Vice President, U.S. Market Access

Key Accountabilities/Core Job Responsibilities:

US Market Access Leadership

• Lead U.S. market access strategy for Denali’s portfolio, including launch and post-launch optimization for AVLAYAH and future pipeline assets.

• Develop integrated strategies across payer engagement, coverage, reimbursement, and patient support tailored to rare disease and specialty infusion/orphan markets.

• Shape access strategy to support accelerated approval pathways and subsequent label expansion (e.g., sBLA, lifecycle management).

• Partner with Commercial leadership to define go-to-market strategy, including patient segmentation, site-of-care strategy, and provider access pathways.

• Provides executive leadership to the US Market Access Leadership Team, with oversight spanning Payer Field Team, Patient Access and Experience, Pricing, Contracting, Channel Operations and Strategy, and Government Price Reporting.

Payer, Pricing, and Policy Strategy

• Lead engagement strategy across commercial and government payers, addressing complex coverage dynamics in rare and ultra-rare diseases.

• Develop and execute pricing and contracting strategies, including gross-to-net optimization and value-based considerations where appropriate.

• Anticipate and navigate evolving payer policies related to gene/enzyme therapies, biomarkers, and surrogate endpoints.

• Provide strategic guidance to executive leadership on reimbursement risks, policy changes, and access barriers.

Evidence Generation & Value Demonstration

• Define payer value proposition grounded in clinical, biomarker, and real-world evidence (e.g., HS/CSF HS endpoints).

• Lead development of value dossiers, HEOR models, and access-focused evidence strategies to support coverage and AA-to-full approval conversion.

• Partner with Medical Affairs and Clinical teams to ensure access-relevant endpoints and RWE strategies are incorporated into studies (e.g., COMPASS, E8).

• Support publication and communication strategies to reinforce value with payers and key stakeholders.

Patient Access & Support Programs

• Design and oversee patient support infrastructure, including HUB services, prior authorization support, and affordability programs.

• Ensure seamless patient onboarding and therapy initiation, particularly for complex infusion-based therapies.

• Oversee compassionate use and early access programs, ensuring alignment with ethical, regulatory, and patient-centric principles.

• Continuously optimize patient experience and reduce barriers to treatment.

Trade, Distribution & Site-of-Care Strategy

• Define and manage specialty pharmacy and distribution strategy, including site-of-care optimization (e.g., CoEs, infusion centers).

• Partner with Supply Chain and Commercial teams to ensure reliable and efficient product access.

• Align channel strategy with patient journey and payer requirements.

Operations, Analytics & Performance

• Establish and track key access metrics, including time-to-therapy, patient onboarding, and payer approval rates.

• Drive data-driven decision-making to optimize access performance and patient outcomes.

• Lead continuous improvement initiatives to enhance operational efficiency and scalability.

Pipeline & Global Alignment

• Partner with Global Insights and Operations to assess access strategy for pipeline and external assets.

• Ensure scalability of access infrastructure to support global expansion and future indications.

• Align U.S. access strategy with global evidence and regulatory strategies where appropriate.

Leadership & Cross-Functional Influence

• Lead a high-performing, agile market access team.

• Serve as a key member of the CMPA Leadership Team and strategic advisor to executive leadership.

• Collaborate closely with CMPA, Medical Affairs, Clinical Development, Regulatory, Legal, Compliance, Finance, and Commercial teams.

• Drive alignment across functions to deliver a cohesive, patient-centered access strategy.

• 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/Skills:

• Typically requires a Bachelor’s degree and 20+ years of experience in biotech/pharma, including senior leadership roles in market access and 15+ years of people leadership experience; an advanced degree (MBA, MPH, PharmD, PhD) is preferred.

• Deep expertise in U.S. payer systems, reimbursement, and specialty/orphan drug access dynamics.

• Strong understanding of biomarker-driven development, surrogate endpoints, and their implications for payer acceptance.

• Experience with HEOR, RWE, and value-based access strategies in complex disease areas.

• Proven ability to shape payer perception and navigate ambiguity in emerging therapeutic areas.

• Strong strategic thinking combined with hands-on execution.

• Excellent leadership, communication, and stakeholder management skills.

• Ability to operate effectively in a fast-paced, evolving environment.

• High integrity and commitment to compliance and patient-centric decision-making.

• Proven experience launching therapies in rare disease, neurology, or specialty markets.

• Strong experience with accelerated approval pathways, lifecycle management, and evidence-based access strategies.

• Experience in pre-commercial or emerging biotech environments preferred.