SMA Clinical Development Lead – Study Medical Director

Biogen, Inc.; Cambridge (MA); On-site; USD 194,000 - 267,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Fitness reimbursement

Disability insurance

Paid vacation

Paid holidays

Sick time

Parental leave

401(k)

Employee stock purchase plan

Tuition reimbursement

Job summary

Biogen, Inc. in the United States is seeking an Associate Medical Director to serve as Study Medical Director for SMA-related studies.

The role provides daily clinical and scientific oversight from start-up to close-out, with collaboration across Clinical Operations, Regulatory, Biostatistics, and Medical Writing to ensure data integrity and participant safety. You will contribute to protocol development, clinical study reports, safety reviews, and regulatory responses, while staying current

Qualifications

• 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.

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; elevate 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.

Skills

Protocol development

Medical monitoring

Clinical data review

Safety interpretation

Regulatory documents

Cross-functional collaboration

Education

MD/PhD/PharmD

Job description

Biogen, Inc. in the United States is seeking an Associate Medical Director to serve as Study Medical Director for SMA-related studies.

The role provides daily clinical and scientific oversight from start-up to close-out, with collaboration across Clinical Operations, Regulatory, Biostatistics, and Medical Writing to ensure data integrity and participant safety. You will contribute to protocol development, clinical study reports, safety reviews, and regulatory responses, while staying current