Associate Director, Medical Excellence & Operations

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. Denali is seeking a highly skilled and experienced Associate Director, Medical Excellence & Operations who will be responsible for leading key operational functions within Medical Affairs, including Medical Excellence, Expanded Access Program (EAP) operations, and Grants operations. This role will develop and implement best practices to enhance medical strategy operations efficiency, governance, and execution. Key Accountabilities/Core Job Responsibilities: Medical Excellence Operations Contribute to the development and implementation of medical strategies, plans, and initiatives to support product lifecycle management and address unmet medical needs. Contribute to the development and execution of medical plans, ensuring alignment with overall company objectives and regulatory requirements. Develop and implement processes, tools, and training to enhance operational effectiveness within Medical Affairs. Establish governance frameworks and ensure alignment with internal policies and external regulations. Partner with cross-functional teams (Compliance, Legal, Commercial, Advocacy, R&D) to drive medical strategy execution and optimize workflows. Lead metrics tracking, reporting, and continuous improvement initiatives across Medical Affairs. Support digital innovation and system integration for Medical Affairs functions. Expanded Access Program (EAP) Operations Oversee the operational management of Expanded Access Programs, ensuring compliance with regulatory and ethical guidelines. Develop and implement processes to evaluate and respond to EAP requests efficiently. Collaborate with Clinical, Regulatory, and Commercial teams to ensure seamless program execution and alignment with corporate priorities. Monitor program performance and report key insights to leadership. Grants & Funding Operations Lead the management and oversight of independent medical education grants, investigator-initiated studies, and charitable donations. Ensure grant processes adhere to internal policies and external compliance requirements. Collaborate with Medical Affairs leadership to assess funding priorities and make recommendations. Track and report on grant outcomes to demonstrate impact and compliance. Qualifications & Experience BA or BS in Health Sciences or related discipline, PhD/MD/MBA is a plus. At or near 7 years of experience in Medical Affairs operations, with expertise in Medical Excellence, Expanded Access, and Grants operations. Strong aptitude and interest in science, drug development process and commercialization pathways, particularly in the biopharma space Strong knowledge of pharmaceutical industry regulations, including FDA, EMA, ICH, and compliance frameworks. Proven ability to develop and implement operational best practices in a fast-paced environment. Excellent project management skills and ability to drive cross-functional collaboration. Strong analytical, strategic thinking, and problem-solving skills. Ability to communicate effectively with internal and external stakeholders. Ability to prioritize and flex in a fast-paced growth environment. Curiosity, strong work ethic and a sense of humor. Salary Range: $188,000.00 to $237,333.00 . 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: , San Bruno , Associate Director, Medical Excellence & Operations, Science, Research & Development , South San Francisco, California