Medical Director, Clinical Development

Role: Medical Director, Clinical Development overseeing neurological and rare disease enzyme replacement programs. Primary objectives include shaping clinical strategy, ensuring trial safety and efficacy, and engaging cross-functional teams and external experts. Responsibilities encompass leading clinical trial design, execution, safety monitoring, medical oversight of adverse events, and developing clinical documents such as protocols and regulatory submissions. The role involves collaborating with translational, regulatory, statistical, clinical operations, and safety teams, as well as representing Denali externally. Qualifications: MD or MD-PhD, with preferred training in neurology, and at least 3+ years of post-training clinical development experience, especially in neurology or rare diseases. Proven leadership in cross-functional teams and experience with neurological trial planning (including FIH studies) are required. Skills include expertise in biomarker strategies, medical monitoring, and strong communication. High-value specifics: focus on innovative biologics crossing the blood-brain barrier, early to late-stage neurodegenerative and lysosomal storage disorder therapies, regulatory engagement, and a patient-centric approach. The position reports to the Executive Director, with a focus on advancing pipeline candidates. Work setup: not specified.