Director, Patient Support Strategy & Operations will play a critical role in building and scaling patient support and access capabilities for upcoming product launches and ongoing commercialization efforts. This individual will lead the design and execution of patient support programs, including the establishment and optimization of the Patient Access Hub, affordability programs, and provider support pathways. This role requires a strong blend of strategic thinking and operational execution to ensure seamless patient onboarding, efficient therapy initiation, and a high-quality patient and provider experience. The Director will work cross-functionally to align access strategies with commercial goals while ensuring compliance with all regulatory and legal requirements. Key Accountabilities / Core Responsibilities: Patient Support Strategy & Program Development Lead the development and execution of strategies to support product launches and lifecycle management. Design and operationalize Patient Access Hub services, including benefits investigation, prior authorization (PA) support, appeals, and case management. Establish and refine Patient Assistance Program (PAP) eligibility criteria and access frameworks. Develop and implement patient affordability programs, including copay assistance and financial support resources. Define provider support pathways to reduce access barriers and streamline therapy initiation. Operations & Vendor Management Oversee day-to-day Patient Access Hub operations and vendor performance, ensuring high service quality and compliance. Manage relationships with patient support program vendors and specialty pharmacy partners to support efficient patient onboarding. Establish standards for case triage, turnaround times, and quality metrics. Provide oversight for complex access cases, including free drug programs, in partnership with Medical, Legal, and Compliance as appropriate. Performance Management & Continuous Improvement Establish and monitor key performance indicators, including: Time-to-therapy Patient onboarding timelines HUB performance and compliance metrics Effectiveness of patient support programs Drive continuous improvement initiatives to enhance access, affordability, and operational efficiency. Leverage data and analytics to inform decisions and optimize program performance. Governance & Compliance Ensure all patient support programs operate in full compliance with regulatory and legal requirements. Contribute to development of SOPs, policies, and governance frameworks for patient support and access. Partner with Legal and Compliance to manage risk and ensure appropriate program design. Cross-Functional Collaboration Partner closely with Market Access, Marketing, Distribution, Payer Strategy, Sales, Medical Affairs, Legal, Compliance, and Commercial teams. Collaborate with the patient services team and Sales leadership to identify provider education needs related to access and reimbursement. Represent patient support and access in cross-functional forums and contribute to broader commercial strategy discussions. Qualifications/Skills: Education & Experience Typically requires a BS/BA and 10+ years of experience in pharmaceutical/biotech patient support, access, reimbursement, hub operations, or specialty pharmacy. Demonstrated experience launching and managing patient support programs, particularly hybrid field/HUB models. Advanced degree preferred Experience designing and managing patient affordability programs (copay, PAP). Proven track record managing external vendors and service providers. Experience in specialty or rare disease therapeutic areas preferred. Knowledge, Skills, and Abilities Strong expertise in patient support strategy, reimbursement, and HUB operations, with demonstrated ability to design and operationalize scalable, patient-centric programs Working knowledge of compliance regulations related to copay and patient assistance programs. Strong understanding of U.S. payer systems, including Commercial, Medicaid, and Medicare (Part B and Part D), and medical vs. pharmacy benefit design Proven cross-functional collaboration and stakeholder management skills. Analytical mindset with the ability to leverage data and insights to inform decision-making and continuously optimize program performance Excellent communication skills with ability to influence across functions Ability to manage multiple priorities in a fast-paced environment, with strong attention to detail and execution Should be willing & able to travel 25-30% Salary Range: $204,000.00 to $265,000.00 . 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.