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.

Global Senior Manager Early Access Programs sits within Specialty Care ManagedAccess Programs (MAP) and Cross-GBU On Demand Import License (ODIL) OperationsMAP 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.

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 always ensuring complianceand maintain 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 Manger 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

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 successfully bridge between different fields of expertise, proactive troubleshooting managing 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, communicates proactively, collaborative and approachable and ability to 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.

Skillsand Competencies:

• Strong leadership and facilitation skills. Strong interpersonal communication skills (in 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 with 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, PowerBi, 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 masters 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.

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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.