**Job Title:** Global Diagnostic and Scientific Affairs Director **Location:** Cambridge, MA **About the Job** We are seeking a highly motivated and scientifically skilled professional to join the Global Diagnostics & Scientific Affairs team. This individual will serve as the key interface between R&D, Therapeutic Areas (TAs), and external laboratory partners, driving the development, transfer, and implementation of diagnostic assays across multiple platforms. The role requires deep scientific expertise in assay development (with strong emphasis on ADA and biomarker testing), a solid understanding of laboratory capabilities and set-up, and strong cross-functional collaboration skills. The successful candidate will also contribute to establishing lab selection criteria, overseeing technology transfer, and leading negotiations with external partners to ensure robust and scalable diagnostic solutions. We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. **Main Responsibilities** + Act as primary liaison between R&D, TAs, and external laboratories to ensure alignment on diagnostic assay development, validation, and implementation. + Support the development and optimization of assays (e.g., ADA, biomarker, immunogenicity, and exploratory translational tests) to meet clinical and regulatory needs. + Lead the transfer of assays from internal development to qualified external laboratories, ensuring quality standards, feasibility, and sustainability. + Establish comprehensive criteria and frameworks for laboratory evaluation and selection, including scientific, operational, quality and compliance capabilities. + Partner with external CROs/labs to manage test validation, QC processes, and troubleshooting. + Collaborate cross-functionally with regulatory, clinical, medical, and commercial teams to integrate diagnostic testing into clinical trial and product launch strategies. + Contribute to the design and execution of diagnostic strategies supporting global rare disease programs. + Drive effective negotiations with laboratories and partners to ensure cost-effectiveness and alignment with Sanofi’s standards. + Maintain strong scientific oversight on assay development, data interpretation, and reporting for internal and external stakeholders. + Contribute to scientific publications, presentations, and knowledge sharing. + Provide mentorship and training to junior team members as needed. **About You** **Qualifications & Experience** + PhD, PharmD, or MS in Immunology, Molecular Biology, Translational Science, or related field. + 2+ years of experience in translational research, assay development, or diagnostics within biopharma, CRO, or clinical laboratories. + Strong expertise in assay development, validation, and transfer — particularly ADA testing, biomarker assays, and immunogenicity assessments. + Demonstrated experience managing collaborations and negotiations with CROs and external labs, including QC oversight and troubleshooting, highly preferred. + Solid understanding of laboratory set-up, capabilities, and technical operations. + Excellent negotiation, project management, and cross-functional communication skills. + Experience contributing to regulatory submissions, publications, and cross-functional scientific projects. + Ability to thrive in a global, matrixed environment and manage multiple priorities. **Preferred Skills** + Knowledge of rare disease diagnostics/oncology and/or cell and gene therapy testing. + Familiarity with laboratory audits and quality standards. + Demonstrated ability to translate complex scientific data into clear recommendations for decision-making & strategy. **Why Join Sanofi:** At Sanofi, we are dedicated to making a difference in patients' lives through innovative healthcare solutions. We offer a dynamic and inclusive work environment, opportunities for professional growth, and a commitment to work-life balance. Join us and be part of a team that is transforming the future of diagnostics. **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 a 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. \#GD-SG \#LI-GZ \#Onsite \#vhd **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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. _North America Applicants Only_ The salary range for this position is: $172,500.00 - $249,166.66 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) . Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)