Sanofi
Global Senior Manager Early Access Programs
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. The Global Senior Manager Early Access Programs sits within Specialty Care Managed Access Programs (MAP) and Cross‑GBU On‑Demand Import License (ODIL) Operations MAP, designed to help patients with serious or life‑threatening conditions access investigational products when they don’t respond to or tolerate approved therapies and when they are not eligible to participate in a clinical trial.
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, maintaining portfolio oversight and optimizing resource allocation.
Provide continuous improvement and process simplification for organizational efficiency and effectiveness, driving excellence in execution of MAP programs & PRIL.
Ensure global & local structured programs have 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 to implementation.
Act as Senior Global Manager of MAP operations and 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 for structured programs at program and portfolio level, ensuring operational excellence, end‑to‑end visibility and adherence to agreed operational KPIs.
Set up a program‑level end‑to‑end patient treatment accountability and program reporting.
Provide periodic updates on R&D pipeline and proactive MAP 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 topics with vendors (e.g., supply quality, forecast, logistics, inventory, cold chain, shelf life, distribution) and provide insight into 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 operation team.
Maintain close co‑local 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, performing quality assurance to improve processes, minimize risk, and perform quality control.
Oversee development, enhancement, and maintenance of MAP iEnvision dashboards and tools.
About You
10+ years in the biopharmaceutical industry, expanding roles in Medical, Medical Operations or related fields; experience and understanding of the current pharmaceutical environment; successful management of complex, business‑critical cross‑functional programs; ability to bridge expertise fields; proactive troubleshooting of program risks and challenges (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: ability to disrupt status quo with innovation while remaining pragmatic and focused on priorities.
Result orientation: driven to develop and execute optimal strategy meeting corporate objectives, while creating pragmatic solutions; comfortable with ambiguity and ability to adapt with agility, take calculated risks and anticipate potential issues.
Leadership: ability to lead through influence, inspire teams, engage and leverage everyone’s strengths; set high standards and expectations, communicate proactively, collaborate, be approachable, and provide meaningful feedback, coaching and support.
Relationships and Influence: ability to empower and recognize others to create powerful relationships and networks; effective stakeholder management, politically astute and role model teamwork and collaboration.
Take the Lead: Be bold, act for patient, aim higher and lead together.
Skills And Competencies
Strong leadership and facilitation skills; strong interpersonal communication skills (English, written and verbal); well organized, focused on results, capable of managing multiple projects; excellent time‑management skills with respect to priorities and self‑management.
Excellent stakeholder management skills.
Exceptional communication skills with ability to articulate technical concepts to diverse audiences, using highly developed 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, Power BI, AI tools.
Ability to act with urgency.
Track record of successful implementation of innovative solutions that deliver measurable business impact.
Education
Degree in a 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.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well‑crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high‑quality healthcare, prevention and wellness programs and at least 14 weeks’ gender‑neutral 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.
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in company employee benefit programs, and additional benefits information can be found here.
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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. The Global Senior Manager Early Access Programs sits within Specialty Care Managed Access Programs (MAP) and Cross‑GBU On‑Demand Import License (ODIL) Operations MAP, designed to help patients with serious or life‑threatening conditions access investigational products when they don’t respond to or tolerate approved therapies and when they are not eligible to participate in a clinical trial.
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, maintaining portfolio oversight and optimizing resource allocation.
Provide continuous improvement and process simplification for organizational efficiency and effectiveness, driving excellence in execution of MAP programs & PRIL.
Ensure global & local structured programs have 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 to implementation.
Act as Senior Global Manager of MAP operations and 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 for structured programs at program and portfolio level, ensuring operational excellence, end‑to‑end visibility and adherence to agreed operational KPIs.
Set up a program‑level end‑to‑end patient treatment accountability and program reporting.
Provide periodic updates on R&D pipeline and proactive MAP 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 topics with vendors (e.g., supply quality, forecast, logistics, inventory, cold chain, shelf life, distribution) and provide insight into 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 operation team.
Maintain close co‑local 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, performing quality assurance to improve processes, minimize risk, and perform quality control.
Oversee development, enhancement, and maintenance of MAP iEnvision dashboards and tools.
About You
10+ years in the biopharmaceutical industry, expanding roles in Medical, Medical Operations or related fields; experience and understanding of the current pharmaceutical environment; successful management of complex, business‑critical cross‑functional programs; ability to bridge expertise fields; proactive troubleshooting of program risks and challenges (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: ability to disrupt status quo with innovation while remaining pragmatic and focused on priorities.
Result orientation: driven to develop and execute optimal strategy meeting corporate objectives, while creating pragmatic solutions; comfortable with ambiguity and ability to adapt with agility, take calculated risks and anticipate potential issues.
Leadership: ability to lead through influence, inspire teams, engage and leverage everyone’s strengths; set high standards and expectations, communicate proactively, collaborate, be approachable, and provide meaningful feedback, coaching and support.
Relationships and Influence: ability to empower and recognize others to create powerful relationships and networks; effective stakeholder management, politically astute and role model teamwork and collaboration.
Take the Lead: Be bold, act for patient, aim higher and lead together.
Skills And Competencies
Strong leadership and facilitation skills; strong interpersonal communication skills (English, written and verbal); well organized, focused on results, capable of managing multiple projects; excellent time‑management skills with respect to priorities and self‑management.
Excellent stakeholder management skills.
Exceptional communication skills with ability to articulate technical concepts to diverse audiences, using highly developed 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, Power BI, AI tools.
Ability to act with urgency.
Track record of successful implementation of innovative solutions that deliver measurable business impact.
Education
Degree in a 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.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well‑crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high‑quality healthcare, prevention and wellness programs and at least 14 weeks’ gender‑neutral 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.
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in company employee benefit programs, and additional benefits information can be found here.
#J-18808-Ljbffr