Associate / Medical Director, Clinical Development, Multiple Sclerosis at Biogen in Cambridge, Massachusetts

Posted in Pharmaceutical 4 days ago.

Type: Full Time





Job Description:

Job DescriptionThe (Associate) Medical Director, Clinical Development will focus on Multiple Sclerosis related activities in the MSDevelopment Unit (DU). Activities include direct responsibility for advancing clinical development assets (phase 1 to phase 3 stage) and/or multiple high priority label-enabling clinical programs through clinical study design and execution as well as interpretation and communication of study data. They will also assist the early research team in transitioning molecules from research to clinical development. 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.This role is ideally based in Cambridge, MA, USA. (Potential to sit withinBaar, Switzerland.)Responsibilities: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 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.Who You AreYou are a proven leader within the Clinical Development, Neurology space and strive on developing, executing and advancing a strategic and successful development program. You have experience working within high performing teams; providing the necessary guidance and mentoring for all to reach their goals.#LI-NM1QualificationsBiogen is excited to add depth to their MS Clinical Development team. The ideal candidate will have the following mix of professional and personal characteristics:MD, MD/PhD or PhD degree required; sub-specialty training in Neurology, Immunology Neuroscienceis a plus.Three (3) to five (5) years of experience in clinical research with a proven record of achievement.For the Medical Director level: industry experience in drug development is required (3+ years.) Associate Medical Director level will consider candidate with clinical research experience on independent research projects.Demonstrated leadership and team building skills as well as the ability to perform effectively in a multi-disciplinary environment.Excellent communication skills (oral and written) and excellent organizational skills.Capacity and willingness to work effectively across disease areas.The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills.Additional InformationThe (Associate) Medical Director, Clinical Development will focus on Multiple Sclerosis related activities in the MSDevelopment Unit (DU). Activities include direct responsibility for advancing clinical development assets (phase 1 to phase 3 stage) and/or multiple high priority label-enabling clinical programs through clinical study design and execution as well as interpretation and communication of study data. They will also assist the early research team in transitioning molecules from research to clinical development. 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.This role is ideally based in Cambridge, MA, USA. (Potential to sit withinBaar, Switzerland.)PDN-93a1065f-4948-417d-bfc8-f052b7853a56