OCREVUS for the treatment of primary progressive MS and relapsing MS, and other anti-CD20 therapies.
Further, it is involved in developing BIIB098, Opicinumab, and BIIB061 for MS and neuroimmunology; Aducanumab, Elenbecestat, BAN2401, BIIB092, BIIB076, and BIIB080 to treat Alzheimer's disease and dementia; BIIB092 and BIIB054 for treating Parkinson's disease and movement disorders; BIIB067, BIIB078, and BIIB110 to treat neuromuscular disorders; BIIB093, TMS-007, and Natalizumab to treat acute neurology; BIIB104 for treating neurocognitive disorders; BIIB074 and BIIB095 for pain; and Dapirolzumab pegol, BG00011, and BIIB059 for treating other diseases, which are under various stages of development.
The company offers products through its sales force and marketing groups. Biogen Inc. has collaboration agreements with Genentech, Inc., Eisai Co., Ltd., Alkermes Pharma Ireland Limited, Bristol-Myers Squibb Company, Acorda Therapeutics, Inc., AbbVie Inc., C4 Therapeutics, University of Pennsylvania, Applied Genetic Technologies Corporation, and others. The company was founded in 1978 and is headquartered in Cambridge, Massachusetts.
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IndustryBiotechnology
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No. of Employees7,800
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Website
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Jobs Posted445
