Medical Director, Early Clinical Development

Role Summary

Medical Director, Early Clinical Development providing clinical leadership for neurodegeneration programs with experience in Alzheimer’s and/or Parkinson’s disease drug development, including first-in-human and early-stage trials. Reports to the Executive Director, Neurodegeneration Lead, and collaborates across functions to shape clinical strategy and engage with external experts and study sites.

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‚Äôs 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

• MD or MD-PhD; formal training in neurology strongly preferred. Subspecialty experience in Alzheimer‚Äôs or Parkinson‚Äôs disease ideal.
• 2 years of industry experience in neurology or comparable clinical trial experience in an academic setting.
• Proven 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%‚Äì25% of the time.

Education

• Not specified beyond the MD/MD-PhD requirement; formal neurology training recommended.