Executive Medical Director

Denali Therapeutics•South San Francisco, CA

1d•$345,000 - $425,000

About The Position

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. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegeneration and other serious medical conditions. 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. The Executive Medical Director will serve as a senior medical leader driving program strategy and clinical development of TV-mediated therapeutics aimed at treating neurodegenerative diseases and inherited metabolic disorders. This individual will play a key leadership role in the design and execution of clinical programs, including portfolio-level decision-making and strategic direction, ensuring scientific integrity, regulatory compliance, and alignment with program objectives. The successful candidate will bring proven expertise and success in advancing therapeutic development programs, the ability to manage complex programs in a fast-paced environment, and a passion for improving the lives of individuals and families living with neurodegenerative and other serious diseases.

Requirements

M.D. or M.D./Ph.D. with formal training in the areas of 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

Nice To Haves

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

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.
Provide expertise and contribute as needed to advisory board planning and execution, steering committee meetings, and data safety management committees
Leads preparation and discussions for Type A/B/C health authority interactions, NDA/BLA or MAA submissions, and labeling negotiations
Leads 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
Analyze, interpret, and communicate data to inform key decisions, providing clear recommendations to guide clinical development strategy.
Play a leadership role in guiding cross functional teams to consensus (Regulatory, Commercial, Legal, Clinical)
Establish and maintain 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; manage relationships with academic collaborators and publication committees
Represent the company in interactions with patient advocacy organizations; support disease awareness and patient support program development
Compliance with training and all GCP requirements