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.

• 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.

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

• 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.

• 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.

• 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 andwellness programs and at least 14 weeks' gender-neutral parental leave.