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

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.

Who You Are

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.

Required 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.

Preferred 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.