Executive Medical Director
Denali Therapeutics
June 24, 2026
Remote friendly (South San Francisco, CA)
United States
Medical Affairs
Key Accountabilities / Core Job Responsibilities
- Provide medical oversight of clinical trial design (scientific rigor, endpoint defensibility, regulatory alignment).
- Establish clinical development standards, frameworks, and best practices.
- Support advisory board/steering committee planning and execution; contribute to DSMB/IDMC activities.
- Lead Type A/B/C health authority interactions; support NDA/BLA/MAA submissions and labeling negotiations.
- Provide medical input on indications, contraindications, warnings, dosing language, and patient population definitions.
- Oversee post-approval commitments, confirmatory studies, and life-cycle management planning.
- Analyze, interpret, and communicate data to guide clinical development strategy.
- Lead cross-functional alignment (Regulatory, Commercial, Legal, Clinical).
- Build relationships with KOLs, investigators, and external stakeholders.
- Manage clinical trial timelines and resources to deliver high-quality results.
- Partner with senior leaders to align clinical strategy, resourcing, and execution.
- Drive publication strategy (manuscripts/abstracts/posters) and manage academic publication collaborators.
- Represent the company with patient advocacy organizations; support disease awareness and patient support programs.
- Comply with training and all GCP requirements.
Required Qualifications / Skills
- M.D. or M.D./Ph.D. with training in neurology, neuroscience, genetics, immunology, and/or rare disease.
- 12+ years combined experience; at least 7 years in pharma/biotech senior medical/clinical roles.
- 3+ years people management experience.
- Expertise in clinical trial design, endpoint strategy, SAP development, regulatory interactions, and DSMB/IDMC processes.
- Experience with pivotal trial readouts and NDA/BLA submission/data disclosure.
- Experience working with Commercial teams (pre-launch/launch).
- Strong scientific communication (major congresses; peer-reviewed publications).
Preferred
- Clinical development leadership in both biotech and larger pharma.
- FDA accelerated approval experience (Breakthrough Therapy, Accelerated Approval, Fast Track) in CNS or rare disease.
- Knowledge of rare neurological disease designations (Orphan Drug, PRIMe).
Compensation/Benefits (as stated)
- Salary range: $345,000.00–$425,000.00
- 401k, healthcare coverage, ESPP, and other benefits.
Application Instructions
- Learn more: https://www.denalitherapeutics.com/careers
- Provide medical oversight of clinical trial design (scientific rigor, endpoint defensibility, regulatory alignment).
- Establish clinical development standards, frameworks, and best practices.
- Support advisory board/steering committee planning and execution; contribute to DSMB/IDMC activities.
- Lead Type A/B/C health authority interactions; support NDA/BLA/MAA submissions and labeling negotiations.
- Provide medical input on indications, contraindications, warnings, dosing language, and patient population definitions.
- Oversee post-approval commitments, confirmatory studies, and life-cycle management planning.
- Analyze, interpret, and communicate data to guide clinical development strategy.
- Lead cross-functional alignment (Regulatory, Commercial, Legal, Clinical).
- Build relationships with KOLs, investigators, and external stakeholders.
- Manage clinical trial timelines and resources to deliver high-quality results.
- Partner with senior leaders to align clinical strategy, resourcing, and execution.
- Drive publication strategy (manuscripts/abstracts/posters) and manage academic publication collaborators.
- Represent the company with patient advocacy organizations; support disease awareness and patient support programs.
- Comply with training and all GCP requirements.
Required Qualifications / Skills
- M.D. or M.D./Ph.D. with training in neurology, neuroscience, genetics, immunology, and/or rare disease.
- 12+ years combined experience; at least 7 years in pharma/biotech senior medical/clinical roles.
- 3+ years people management experience.
- Expertise in clinical trial design, endpoint strategy, SAP development, regulatory interactions, and DSMB/IDMC processes.
- Experience with pivotal trial readouts and NDA/BLA submission/data disclosure.
- Experience working with Commercial teams (pre-launch/launch).
- Strong scientific communication (major congresses; peer-reviewed publications).
Preferred
- Clinical development leadership in both biotech and larger pharma.
- FDA accelerated approval experience (Breakthrough Therapy, Accelerated Approval, Fast Track) in CNS or rare disease.
- Knowledge of rare neurological disease designations (Orphan Drug, PRIMe).
Compensation/Benefits (as stated)
- Salary range: $345,000.00–$425,000.00
- 401k, healthcare coverage, ESPP, and other benefits.
Application Instructions
- Learn more: https://www.denalitherapeutics.com/careers