Sanofi
Job Title:
Global Senior Manager Early Access Programs Location:
Cambridge, MA or Morristown, NJ About the Job
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 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. About Sanofi
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. Main 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, ensuring compliance and maintaining the portfolio overview and oversight while 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 TA portfolio reviews & mitigation meetings, keeping global medical, local stakeholders and alliance partners updated and informed of 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 the 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 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 Operations 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, and perform quality control to mitigate risk.
Oversee development, enhancement and maintenance of MAP iEnvision, dashboards and tools.
About You
Experience: 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 bridge between different fields of expertise, proactive troubleshooting, and risk management (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.
Role model Sanofi Leadership Frame
Strategic thinking: disrupt the status quo with innovation while remaining pragmatic and focused on priorities.
Result orientation: develop and execute optimal strategy meeting corporate objectives, while creating pragmatic solutions. Comfortable with ambiguity and able to adapt with agility, take calculated risks and anticipate issues.
Leadership: lead through influence, inspire teams, engage and leverage strengths. Set high standards, proactively communicate, collaborate and provide coaching and support.
Relationships and Influence: empower others to build strong relationships and networks. Effective stakeholder management and teamwork.
Take the Lead: Be Bold, Act for Patient, Aim Higher and Lead Together.
Skills and Competencies
Strong leadership and facilitation skills; excellent interpersonal communication in English (written and verbal); well organized with strong time management and the ability to manage multiple projects.
Excellent stakeholder management skills.
Exceptional communication skills with ability to articulate technical concepts to diverse audiences; strong data analytics and content development skills.
Change management expertise with proven success in driving adoption of new technologies.
Proficiency in Excel, PowerPoint, project management tools (Jira, Smartsheet, PowerBI) and AI tools.
Ability to act with urgency.
Track record of successful implementation of innovative solutions that deliver measurable business impact.
Education
Degree in scientific discipline (PhD, PharmD, MD or related scientific master’s degree).
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Grow your talent and career opportunities, including promotions or lateral moves, domestically or internationally.
Enjoy a thoughtful rewards package that recognizes your contribution and amplifies your impact.
Benefit from health and wellbeing programs including extensive parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. US and Puerto Rico Residents Only North America Applicants Only The salary range for this position is: $148,500.00 - $214,500.00. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the provided links.
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Global Senior Manager Early Access Programs Location:
Cambridge, MA or Morristown, NJ About the Job
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 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. About Sanofi
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. Main 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, ensuring compliance and maintaining the portfolio overview and oversight while 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 TA portfolio reviews & mitigation meetings, keeping global medical, local stakeholders and alliance partners updated and informed of 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 the 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 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 Operations 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, and perform quality control to mitigate risk.
Oversee development, enhancement and maintenance of MAP iEnvision, dashboards and tools.
About You
Experience: 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 bridge between different fields of expertise, proactive troubleshooting, and risk management (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.
Role model Sanofi Leadership Frame
Strategic thinking: disrupt the status quo with innovation while remaining pragmatic and focused on priorities.
Result orientation: develop and execute optimal strategy meeting corporate objectives, while creating pragmatic solutions. Comfortable with ambiguity and able to adapt with agility, take calculated risks and anticipate issues.
Leadership: lead through influence, inspire teams, engage and leverage strengths. Set high standards, proactively communicate, collaborate and provide coaching and support.
Relationships and Influence: empower others to build strong relationships and networks. Effective stakeholder management and teamwork.
Take the Lead: Be Bold, Act for Patient, Aim Higher and Lead Together.
Skills and Competencies
Strong leadership and facilitation skills; excellent interpersonal communication in English (written and verbal); well organized with strong time management and the ability to manage multiple projects.
Excellent stakeholder management skills.
Exceptional communication skills with ability to articulate technical concepts to diverse audiences; strong data analytics and content development skills.
Change management expertise with proven success in driving adoption of new technologies.
Proficiency in Excel, PowerPoint, project management tools (Jira, Smartsheet, PowerBI) and AI tools.
Ability to act with urgency.
Track record of successful implementation of innovative solutions that deliver measurable business impact.
Education
Degree in scientific discipline (PhD, PharmD, MD or related scientific master’s degree).
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Grow your talent and career opportunities, including promotions or lateral moves, domestically or internationally.
Enjoy a thoughtful rewards package that recognizes your contribution and amplifies your impact.
Benefit from health and wellbeing programs including extensive parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. US and Puerto Rico Residents Only North America Applicants Only The salary range for this position is: $148,500.00 - $214,500.00. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the provided links.
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