Medical Director

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Senior Medical Director, Clinical Development, Neurodegeneration Development Unit Company: Biogen

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Senior Medical Director, Clinical Development, NeurodegenerationDevelopment Unit Cambridge, MA

Full-time

Department: Research & Development

Region: US

Job Description Biogen is unique in its focus on neuroscience,and in particular has a deep and innovative pipeline in Alzheimer’sdisease, dementias and movement disorders. The position of SeniorMedical Director, Alzheimer’s disease and dementias for ClinicalDevelopment sits in the Neurodegeneration Development Unit (NDU) –a component of the Research and Early Development organizationcharged with all phases from Ph1 clinical trials through toregistration. The Senior Medical Director is a member of NDULeadership Team and will join a group of talented clinicaldevelopment specialists focused on both Alzheimer’s disease,dementias and movement disorders and reporting to a single SeniorVice President.

The successful candidate will play a key role in advancing thecurrent Alzheimer’s disease and dementias pipeline and in enrichingand expanding its scope. Through their responsibility for multipleclinical programs, they will drive innovation in clinical studydesign and endpoints, actively participate in development ofbiomarker strategies, and oversee the interpretation of data fromkey clinical studies. This will require close collaboration withmembers of cross-functional teams, modality experts, statistical,biomarker, pharmacology and others in development and beyond, allpresent on the Cambridge campus. A key opportunity will be tointeract with multiple levels of management within Biogen, peersand leaders in companies involved in key collaborations, externalstakeholders in the medical and scientific community, along withglobal regulatory authorities.

The Senior Medical Director has the followingresponsibilities:

Provide a strategic and clinical leadership role within theNeurodegeneration Development Unit (NDU).

Lead the strategic design, execution, and interpretation of keyclinical studies, with a special focus on Alzheimer’s Disease anddementia which support high-priority Corporate initiatives.

Contribute to growth of the pipeline through identification anddiligence of in-licensing opportunities

Advise and work closely with the clinical leads and RDPLs inclinical development for Alzheimer’s disease and dementia from Ph1through to filing across the Alzheimer’s disease and dementia drugportfolio.

Provide strategic leadership for the clinical programs thatintegrates both the individual’s extensive knowledge in the diseasearea and the medical and advocacy community around that world andthe commercial, research, regulatory, and medical research goalsand needs of the corporate activities in the disease area.

Represent R&D Development as lead on Alzheimer’s disease anddementia Strategy.

Line Manager for clinical leads on Alzheimer’s disease anddementia portfolio of programs.

Interact with multiple levels of management within Biogen aswell with regulatory authorities

Oversee development of clinical activities across several drugdevelopment studies within a therapeutic area in collaboration withthe clinical development teams.

Integrate the scientific rationale, regulatory requirements,product development plan, and commercial goals to build a solidstrategic 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 financialgoals.

Develop and maintain relationships with program counterparts inGlobal Clinical Operations (GCO), Biostatistics, Commercial,Research, Regulatory, and Medical Affairs.

Represent clinical development at FDA, CHMP, PMDA and otherregulatory agencies.

As required, establish external collaborative relationships toaugment internal Biogen capabilities in support of early-phasedevelopment programs.

Contribute to the development of strategic initiatives, specificBusiness Development activities and overall lead variousorganizational initiatives in Clinical Development.

#LI-NM1 Qualifications 8+ years of overall relevant experiencewithin pharmaceutical/biotech industry or academic medicine

Previous leadership experience leading direct teams and througha matrix environment

Drug development expertise including clinical developmentplanning and biomarker strategy

Ability to drive swift decisions involving numerousstakeholders

Ability to communicate effectively at all levels and presentcomplex and/or new ideas with clarity and simplicity

Able to facilitate discussions among groups with diversetechnical expertise and drive decisions on complex issues

Experience in Alzheimer’s disease, Dementia and or Movementdisorders preferred but not required

Education: PhD, MD or MD/PhD

Additional Information Biogen is unique in its focus onneuroscience, and in particular has a deep and innovative pipelinein Alzheimer’s disease, dementias and movement disorders. Theposition of Senior Medical Director, Alzheimer’s disease anddementias for Clinical Development sits in the NeurodegenerationDevelopment Unit (NDU) – a component of the Research and EarlyDevelopment organization charged with all phases from Ph1 clinicaltrials through to registration. The Senior Medical Director is amember of NDU Leadership Team and will join a group of talentedclinical development specialists focused on both Alzheimer’sdisease, dementias and movement disorders and reporting to a singleSenior Vice President.

Senior Medical Director, Clinical Development, NeurodegenerationDevelopment Unit

Keywords: Biogen, Cambridge , Senior Medical Director, Clinical Development, Neurodegeneration Development Unit, Other , Cambridge, Massachusetts

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