Medical Director, Clinical Development

Denali Therapeutics; South San Francisco (CA); On-site; USD 272,000 - 336,000; Full time

Benefits offered by this job

401k

Healthcare coverage

Job summary

Denali Therapeutics in South San Francisco, CA, seeks a Medical Director, Clinical Development to lead enzyme replacement programs with a neurology/rare disease focus. The role shapes clinical strategy, oversees trial design, safety monitoring, and regulatory interactions, and collaborates with translational, regulatory, clinical operations, and safety teams.

The ideal candidate has an MD or MD-PhD with neurology training, 3+ years in industry clinical development, and proven cross-functional

Qualifications

• 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.

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.

Skills

Cross-functional leadership

Clinical development

Neurology expertise

Medical monitoring

Excellent communication

Biomarker-driven strategy

Regulatory submissions

Education

MD or MD-PhD

Neurology training

Formal neurology training

Job description

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.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.Salary Range: $272,000.00 to $336,000.00 . Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careersThis compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.