Global Senior Manager Early Access Programs

Role Summary

Global Senior Manager Early Access Programs, based in Cambridge, MA or Morristown, NJ. This role sits within Specialty Care Managed Access Programs (MAP) and Cross-GBU On Demand Import License (ODIL) Operations, overseeing end-to-end MAP and PRIL operations to provide access to investigational products for patients with serious or life-threatening conditions who are not eligible for trials or do not respond to approved therapies.

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 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; 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 for periodic portfolio reviews and mitigation meetings, keeping global medical, local stakeholders and alliance partners updated
• Oversee vendor selection & contract execution of structured programs at program and portfolio level to ensure operational excellence and end-to-end visibility
• 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; provide insight to global & local MAP supply aspects
• 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 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; perform quality assurance to improve process and minimize risk
• Oversee development, enhancement and maintenance of MAP iEnvision, dashboards and tools

Qualifications

• 10+ years in the biopharmaceutical industry with experience in Medical, Medical Operations or related fields; proven ability to manage complex cross-functional programs, troubleshoot, and manage program risks
• 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 interpersonal communication in English; well organized and results-driven with ability to manage multiple projects
• Excellent stakeholder management and 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 (Jira, Smartsheet, PowerBi, AI tools)
• Ability to act with urgency; track record of delivering innovative solutions with measurable impact

Education

• Degree in scientific discipline (PhD, PharmD, MD or related scientific masters)