Study Medical Director, SMA & Rare Neurology

Biogen; Cambridge (MA); Presencial; USD 194.000 - 267.000; Jornada completa

Descripción de la vacante

Biogen's Rare Neurology Development Unit is seeking an Associate Medical Director to act as Study Medical Director for SMA trials, delivering day-to-day clinical and scientific oversight from start-up through close-out. The role emphasizes participant safety, data integrity, and global regulatory readiness.

You will collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, and Medical Writing to advance trial execution, monitor safety, interpret data, and support

Formación

• MD, PharmD, and/or PhD with ~5 years of clinical research experience.
• Experience with protocol development and medical monitoring.
• Knowledge of GCP and regulatory requirements for clinical studies.
• Strong organizational and project management skills.
• Proven ability to interact with cross-functional teams and external stakeholders.
• Excellent written and verbal communication skills.

Responsabilidades

• Serve as Study Medical Director for one or more SMA trials, providing day-to-day clinical and scientific oversight.
• Support development of study protocols, amendments, and clinical study reports.
• Provide medical monitoring and safety oversight, including interpretation of safety and efficacy data.
• Collaborate with cross-functional teams to manage risks and deliver high-quality studies.
• Engage investigators, sites, vendors, and external experts to support enrollment and data quality.
• Contribute to regulatory submissions and health authority interactions.
• Support investigator meetings, congress presentations, and publications.

Conocimientos

MD/PhD/PharmD

Clinical research

Protocol development

Medical monitoring

Regulatory submissions

Communication skills

Educación

MD/PhD/PharmD or equivalent

Descripción del empleo

Biogen's Rare Neurology Development Unit is seeking an Associate Medical Director to act as Study Medical Director for SMA trials, delivering day-to-day clinical and scientific oversight from start-up through close-out. The role emphasizes participant safety, data integrity, and global regulatory readiness.

You will collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, and Medical Writing to advance trial execution, monitor safety, interpret data, and support