Senior Program Leader, Early-Stage

Sanofi • Cambridge, MA

2d

About The Position

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Our Team The strategic vision of Sanofi’s Global Medical Device and Packaging organization is to lead the industry in device-mediated therapies, with the ambition to develop, launch and maintain best-in-class drug-delivery systems and connected medical devices that address patient unmet needs and improve health outcomes. Our specific mission is to support R&D and the Sanofi Commercial Business Units by delivering differentiated technology solutions that enhance the value of our drugs and vaccines and help patients (and health care providers) facilitate administration, thereby improving their quality of life and empowering them to take control of their disease. Our products and solutions sit on top of our market leading technology platforms, are user-centric, innovative, environmentally sustainable, producible in high quantities and are continuously improved to meet evolving needs. Innovation and new device development are critical pillars for ensuring our continued success to accomplish our missions. As Senior Program Leader in the Early-Stage Portfolio you will lead device development to achieve clinical readiness and transition it to full commercial development programs. You will be responsible for concept development of innovative medical device technologies, from ideation to proof of concept, in order to de-risk late-stage development programs and position us for the future. You will be a key member of Strategy and Innovation Early Stage team to interface with cross-functional teams as single point of contact of the program for Global Device and Packaging Unit (GDPU), solidifying business cases, building development roadmaps and mapping the new device technology solutions with program needs, and be fully responsible for leading all related design and development activities. 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.

Requirements

• Master's or PhD in Mechanical Engineering is required.
• 5+ years’ experience in combination product or medical device development of complex technical products
• Experience in being a technical lead on device development projects
• Experience in design and systems engineering of mechanical and/or electromechanical products
• Strong leadership, communication, and presentation skills
• Capable of capturing unmet needs and translating them into product requirements

Nice To Haves

• Experience in device design from innovation to/or late-stage development is preferred
• Experience with pumps or infusion systems is preferred
• Experience working with research and clinical development teams, solid understanding of related issues and challenges is preferred
• Experience in third party management (design partners, manufacturers and vendors) is preferred
• Experience around regulatory requirements for parenteral combination products is preferred (21 CFR parts 4 & 820, ISO 13485, 14971 & IEC 62366) is preferred
• Strong knowledge of the US/EU external device-mediated drug delivery technology innovation eco-system is preferred
• Solid experience in technology development through external partnership with third parties is preferred
• Experience in SolidWorks and design is preferred
• International business experience leading multicultural and / or multinational team(s)
• Play to win mindset
• Extensive experience with successfully influencing and rapid decision making in matrix and / or governance driven environments
• Attention to details with meticulous planning

Responsibilities

• Lead and facilitate new device development and technology innovation based on clinical and patient needs, commercial and operational requirements and industry trends, create impactful solutions to expand Sanofi device IP portfolio and strength.
• Lead external and internal project teams to develop new devices and product solutions
• Lead the development of new devices and ensure rigorous testing to validate the performance and safety into the final combination products.
• Manage required studies and impact assessment by working with internal and external partners and stakeholders to establish technical and commercial feasibility
• Advance novel technology and product concepts to be clinical ready and create full development roadmap
• Embedded into cross-functional program teams serving as the single point of contact for device programs
• Align with key stakeholders on the selected device solution to meet clinical program needs
• Generate the integrated development plan and resource needs
• Manage all device related development activities to ensure on-time, on-budget execution
• Provide support and leadership in due diligence efforts involving novel device technologies

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level