Medical Director, Clinical Development

Denali Therapeutics•South San Francisco, CA

3d•$272,000 - $336,000

About The Position

Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle™ platform. With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, we are advancing toward our goal of delivering effective medicines to transform the lives of people living with neurodegenerative diseases, lysosomal storage disorders and other serious diseases. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. To support our growing pipeline, we are seeking a Medical Director, Clinical Development, to provide clinical leadership for our enzyme replacement programs. The ideal candidate will have experience in neurology or rare disease drug development, including the execution of therapeutic clinical trials. 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.

Requirements

MD or MD-PhD; formal training in neurology is strongly preferred.
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.

Nice To Haves

Subspecialty experience in pediatric neurology, immunology, or genetics is ideal.

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.