Global Senior Manager Early Access Programs

Overview

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.

Global Senior Manager Early Access Programs sits within Specialty Care Managed Access Programs (MAP) and Cross-GBU On Demand Import License (ODIL) Operations. MAP is designed to help patients with serious or life-threatening conditions to have access to investigational products when they don’t respond or tolerate approved therapies and when they are not eligible to participate in a clinical trial.

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

• 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, always ensuring compliance and maintaining the portfolio overview and oversight and optimize 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 stakeholders meeting per program from start until implementation
• As the Senior Global Manager of MAP operation and a business partner to Medical TA responsible for conducting periodic TA portfolio review & mitigation meetings keeping global medical, local stakeholders and alliance partner updated and informed of programs progress
• Oversee vendor's selection & contract execution of structured program at program and portfolio level to ensure operational excellence and end to end visibility and respect to agreed operational KPIs
• Set up a program level end-to-end patient treatment accountability and program reporting
• Provide periodic update 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 vendor
• Ensure close partnership with Medical Product Supply Lead & Sanofi Global Hub (SGH) to address supply related topics with vendors (i.e, supply quality, forecast, logistics, inventory, cold chain, shelf life, distribution, etc.) and provide insight to supply aspect 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 operation team
• Maintain close Glocal collaboration with local regional medical and operational teams
• Lead digital transformation and AI integration of global MAP operation
• 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. Manger, perform quality assurance to improve process and minimize risk, perform quality control to mitigate risk
• 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 field, including experience, and understanding of the current pharmaceutical environment, with experience of successful management of complex business critical cross functional programs, ability to successfully bridge between different fields of expertise, proactive troubleshooting managing program risks and challenges (including scenario and…