Global Senior Manager Early Access Programs

Role Summary

Global Senior Manager Early Access Programs leads the operational implementation and oversight of MAP Programs and cross-GBU PRIL operations within Specialty Care, ensuring compliance with policies and regulations while optimizing resources. The role partners with medical, procurement, quality, and vendor teams to manage end-to-end programs, drive continuous improvement, and lead digital transformation and AI integration for MAP operations.

Responsibilities

• 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 oversight 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 and a 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 of structured programs at program and portfolio level to ensure operational excellence and end-to-end visibility and adherence to KPIs.
• Set up a 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 (SGH) to address supply-related topics with vendors (e.g., supply quality, forecast, logistics, inventory, cold chain, shelf life, distribution) and provide insight to supply aspects of global & local structured MAP.
• Represent MAP operations in the quarterly vendor business review in collaboration with Product Supply Lead.
• Oversee program allocation and resource optimization across 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 Operations at MAIF for Early Access Programs.
• Ensure MAP & ODIL operations audit readiness and CAPA implementation, collaborate with MAP Governance Lead and MAP Global Governance Sr. Manager, perform quality assurance to improve process and minimize risk, and perform quality control to mitigate risk.
• Oversee development, enhancement and maintenance of MAP iEnvision, dashboards and tools.

Qualifications

• 10+ years in the biopharmaceutical industry in Medical, Medical Operations or related field, with experience managing complex cross-functional programs and proactive risk management.
• Strong knowledge of the 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.

Skills

• Strong leadership and facilitation skills; excellent written and verbal English communication; well-organized with strong time management and the ability to manage multiple projects.
• Excellent stakeholder management skills; ability to articulate technical concepts to diverse audiences; strong data analytics and content development skills.
• Change management expertise with success in adopting new technologies.
• Proficiency in Excel, PowerPoint, project management tools (e.g., Jira, Smartsheet, Power BI, AI tools).
• Ability to act with urgency and deliver measurable business impact through innovative solutions.

Education

• Degree in scientific discipline (PhD, PharmD, MD or related scientific master’s degree).