Global Value, Access and Commercialization Director – Regenerative Medicines

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the strategy and planning for OUS Market Access as well as the overall execution of commercialization.

• Spearhead the development and implementation of OUS market access, pricing, and reimbursement strategies in key OUS markets, in line with globally defined strategies.

• Convert global strategic goals into a practical OUS launch plan, including market access workstreams, milestones, and deliverables that align with global schedules.

• Take ownership of and manage daily execution of OUS market access priorities across various assets, ensuring alignment with central strategies, timelines, and long-term plans.

• Facilitate OUS launch readiness efforts that focus on access pathways, reimbursement planning, and pricing execution.

• Identify specific access risks, reimbursement hurdles, policy limitations, and operational dependencies that could affect OUS launch preparedness or uptake.

• Contribute to long-term international access planning, including launch sequencing assumptions, affordability considerations, and stakeholder engagement priorities.

• Provide organized insights from ex-US markets to guide global access strategy, evidence planning, and development of value narratives.

• Lead Health Technology Assessment (HTA) planning and execution across priority markets, including EU Joint Clinical Assessment (JCA) and relevant country-specific reimbursement pathways.

• Formulate country-specific pricing and reimbursement recommendations that adhere to centrally defined pricing guidelines.

• Assist in pricing and reimbursement negotiations in collaboration with regional stakeholders, affiliates, and external partners as necessary.

• Keep track of international pricing, reimbursement, and policy changes—including reference pricing and related cross-market risks—and suggest mitigation strategies.

• Represent ex-US access viewpoints in cross-functional planning and governance discussions, raising significant tradeoffs and recommendations as needed.

• Responsible for achieving OUS access outcomes, such as HTA success, reimbursement readiness, pricing alignment, and timely market access.

⛳️ Requirements

• A Bachelor's degree is required; an advanced degree is preferred (e.g., MBA, MPH, PharmD, PhD, MS, or equivalent).

• 10+ years of advancing business experience in the healthcare, pharmaceutical, or biotechnology industry, encompassing global market access, pricing & reimbursement, value strategy, HEOR interface, or global commercial strategy; experience in cell, gene, and regenerative medicines is a plus.

• Familiarity with EU markets and country-level HTAs, pricing, and reimbursement; experience with JCA is preferred.

• Strong grasp of payer, reimbursement, HTA, and access dynamics within OUS environments.

• Capability to consolidate clinical, economic, operational, and policy information into clear strategic recommendations.

• Exceptional communication, executive presence, and stakeholder management abilities.

• Experience in rare diseases, specialty therapeutics, biologics, cell therapy, gene therapy, tissue-based therapies, or other advanced modalities is highly preferred.

• Proven experience collaborating with regional teams, affiliates, distributors, or external commercialization partners.

• Must be willing to travel 30% of the time; some overnight travel is required.

🏝️ Benefits

• Merit-based salary increases.

• Participation in a short incentive plan.

• Eligibility for our 401(k) plan.

• Medical, dental, vision, life, and disability insurance coverage.

• Flexible paid time off.

• 11 paid holidays plus additional time off during the last week of December for a shut-down period.

• 80 hours of paid sick leave upon hire and every year thereafter.