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About the Role

Denali Therapeutics is seeking an Executive Medical Director to lead program strategy and clinical development of TransportVehicle (TV) platform therapeutics for neurodegenerative diseases and inherited metabolic disorders. This role involves driving clinical programs, portfolio-level decision-making, and ensuring scientific integrity and regulatory compliance.

Responsibilities

• Provides medical oversight of clinical trial design, ensuring scientific rigor, endpoint defensibility, and alignment with regulatory expectations.
• Establishes clinical development standards, frameworks, and best practices across programs.
• Provides expertise and contributes to advisory board planning and execution, steering committee meetings, and data safety management committees.
• Leads preparation and discussions for health authority interactions, NDA/BLA or MAA submissions, and labeling negotiations.
• Provides medical input on proposed indications, contraindications, warnings, dosing language, and patient population definitions.
• Provides clinical oversight of post-approval commitments, confirmatory studies, and life cycle management planning.
• Analyzes, interprets, and communicates data to inform key decisions, providing clear recommendations to guide clinical development strategy.
• Plays a leadership role in guiding cross-functional teams to consensus (Regulatory, Commercial, Legal, Clinical).
• Establishes and maintains relationships with key opinion leaders (KOLs), clinical investigators, and external stakeholders to advance clinical initiatives.
• Manages clinical trial timelines and resources, ensuring the delivery of high-quality results aligned with corporate objectives.
• Partners with senior functional leaders to align clinical strategy, resourcing, and program execution.
• Drives publication strategy, including manuscripts, abstracts, and posters from registrational trials; manages relationships with academic collaborators and publication committees.
• Represents the company in interactions with patient advocacy organizations; supports disease awareness and patient support program development.
• Ensures compliance with training and all GCP requirements.

Requirements

• M.D. or M.D./Ph.D. with formal training in neurology, neuroscience, genetics, immunology, and/or rare disease.
• Minimum 12 years of combined experience, with at least 7 years in the pharmaceutical or biotechnology industry in senior medical/clinical roles.
• Typically 3 or more years in a people management role, with demonstrated success in talent development, performance management, and team building.
• Deep expertise in clinical trial design, endpoint strategy, SAP development, regulatory interactions, and DSMB/IDMC processes.
• Proven experience leading or contributing significantly to a pivotal trial data readout, including topline analysis, NDA/BLA regulatory submission, and external data disclosure.
• Prior experience working closely with Commercial teams in a pre-launch or launch setting.
• Strong scientific communication skills; experienced presenting clinical data at major medical congresses and in peer-reviewed publications.
• Demonstrates a proactive, self-starting approach with the ability to influence and drive programs forward.
• Experience in a leadership role in clinical development programs in both a biotech and larger pharmaceutical company setting.
• Experience achieving FDA approval via accelerated pathways (Breakthrough Therapy Designation, Accelerated Approval, Fast Track) in a CNS or rare disease indication.
• Familiarity with rare neurological disease designations (Orphan Drug, PRIMe) and their commercial and regulatory implications.

Skills

• Neurology
• Neuroscience
• Genetics
• Immunology
• Rare disease
• Clinical trial design
• Endpoint strategy
• SAP development
• Regulatory interactions
• DSMB/IDMC processes
• Pivotal trial data readout
• NDA/BLA regulatory submission
• External data disclosure
• Commercial team collaboration
• Scientific communication
• Presenting clinical data
• Peer-reviewed publications
• Proactive approach
• Influencing
• Driving programs
• Leadership
• Talent development
• Performance management
• Team building
• Accelerated pathways
• CNS indications
• Rare disease indications
• Orphan Drug designation
• PRIMe designation

Experience Level

• Minimum 12 years of combined experience
• At least 7 years in the pharmaceutical or biotechnology industry in senior medical/clinical roles
• Typically 3 or more years in a people management role

Education Level

• M.D. or M.D./Ph.D.

Salary/Compensations

• $345,000.00 to $425,000.00

Benefits

• 401k
• Healthcare coverage
• ESPP

About the Company

• Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through its deep commitment to degeneration biology and principles of translational medicine.
• Denali has engineered the TransportVehicle (TV) platform enabling the delivery of enzymes, oligonucleotides and antibodies that cross the blood brain barrier and provide enhanced peripheral distribution.
• Biotherapeutics in the TV platform have the potential to unlock treatment for serious diseases that are not available through traditional approaches.
• Denali is committed to its core company value of unity by creating a diverse and inclusive environment.
• “Life at Denali” is a living reflection of our values: trust, unity, grit and growth. These are not just words we share—they shape how we show up, collaborate and push boundaries together. From the lab to the community, across functions and milestones, our culture thrives on shared purpose and relentless pursuit.

Equal Opportunity

• Denali is proud to be an equal opportunity employer and does 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.