Medical Director, Early Clinical Development

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.The OpportunityDenali Therapeutics is committed to discovering and developing breakthrough therapies for neurodegenerative diseases. Guided by a deep understanding of the genetics and biology of neurodegeneration-and enhanced brain delivery enabled by our TransportVehicle™ platform-our approach emphasizes biomarker-driven development to address areas of high unmet medical need.To support our growing pipeline, we are seeking a Medical Director, Early Clinical Development, to provide clinical leadership for our neurodegeneration programs. The ideal candidate will have experience in Alzheimer's and/or Parkinson's disease drug development, including first-in-human (FIH) and early-stage trials.The Medical Director will report to the Executive Director, Neurodegeneration Lead within Translational Medicine and Early 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-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.Present clinical strategies and progress to Denali leadership.Collaborate cross-functionally with translational, regulatory, statistical, clinical pharmacology, 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.Partner with Discovery to evaluate and prioritize preclinical targets, offering clinical insights into feasibility and strategy.Mentor and manage clinical science team members.Collaborate with academic and clinical experts to strengthen Denali's scientific leadership.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 Alzheimer's or Parkinson's disease is ideal.2 years of industry experience in neurology or comparable clinical trial experience in an academic settingProven ability to lead cross-functional teams in a biopharmaceutical environment.Demonstrated experience in CDP planning and execution for neurological indications, including FIH and other clinical studies.Strong understanding of biomarker-driven strategies, clinical pharmacology, and quantitative pharmacology.Effective cross-disciplinary collaboration skills.Excellent written and verbal communication skills, with strong presentation capabilities.Track record in people management and mentorship.Experience interacting with regulatory agencies during IND/CTA submissions and clinical development.Willingness to travel 10%-25% of the time.Salary Range: $252,000.00 to $300,000.00 . 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.This 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.