Job Title: Lead, Sr. Director - In-Vitro Diagnostics Development

Location: Cambridge, MA - Bridgewater, NJ

About the job

The strategic vision of Sanofi's Global Device & Packaging Unit is to lead the industry in device-mediated therapies with the ambition to develop, industrialize and maintain best-in-class drug-delivery systems, connected medical devices and in-vitro diagnostic platforms that are user-centric, innovative, environmentally sustainable, and enhance the value of the drug, in order to help patients improve their quality of life by empowering them to take control of their disease.

Our specific mission is to support the Sanofi business units and R&D by delivering differentiated technology solutions that support administration of drugs and vaccines as well as IVDs that are necessary to develop and commercialize our therapies.

• Drive IVD development strategies tailored to each project, including risk assessments, timeline and budget in collaboration with cross functional project teams including quality and regulatory liaisons.
  
• Execute development programs in collaboration with program leaders that align with the overall clinical plan of specific drug program.
  
• Collaborate with internal stakeholders as well as regulatory teams to develop and plan clinical validation and registration plans for diagnostic products.
  
• Lead as a results-driven influential SME, providing clear, transparent leadership, technical inputs and operational stewardship. Build strong relationships with internal stakeholders at all levels.
  
• Demonstrate strong problem-solving skills, ability to lead under pressure and the ability to influence and drive cross-functional initiatives.
  

• Assess and evaluate potential diagnostic partners for project alignment, technology maturity and operational capability.
  
• Oversee the diagnostic development work conducted by external partners, ensuring alignment with project goals and timelines.
  
• Act as the primary liaison for external diagnostic partners, coordinating development and validation efforts.
  

• Stay informed on industry trends, including advancements in general and companion diagnostics.
  
• Maintain a deep understanding of the regulatory landscape to shape diagnostics strategy for co-developed products.
  

• MS degree in science, engineering or a relevant field
  
• Minimum 12-15 years of Experience within the pharmaceutical/ biotech, medical device, and/or biomarker industry working with In-Vitro Diagnostics (IVD) or Companion Diagnostic (CDx) devices.
  
• Experience working with Companion Diagnostics/ assay development for the pharmaceutical industry.
  
• Understanding of IVD medical device development and applicable Global Regulations related to use of IVDs/CDx and assay development in precision medicine (including EU IVDR, FDA CDx Final Rule).
  
• An understanding of Quality Management Systems (QMS)
  
• Experience with compliance to GxP requirements including the oversight of third-party vendors, suppliers, and partners.
  
• Strong analytical, critical-thinking, decision-making abilities, innovative thinking
  
• Collaborative mindset with an ability to support a high performing team
  

• Ability to commute to Sanofi office location minimum 2 days a week or more as needed.
  
• Ability to travel domestic or internationally up to 20%.
  
• Fluent in English. Basic knowledge of French or German is a plus.
  

• 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.