Associate Medical Director, Clinical Development, Rare Neurology (SMA)

About This Role The Rare Neurology Development Unit (RNDU) at Biogen is accountable for developing innovative therapies for spinal muscular atrophy (SMA), amyotrophic lateral sclerosis (ALS), and rare movement disorders (RMD), such as Friedreich ataxia (FA) and Huntington’s disease.   As a member of the SMA Clinical Development team, the Associate Medical Director will serve as Study Medical Director for one or more assigned studies, with appropriate oversight, and provide clinical and scientific oversight for assigned study activities across study execution, data review, analysis, reporting, and regulatory deliverables. In close partnership with cross-functional teams, this individual will help ensure participant safety, data integrity, high-quality study execution, and clear medical/scientific decision-making. The Associate Medical Director will report to the Medical Director, SMA Clinical Development. What You’ll Do 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.

You are a hands-on clinical development professional who can quickly assume ownership of assigned studies and contribute meaningfully in a fast-paced, global matrix environment. You bring scientific curiosity, sound clinical judgment, and a collaborative approach to complex study execution. You are comfortable working through ambiguity, making evidence-based recommendations, and engaging cross-functional partners to advance high-quality clinical development in rare neurology and SMA.

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 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.

Experience in neurology