Senior Program Leader
Sanofi

Job Title: Principal Device Leader

Location: 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.

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.

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.

Within Sanofi`s Global Device and Packaging Unit, the Senior Program Leader will be fully accountable for concurrently developing multiple combination products with low-to-medium technical maturity and high complexity, spanning from the Target Device Profile to launch readiness. This includes project scoping and budget development; key-stake holder management, project planning and scheduling; coordinating and monitoring the work of internal and external teams.

Main Responsibilities:

As Principal Device Leader you will play a pivotal role in leading the development of our products including primary packaging, devices, and packaging. Leadership of multiple, concurrent projects, with significant complexity, size, scope, budget and relying on major partnership(s) is typical for this role.

You will lead the cross-functional Device Project Core-Team and external partners assigned to the project to develop a robust device project strategy addressing essential aspects of product and process engineering, project management, quality (this includes establishment of a Design History File according to 21CFR820 and ISO13485 as needed etc.) and regulatory.

You will partner directly with the Global Project Head, business, CMC key stakeholders, suppliers and within M&S (MED, ICF, DNO, MSAT) to ensure robust and aligned clinical, marketing, and regulatory strategies. You will represent GDPU for the project 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.

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 M&S senior leadership to deliver device and packaging technologies that enhance the value of the drug and provide competitive advantage. You will be fully empowered to act on behalf of GDPU with authority over assignments and will perform independently under broad policy guidance.

You will also

• Define product vision; analyze market, the users, and the roadmap for the product.
• Translate the overall project strategy into a device development plan (scope, schedule, resources, budget (Supplier Selection, and Industrialization Equipment) and execute accordingly.
• Be accountable to define and deliver device development and industrialization program along agreed milestones, budgets, and product quality (Initiate, plan, execute, monitor and control). You perform independently under broad policy guidance.
• Analyze and report project risks, variations and establish mitigation plans.
• Ensure device related-aspects are prepared and managed for clinical studies with device-mediated delivery including preparation of instructions for use, establishment of process for handling of technical complaints, provision of user training, as well as alignment of device-related data collection and study measures.
• Set a high bar for team to push the boundaries, by balancing risk with rigor to optimize and scale development projects based on scope, complexity and risk. Develop key KPIs to drive performance excellence and improvements through management of budget, schedule delivery, and scope. It is expected that you are a leader in Thoughtful Risk Taking for your team(s), with engagement in multi-level stakeholders across Sanofi as appropriate to lead development.
• Lead partnership / relationship with external partners in the development of combination products, representing Sanofi's interests. This involves partnering with Business Development, Alliance Management, preparing for Joint Governance meetings and fully aligning strategy with CMC and Global Project teams.
• Develop a strong network and partnership with Manufacturing & Supply, External Partners, Quality, Regulatory, Supply Chain, Procurement, Commercial, and ensure strong stakeholder ties and management by influencing and ensuring fluid communication regarding project objectives, priorities, progress, and critical issues.

About you:

Education:

• Advanced degree in Science or Engineering (mechanical, electromechanical, medical technology, plastics, physics, or related field) or equivalent.

Experience:

• 12+ years of relevant experience in medical device or combination product development, industrialization or manufacturing, in vitro diagnostics, drug delivery.
• Including 8+ years in the pharmaceutical, biotechnology or medical device industry.
• Demonstrated leadership experience in managing cross-functional teams in bringing medical devices and combination products from concept to commercialization.
• International leadership and business experience in required.
• Experience with establishing and managing of activities at third party manufacturers, vendors and/or with partnerships in a global environment is required.
• Solid Knowledge of key regulatory requirements in the industry (21 CFR parts 4 & 820, ISO13485 and other related industry standards)
• Experience with regulatory agencies or notified bodies, e.g., FDA, EMA or TUEV
• Experienced and qualified in project management activities (e.g., PMP) preferred.
• Experienced in operational and financial responsibilities as well as resource allocation for on time and on budget delivery.

Soft Skill & Technical Skills:

• Successful leader who possesses strong interpersonal and influence management skills with ability to work effectively in a complex, matrixed global organization, leveraging solid influencing and collaboration skills.

• Ability to think strategically, creatively, and purposefully while managing multiple projects.
• Strong technical aptitude technical judgement. Ability to anticipate risks and challenges and guide team to develop strategic solutions to overcome or prevent obstacles in the development process.
• Strong business acumen and ability to evaluate changing business conditions and effectively shift strategy and priorities based on dynamics.

Languages: Fluent in English. Basic knowledge of French or German is a plus.

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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