Medical Director, Clinical Development

The Medical Director will report to the Executive Director, within Clinical Development, and will play a critical role in shaping clinical strategy, collaborating cross-functionally, and engaging with external experts, investigators, and study sites.

This is an exciting opportunity for a physician/physician-scientist with a strong background in neurology and clinical development to help advance innovative therapies for patients.

Key Accountabilities / Core Job Responsibilities:

• Provide clinical leadership on one or more programs, including the development and execution of Clinical Development Plans (CDPs).
• Oversee clinical science aspects of trial design, execution, interpretation, and reporting, with a focus on safety, pharmacodynamics, and efficacy.
• Collaborate cross-functionally with translational, regulatory, statistical, clinical operations, and safety teams to ensure integrated, data-driven development plans.
• Lead the creation of clinical documents, including study protocols, investigator brochures, clinical study reports, and regulatory submissions.
• Conduct and supervise medical monitoring and safety reporting throughout trials.
• Provide medical oversight for adverse event (AE) and serious adverse event (SAE) assessments and follow-up.
• Mentor clinical science team members.
• Interacts with external clinical experts, investigators, and advisory boards to support clinical and translational development.
• Represent Denali and its programs in both internal and external forums.
• Champion a culture of compliance, ethics, patient-centricity, and scientific rigor.

Qualifications/Skills:

• MD or MD-PhD; formal training in neurology is strongly preferred. Subspecialty experience in pediatric neurology, immunology, or genetics is ideal.
• Minimum of 3+ years of post-training clinical development experience in industry or equivalent clinical or academic research experience, preferably in neurology.
• Proven ability to lead cross-functional teams in a biopharmaceutical environment.
• Demonstrated experience in therapeutic trial planning and execution for neurological indications, including FIH and other clinical studies.
• Strong understanding of biomarker-driven strategies and medical monitoring.
• Effective cross-disciplinary collaboration skills.
• Excellent written and verbal communication skills, with strong presentation capabilities.
• Growth mindset.