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.
Key Accountabilities / Core Job 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
Qualifications / Skills:Required
- 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
Preferred
- 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
Salary Range: $345,000.00 to $425,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.
