Developmental Market Access & Policy Strategy Lead

Job Description

Summary The Developmental Market Access & Policy Strategy Lead plays a critical upstream role in ensuring that pipeline and early-stage products are designed with successful U.S. market access, reimbursement, and policy outcomes in mind. Rather than reacting at launch, this role proactively shapes development strategy so that products enter the market with a clear, evidence-backed pathway to coverage and adoption. This position operates at the intersection of R&D, policy, and commercialization, translating complex payer, regulatory, and policy dynamics into actionable development guidance. The individual ensures that access considerations are embedded early, reducing downstream barriers, accelerating time to reimbursement, and supporting long-term product viability.

Job Description

• Market Access Strategy for Developmental Assets
• Lead the creation of comprehensive U.S. market access strategies for pipeline products, starting in early development phases (pre-clinical through pivotal trials).
• Define target payer segments (e.g., Medicare, Medicaid, commercial plans, IDNs) and map expected coverage pathways.
• Anticipate payer decision drivers, including clinical differentiation, cost-effectiveness, and budget impact.
• Evaluate potential access barriers, such as prior authorization, step therapy, site-of-care restrictions, and network limitations.
• Establish clear access-related milestones and criteria to ensure products are “launch-ready” from a reimbursement and policy perspective.
• Partner with commercial and brand teams to align early access strategies with future go-to-market planning.
• Policy Strategy & Integration
• Continuously monitor and interpret the evolving U.S. healthcare policy landscape, including CMS regulations, MAC determinations, and federal/state policy trends.
• Analyze historical precedents to predict how similar technologies have been treated from a coverage and payment standpoint.
• Identify policy-driven risks and opportunities, including potential changes in reimbursement models, value-based care initiatives, and site-of-service policies.
• Develop forward-looking policy scenarios and contingency strategies to guide development and commercialization decisions.
• Collaborate closely with Government Affairs and Policy teams to align internal strategies with external advocacy efforts.
• Evidence Strategy & Development Alignment
• Translate payer and policy requirements into specific evidence needs, ensuring clinical development programs generate data relevant for coverage decisions—not just regulatory approval.
• Advise on clinical trial design elements, such as endpoints, comparators, patient populations, and real-world evidence integration.
• Partner with HEOR (Health Economics & Outcomes Research) to define economic and outcomes evidence (e.g., cost-effectiveness, budget impact models).
• Ensure alignment between clinical, economic, and real-world evidence strategies to support value demonstration across stakeholders.
• Identify and address evidence gaps early, reducing the risk of delayed or restricted access post-launch.
• Coverage, Coding & Reimbursement Strategy
• Assess coding pathways (CPT, HCPCS, DRG/APC) and determine feasibility of existing vs. new codes.
• Evaluate reimbursement methodologies across care settings (hospital inpatient/outpatient, physician office, ambulatory, etc.).
• Identify potential challenges related to payment adequacy, bundling, or site-of-care shifts.
• Incorporate reimbursement considerations into overall access strategy, including pricing and contracting implications.
• Partner with reimbursement and coding experts to define optimal payment positioning and strategies.
• Governance & Portfolio Support
• Represent Market Access and Policy perspectives in cross-functional governance forums, including pipeline reviews and investment decisions.
• Provide strategic input on portfolio prioritization, highlighting access feasibility and risk-adjusted value.
• Proactively identify and escalate key access and policy risks, offering data-driven recommendations and mitigation plans.
• Support leadership with clear, concise insights that inform critical development and commercialization decisions.
• Ensure consistent integration of access strategy across the product lifecycle—from development through launch planning.

Day-to-Day Activities (What This Role Actually Does)

• Leading cross-functional meetings with R&D, HEOR, and commercial teams to align evidence and access strategy
• Developing payer archetypes and scenario models for coverage outcomes
• Reviewing clinical protocols to ensure p