Global Senior Manager Early Access Programs

Role Summary

Global Senior Manager Early Access Programs leads operational implementation and oversight of MAP programs and related operations within Specialty Care, ensuring compliance with global and local regulations. The role partners with Medical TA, procurement, quality, and cross-functional teams to drive end-to-end management of Early Access Programs and related initiatives, from eligibility and country selection to program reporting and governance.

• 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, maintaining portfolio overview and optimizing resource allocation
• Provide continuous improvement and process simplification for organizational efficiency and effectiveness and excellence in execution of MAP programs & PRIL
• Ensure Global & Local structured programs end to end oversight and visibility and support global medical teams in eligibility determination, country selection and blueprint validation; set up stakeholder meetings per program from start until implementation
• As the Senior Global Manager of MAP operations, partner with Medical TA to conduct periodic portfolio reviews & mitigation meetings, keeping global medical, local stakeholders and alliance partners updated on progress
• Oversee vendor selection & contract execution of structured programs at program and portfolio level to ensure operational excellence and end-to-end visibility and adherence to KPIs
• Establish program-level end-to-end patient treatment accountability and program reporting
• Provide periodic updates on R&D pipeline and MAP proactive planning and relevance
• Liaise with procurement and global quality to address non-supply-related topics with MAP program vendors
• Ensure close partnership with Medical Product Supply Lead & Sanofi Global Hub to address supply-related topics with vendors (supply quality, forecast, logistics, inventory, cold chain, shelf life, distribution, etc.) and provide insight to 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 operations team
• Maintain close Glocal 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; perform quality assurance to improve processes and minimize risk
• Oversee development, enhancement and maintenance of MAP iEnvision, dashboards and tools

• Required:
  
  10+ years in the biopharmaceutical industry expanding roles in Medical, Medical Operations or related field, with experience managing complex cross-functional programs and ability to bridge between different fields of expertise; proactive troubleshooting and risk management
• Required:
  
  Strong knowledge of the drug development process, regulatory and business requirements related to Early Access Programs
• Required:
  
  Demonstrated expertise in early access operations and end-to-end management of Early Access Programs
• Required:
  
  Prior work experience managing GXP activities

• Strong leadership and facilitation skills; excellent interpersonal communication in English
• Excellent stakeholder management skills
• Exceptional communication skills with ability to articulate technical concepts to diverse audiences; data analytics and content development skills
• Change management expertise with success in adopting new technologies
• Proficiency in Excel;
  PowerPoint, project management tools, Jira, Smartsheet, Power Bi, AI tools
• Ability to act with urgency
• Track record of implementing innovative solutions delivering measurable business impact

• Degree in scientific discipline (PhD, Pharm
  
  D, MD or related scientific master's degree)