Aug 08, 2020

Senior Medical Director, Clinical Development, Neurodegeneration Development Unit

  • Professional Diversity Network
  • Cambridge, MA, USA
Pharmaceutical

Job Description

Biogen

Job DescriptionBiogen is unique in its focus on neuroscience, and in particular has a deep and innovative pipeline in Alzheimer's disease, dementias and movement disorders. The position of Senior Medical Director, Alzheimer's disease and dementias for Clinical Development sits in the Neurodegeneration Development Unit (NDU) - a component of the Research and Early Development organization charged with all phases from Ph1 clinical trials through to registration. The Senior Medical Director is a member of NDU Leadership Team and will join a group of talented clinical development specialists focused on both Alzheimer's disease, dementias and movement disorders and reporting to a single Senior Vice President.The successful candidate will play a key role in advancing the current Alzheimer's disease and dementias pipeline and in enriching and expanding its scope. Through their responsibility for multiple clinical programs, they will drive innovation in clinical study design and endpoints, actively participate in development of biomarker strategies, and oversee the interpretation of data from key clinical studies. This will require close collaboration with members of cross-functional teams, modality experts, statistical, biomarker, pharmacology and others in development and beyond, all present on the Cambridge campus. A key opportunity will be to interact with multiple levels of management within Biogen, peers and leaders in companies involved in key collaborations, external stakeholders in the medical and scientific community, along with global regulatory authorities.The Senior Medical Director has the following responsibilities:Provide a strategic and clinical leadership role within the Neurodegeneration Development Unit (NDU).Lead the strategic design, execution, and interpretation of key clinical studies, with a special focus on Alzheimer's Disease and dementia which support high-priority Corporate initiatives.Contribute to growth of the pipeline through identification and diligence of in-licensing opportunitiesAdvise and work closely with the clinical leads and RDPLs in clinical development for Alzheimer's disease and dementia from Ph1 through to filing across the Alzheimer's disease and dementia drug portfolio.Provide strategic leadership for the clinical programs that integrates both the individual's extensive knowledge in the disease area and the medical and advocacy community around that world and the commercial, research, regulatory, and medical research goals and needs of the corporate activities in the disease area.Represent R&D Development as lead on Alzheimer's disease and dementia Strategy.Line Manager for clinical leads on Alzheimer's disease and dementia portfolio of programs.Interact with multiple levels of management within Biogen as well with regulatory authoritiesOversee development of clinical activities across several drug development studies within a therapeutic area in collaboration with the clinical development teams.Integrate the scientific rationale, regulatory requirements, product development plan, and commercial goals to build a solid strategic framework for the Clinical Development Plan (CDP).Lead strategic initiatives and clinical program team(s), including Medical Directors, Clinical Program Leaders (CPLs) and / or Clinical Scientists and Clinical Trial Managers (CTMs).Manage clinical program budget(s) within stated financial goals.Develop and maintain relationships with program counterparts in Global Clinical Operations (GCO), Biostatistics, Commercial, Research, Regulatory, and Medical Affairs.Represent clinical development at FDA, CHMP, PMDA and other regulatory agencies.As required, establish external collaborative relationships to augment internal Biogen capabilities in support of early-phase development programs.Contribute to the development of strategic initiatives, specific Business Development activities and overall lead various organizational initiatives in Clinical Development.#LI-NM1Qualifications8+ years of overall relevant experience within pharmaceutical/biotech industry or academic medicinePrevious leadership experience leading direct teams and through a matrix environmentDrug development expertise including clinical development planning and biomarker strategyAbility to drive swift decisions involving numerous stakeholdersAbility to communicate effectively at all levels and present complex and/or new ideas with clarity and simplicityAble to facilitate discussions among groups with diverse technical expertise and drive decisions on complex issuesExperience in Alzheimer's disease, Dementia and or Movement disorders preferred but not requiredEducation: PhD, MD or MD/PhDAdditional InformationBiogen is unique in its focus on neuroscience, and in particular has a deep and innovative pipeline in Alzheimer's disease, dementias and movement disorders. The position of Senior Medical Director, Alzheimer's disease and dementias for Clinical Development sits in the Neurodegeneration Development Unit (NDU) - a component of the Research and Early Development organization charged with all phases from Ph1 clinical trials through to registration. The Senior Medical Director is a member of NDU Leadership Team and will join a group of talented clinical development specialists focused on both Alzheimer's disease, dementias and movement disorders and reporting to a single Senior Vice President.PDN-25a9717a-7d05-4f60-ac95-cc48ca3dcaf5

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