Director, Patient Support Strategy & Operations (Remote Eligible)
Denali Therapeutics
Summary
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.
Job description
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.
Requirements
- 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
- Experience designing and managing patient affordability programs (copay, PAP)
- Proven track record managing external vendors and service providers
- Strong expertise in patient support strategy, reimbursement, and HUB operations
- 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
- Excellent communication skills with ability to influence across functions
- Ability to manage multiple priorities in a fast-paced environment
- Willing and able to travel
Benefits
- 401(k)
- Healthcare coverage
- ESPP
Company overview
Denali Therapeutics is a pioneering biotechnology company focused on developing innovative therapeutics for neurodegenerative and lysosomal storage diseases. Founded in 2015 and headquartered in South San Francisco, California, the company has developed a proprietary TransportVehicle™ (TV) platform designed to enable biotherapeutics to cross the blood-brain barrier, addressing one of the most significant challenges in treating central nervous system disorders. Denali's pipeline includes promising candidates for conditions such as Hunter syndrome (MPS II), Parkinson's disease, frontotemporal dementia, Sanfilippo syndrome (MPS IIIA), and MPS I, with several programs in advanced clinical development stages. The company collaborates with major pharmaceutical partners including Biogen and Sanofi, leveraging its platform technology to create a new class of barrier-crossing therapeutics. With approximately 500-1,000 employees and operations spanning multiple locations including Salt Lake City, Denali Therapeutics represents a leading force in neuroscience drug development, combining deep scientific expertise with a patient-centric approach to transform treatment paradigms for serious neurological conditions.