Global Senior Manager Early Access Programs

Global Senior Manager Early Access Programs

Job Title: Global Senior Manager Early Access Programs

Location: Cambridge, MA or Morristown, NJ

Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological conditions. In Specialty Care, you’ll help deliver breakthrough treatments that bring hope to patients with some of the highest unmet needs. The Global Senior Manager Early Access Programs sits within Specialty Care Managed Access Programs (MAP) and Cross‑GBU On‑Demand Import License (ODIL) Operations MAP, designed to help patients with serious or life‑threatening conditions access investigational products when they don’t respond to or tolerate approved therapies and when they are not eligible to participate in a clinical trial.

• Lead operational implementation and setup of individual and structured MAP Programs & cross GBU PRIL operations in compliance with company policies, procedures and applicable global and local regulations, ensuring compliance, maintaining portfolio oversight and optimizing resource allocation.
• Provide continuous improvement and process simplification for organizational efficiency and effectiveness, driving excellence in execution of MAP programs & PRIL.
• Ensure global & local structured programs have end‑to‑end oversight and visibility; support global medical teams in eligibility determination, country selection, and blueprint validation; set up stakeholder meetings per program from start to implementation.
• Act as Senior Global Manager of MAP operations and business partner to Medical TA; conduct periodic TA portfolio review & mitigation meetings, keeping global medical, local stakeholders and alliance partners updated on program progress.
• Oversee vendor selection & contract execution for structured programs at program and portfolio level, ensuring operational excellence, end‑to‑end visibility and adherence to agreed operational KPIs.
• Set up a program‑level end‑to‑end patient treatment accountability and program reporting.
• Provide periodic updates on R&D pipeline and proactive MAP planning and relevance.
• Liaise with procurement and global quality to address non‑supply related topics with MAP program vendor.
• Ensure close partnership with Medical Product Supply Lead & Sanofi Global Hub (SGH) to address supply topics with vendors (e.g., supply quality, forecast, logistics, inventory, cold chain, shelf life, distribution) and provide insight into supply aspects of global & local structured MAP.
• Represent MAP operations in quarterly vendor business reviews in collaboration with Product Supply Lead.
• Oversee program allocation and resource optimization across the global operation team.
• Maintain close co‑local collaboration with local regional medical and operational teams.
• Lead digital transformation and AI integration of global MAP operations.
• Represent MAP Global Operation at Managed Access Industry Forum (MAIF) for Early Access Programs.
• Ensure MAP & ODIL operations audit readiness and CAPA implementation in collaboration with MAP Governance Lead and MAP Global Governance Sr. Manager, performing quality assurance to improve processes, minimize risk, and perform quality control.
• Oversee development, enhancement, and maintenance of MAP iEnvision dashboards and tools.

• 10+ years in the biopharmaceutical industry, expanding roles in Medical, Medical Operations or related fields; experience and understanding of the current pharmaceutical environment; successful management of complex, business‑critical cross‑functional programs; ability to bridge expertise fields; proactive troubleshooting of program risks and challenges (including scenario and contingency planning).
• Strong knowledge of drug development process, regulatory and business requirements related to Early Access Programs.
• Demonstrated expertise in early access operations and end‑to‑end management of Early Access Programs.
• Prior work experience managing GXP activities.

• Strategic thinking: ability to disrupt status quo with innovation while remaining pragmatic and focused on priorities.
• Result orientation: driven to develop…