Global Diagnostic and Scientific Affairs Director

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.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.