Senior Program Leader

Job Title: Senior Program Leader

Location: Morristown, NJ or Cambridge, MA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. 

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.   

We continue to recruit top talent in the industry to help transform the standard of care in the areas of drug delivery devices and stand-alone medical devices.  Our teams have developed and released to market auto-injectors, pens, safety syringes, as well as connected medical device technologies and we are in a mode to continue ramp up the volumes and re-new with industry standard and innovative solution our device manufacturing capacities.

Within Sanofi`s Global Device and Packaging Unit, as senior program leader you will play a pivotal role in leading programs covering all aspects of device and packaging (primary and secondary) for your products, either in development or in Life cycle management.

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?

Main Responsibilities:

• You will lead a cross-functional team which combines multidisciplinary functions, including GDPU and GDPQ, QA/RA, M&S Site and global functions, MSAT, CMC teams and external partners, assigned to the program. 

• With your team members, you will build and deploy a robust product strategy, addressing essential aspects related to Device and Packaging of the pharmaceutical product, and process engineering, project/program management, quality, regulatory and supply.

• This role requires a strategic thinker with cross-functional perspective, and a deep technical expert who can drive programs from concept to commercialization.  

• This role involves close collaboration with R&D (for development) and M&S (for industrialization and LCM) to deliver device and packaging technologies that enhance the value of the drug and provide competitive advantage. 

• You may   partner directly with the Global Project Head (for development) and/or Industrial Product Leader (for LCM) integrating their team as needed, business, CMC key stakeholders, suppliers and within M&S (M&S Sites, , MSAT) to ensure robust and aligned clinical, marketing, and regulatory strategies. 

• You will represent GDPU for the program in all cross-functional meetings and ensure that strategy, scope, plan, and budget, is fully understood by all stakeholders and aligned in advance of governance body meetings. For projects for which the device component is core, represent GDPU directly, ensuring that device aspects are covered explicitly into a specific section. 

• You may be assigned for LCM as Site Network Coordinator, acting as GDPU reference point for a given network of M&S sites, involved in manufacturing of your products.

You will also:

• Support GPT and IPT to define product vision; analyze market, the users, and the roadmap for the product. 

• Translate the overall project strategy into a product development plan (development scope) or an industrialization, packaging & device performance maintenance plan (LCM scope) with clear scope, schedule, resources, budget (Supplier Selection, and Industrialization Equipment) and execute accordingly.

• Set a high bar for team to push the boundaries, by balancing risk with rigor to optimize and scale program based on scope, comp