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Biogen

Develops therapies for neurological disorders

Associate Medical Director - Multiple Teams

Biology & BiotechConfirmed live in the last 24 hours
Full-timeCambridge, MA, USA

About the Job

Requirements

  • An MD, PharmD, and/or PhD, with approximately 5 years of relevant clinical research experience in industry, academia, or a related setting.
  • Hands-on experience with protocol development and implementation, medical monitoring, clinical data review, safety and efficacy interpretation, and preparation of clinical or regulatory documents.
  • Working knowledge of Good Clinical Practice (GCP), clinical trial design and execution, statistical principles relevant to clinical trial interpretation, and regulatory requirements for clinical studies.
  • Strong organizational and project management skills, with the ability to manage competing priorities and deliver high-quality work in a collaborative global matrix environment.
  • Demonstrated success interacting with and building relationships across internal and external stakeholders, including Clinical Operations, Regulatory, Biostatistics, Data Management, Medical Writing, study investigators, and vendors.
  • Strong written and verbal communication skills.

Responsibilities

  • Serve as Study Medical Director for one or more assigned studies, providing day-to-day clinical and scientific oversight from study start-up through conduct, analysis, reporting, and close-out.
  • Support the development of study protocols, protocol amendments, clinical study reports, training materials, regulatory responses, and other key clinical documents.
  • Provide medical monitoring and clinical oversight, including review and interpretation of safety data, efficacy data, clinical data listings, and emerging trends to support participant safety and informed decision-making.
  • Partner with Clinical Operations, Regulatory, Biostatistics, Data Management, Medical Writing, Pharmacovigilance, and other functions to identify clinical, safety, data quality, and operational risks; escalate issues appropriately; and deliver studies with quality and operational rigor.
  • Collaborate with investigators, study sites, vendors, and external experts to support enrollment, protocol adherence, participant safety, and data quality.
  • Contribute to regulatory submissions and health authority interactions, including preparation of clinical content, responses to questions, and presentation materials as needed.
  • Support preparation and execution of investigator meetings, advisory boards, congress presentations, publications, and other scientific communications, as needed.
  • Maintain current knowledge of the therapeutic area, evolving clinical evidence, applicable regulations, and relevant clinical development guidance.

Desired Qualifications

  • Experience in neurology and/or rare diseases.
  • Experience supporting global, multicenter interventional clinical studies.
  • Experience contributing to regulatory submissions, clinical study reports, publications, investigator meetings, or advisory boards.
  • Ability to travel occasionally for scientific meetings, investigator meetings, and clinical site engagement, domestically and internationally, as needed.

About the Company

Biogen

Develops therapies for neurological disorders

Biogen is a global biotechnology company focused on neuroscience. It discovers, develops, and delivers therapies for neurological disorders, such as multiple sclerosis and other neurodegenerative diseases. Its product process starts with research and development to identify potential drugs, followed by clinical testing and regulatory approval, ultimately leading to commercialization and patient treatment. Biogen differentiates itself through a long history (founded in 1978), a deep specialization in neuroscience, and an integrated pipeline that moves ideas from discovery to approved medicines, aiming to create value for shareholders while helping communities. The company’s goal is to advance therapies for neurological diseases to improve patients’ lives and generate sustainable value for stakeholders.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Cambridge, MA
Founded
1978

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