Associate Medical Director, Clinical Development, Rare Neurology (SMA)
About The Position
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.
Requirements
- 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.
Nice To Haves
- 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.
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.
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Manager
