Executive Medical Director
Denali Therapeutics
August 06, 2026
Remote friendly (South San Francisco, CA)
United States
Medical Affairs
Key Accountabilities / Core Job Responsibilities
- Provide medical oversight of clinical trial design, ensuring scientific rigor, endpoint defensibility, and alignment with regulatory expectations.
- Establish clinical development standards, frameworks, and best practices across programs.
- Contribute to advisory board planning/execution, steering committee meetings, and data safety management committees.
- Lead preparation and discussions for Type A/B/C health authority interactions, NDA/BLA or MAA submissions, and labeling negotiations.
- Provide medical input on indications, contraindications, warnings, dosing language, and patient population definitions.
- Provide clinical oversight of post-approval commitments, confirmatory studies, and life cycle management planning.
- Analyze, interpret, and communicate data to inform key decisions and guide clinical development strategy.
- Lead cross-functional consensus (Regulatory, Commercial, Legal, Clinical).
- Establish and maintain relationships with KOLs, clinical investigators, and external stakeholders.
- Manage clinical trial timelines and resources to deliver high-quality results aligned with corporate objectives.
- Partner with senior functional leaders to align clinical strategy, resourcing, and program execution.
- Drive publication strategy (manuscripts, abstracts, posters) and manage academic collaborator/publication committee relationships.
- Represent the company with patient advocacy organizations; support disease awareness and patient support program development.
- Ensure compliance with training and all GCP requirements.
Required Qualifications / Skills
- M.D. or M.D./Ph.D. with formal training in neurology, neuroscience, genetics, immunology, and/or rare disease.
- 12+ years combined experience; 7+ years in pharma/biotech in senior medical/clinical roles.
- 3+ years people management experience with demonstrated talent/performance/team leadership.
- Deep expertise in clinical trial design, endpoint strategy, SAP development, regulatory interactions, and DSMB/IDMC processes.
- Experience leading/contributing to pivotal trial readouts (topline analysis, NDA/BLA submission, external data disclosure).
- Experience working with Commercial teams in pre-launch/launch settings.
- Strong scientific communication; present clinical data at major congresses and in peer-reviewed publications.
- Proactive self-starter who can influence and drive programs forward.
Preferred Qualifications / Skills
- Leadership experience across biotech and larger pharma clinical development programs.
- FDA accelerated pathway experience (Breakthrough Therapy Designation, Accelerated Approval, Fast Track) in CNS or rare disease.
- Familiarity with rare neurological disease designations (Orphan Drug, PRIMe) and their commercial/regulatory implications.
Benefits/Compensation
- Salary range: $345,000–$425,000; includes 401k, healthcare coverage, ESPP, and other benefits.
Application Instructions
- Learn more at https://www.denalitherapeutics.com/careers.
- Provide medical oversight of clinical trial design, ensuring scientific rigor, endpoint defensibility, and alignment with regulatory expectations.
- Establish clinical development standards, frameworks, and best practices across programs.
- Contribute to advisory board planning/execution, steering committee meetings, and data safety management committees.
- Lead preparation and discussions for Type A/B/C health authority interactions, NDA/BLA or MAA submissions, and labeling negotiations.
- Provide medical input on indications, contraindications, warnings, dosing language, and patient population definitions.
- Provide clinical oversight of post-approval commitments, confirmatory studies, and life cycle management planning.
- Analyze, interpret, and communicate data to inform key decisions and guide clinical development strategy.
- Lead cross-functional consensus (Regulatory, Commercial, Legal, Clinical).
- Establish and maintain relationships with KOLs, clinical investigators, and external stakeholders.
- Manage clinical trial timelines and resources to deliver high-quality results aligned with corporate objectives.
- Partner with senior functional leaders to align clinical strategy, resourcing, and program execution.
- Drive publication strategy (manuscripts, abstracts, posters) and manage academic collaborator/publication committee relationships.
- Represent the company with patient advocacy organizations; support disease awareness and patient support program development.
- Ensure compliance with training and all GCP requirements.
Required Qualifications / Skills
- M.D. or M.D./Ph.D. with formal training in neurology, neuroscience, genetics, immunology, and/or rare disease.
- 12+ years combined experience; 7+ years in pharma/biotech in senior medical/clinical roles.
- 3+ years people management experience with demonstrated talent/performance/team leadership.
- Deep expertise in clinical trial design, endpoint strategy, SAP development, regulatory interactions, and DSMB/IDMC processes.
- Experience leading/contributing to pivotal trial readouts (topline analysis, NDA/BLA submission, external data disclosure).
- Experience working with Commercial teams in pre-launch/launch settings.
- Strong scientific communication; present clinical data at major congresses and in peer-reviewed publications.
- Proactive self-starter who can influence and drive programs forward.
Preferred Qualifications / Skills
- Leadership experience across biotech and larger pharma clinical development programs.
- FDA accelerated pathway experience (Breakthrough Therapy Designation, Accelerated Approval, Fast Track) in CNS or rare disease.
- Familiarity with rare neurological disease designations (Orphan Drug, PRIMe) and their commercial/regulatory implications.
Benefits/Compensation
- Salary range: $345,000–$425,000; includes 401k, healthcare coverage, ESPP, and other benefits.
Application Instructions
- Learn more at https://www.denalitherapeutics.com/careers.