Executive Director, Medical Affairs

Location: South San Francisco
Posted on: June 23, 2025

Job Description:

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. The Executive Director, Medical Affairs leads the strategic development and execution of medical affairs activities. This role will be responsible for shaping medical strategy, engaging with key stakeholders, and driving the evidence generation and communication plan to support our ETV portfolio across all key markets with a focus on the US in the short-term. The ideal candidate is a visionary leader with deep expertise in medical affairs, regulatory engagement, and commercial alignment. They will work closely with cross-functional teams, including R&D, Commercial, Market Access, Regulatory, and Clinical Development, to ensure scientific integrity and medical excellence across all initiatives. Key Accountabilities and Core responsibilities: Strategic Leadership & Execution Develop and execute comprehensive medical affairs strategies aligned with corporate and commercial objectives. Serve as the primary medical affairs leader overseeing scientific communications, medical education, KOL engagement, real-world evidence (RWE) generation, and medical insights. Partner with R&D and Clinical Development teams to provide medical expertise on pipeline assets and shape evidence generation plans. Collaborate with country leaders to ensure regional and country-specific medical needs are met while maintaining consistency in medical strategy. Key Stakeholder Engagement Build and maintain strong relationships with Key Opinion Leaders (KOLs), healthcare professionals (HCPs), payers, and regulatory bodies to drive scientific exchange and advocacy. Represent the company at scientific congresses, advisory boards, and industry forums to enhance the company’s reputation as a leader in the therapeutic space. Provide scientific and medical leadership for investigator-initiated studies (IIS), post-marketing studies, and collaborative research initiatives. Medical Strategy & Communications Oversee the development and execution of medical education programs, advisory boards, and scientific symposia. Lead publication planning and execution, ensuring high-quality scientific dissemination across key medical journals and conferences. Ensure alignment between global, regional, and local medical teams to optimize messaging and engagement strategies. Guide the development of medical and commercial materials, ensuring scientific accuracy and compliance with regulatory requirements. Cross-functional Collaboration & Compliance Act as a bridge between Medical Affairs, Commercial, Market Access, and R&D teams, ensuring alignment on product positioning and medical differentiation. Partner with regulatory and legal teams to ensure all medical activities comply with FDA, EMA, and other global regulatory requirements. Provide leadership on HEOR (Health Economics and Outcomes Research) initiatives to support value demonstration and payer engagement. Lead and mentor a high-performing global medical affairs team, fostering a culture of scientific excellence and innovation. If applicable, accountable to lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement. Qualifications & Experience: MD, PharmD, or PhD with extensive experience in Medical Affairs, Clinical Development, or Regulatory Affairs. At or near 10 years of experience in the pharmaceutical, biotechnology, or life sciences industry, with a strong background in global or US Medical Affairs Demonstrated people leadership, mentoring and coaching experience is preferred. Proven track record of leading medical strategies and teams in a complex, matrixed environment. Strong understanding of clinical development, regulatory landscapes, and payer expectations in the US and/or major international markets. Experience in launch planning, scientific engagement, and evidence generation in a highly competitive therapeutic area. Deep expertise in medical communications, scientific publications, and external stakeholder engagement. Excellent leadership skills with the ability to influence cross-functional teams and drive execution. Direct contributions to high-impact publications, regulatory filings, and/or product launches Experience with the design and conduct of clinical trials and clinical operations Excellent communication skills, including ability to create new materials to be used for both internal and external audiences Demonstrated customer focus and orientation Evident ability to lead, create, innovate, and flex within a changing environment Experience in rare disease and/or neurology is preferred but not required. Salary Range: $271,000.00 to $380,000.00 . 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. 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.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. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do 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.

Keywords: , Santa Rosa , Executive Director, Medical Affairs, Science, Research & Development , South San Francisco, California