Associate Medical Director, Neurology Research and Early Development – Movement Disorders

Biogen SANDBOX•Cambridge, MA

About The Position

We are looking for a Associate Medical Director to play strategic and clinical leadership role within the Research and Early Development (RED) Movement Disorders organization that advances the clinical pipeline. This person will also contribute to growth of the pipeline through identification and diligence of in-licensing opportunities.

Requirements

Have 5 years of experience in clinical or laboratory research
If no direct industry experience - working familiarity with and experience participating as an investigator in industry-sponsored clinical trials

Responsibilities

Provide strategic leadership for assigned clinical programs through integration of o Own clinical and scientific expertise.
Serve as the Medical Lead for one or more assets in development in the Movement Disorders pipeline, with responsibilities as the key subject matter expert on Clinical Development teams, including biology of the disease, overall design and execution of Clinical Development Plans, clinical/strategic appropriateness of each study, and critical details of each study including doses selected and measurement characteristics of endpoints
Integrate strategic inputs from Biogen research, regulatory, clinical research, global medical and commercial functions as well as external sources such as outside medical and scientific experts, patient advocacy groups, etc.
Contribute to the overall quality/integrity of the comprehensive Clinical Development Plan, from first-in-human through Proof of Concept studies, including:
Establishment clear decision points and criteria, in order to drive to successful transition to pivotal clinical trials in support of a defined product profile through the integration of scientific, regulatory, operational, and commercial/reimbursement considerations.
Scientific and operational collaboration in the context of project teams with colleagues from and other functions within the organization (Experimental Medicine, Translational Medicine, Research, Health Outcomes, Commercial, etc) in support of program goals,
As required, establish external collaborative relationships to augment internal Biogen capabilities in support of early-phase development programs
Participate in Engagements with Regulatory agencies Represent clinical development at FDA, EMA, PMDA and other national regulatory agencies Accountable for the quality of the clinical input into regulatory documents vis-à-vis scientific accuracy, clinical relevance, and clarity sufficient to enable strategic goals
Actively survey scientific landscape in biology and clinical science; identify external opportunities for in-licensing and support clinical and scientific diligence.
Lead and contribute to special projects and areas of investigation to support the development and maintenance of the internal and external ecosystems of Movement Disorders drug discovery and development at Biogen