Global Diagnostic And Scientific Affairs Director

2+ years

USD 172,500.00 - 249,166.66

Cambridge

10 Oct. 27, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🧪 Global Diagnostic and Scientific Affairs Director

Location: Cambridge, Massachusetts, USA
Job Type: Regular | Posted On: Oct 22, 2025 | Closing On: Jan 1, 2026
Salary Range: USD 172,500 – 249,166.66
Work Mode: #Onsite

🌍 About the Company

Sanofi is a global healthcare leader dedicated to transforming the lives of people with immune challenges, rare diseases, cancers, neurological disorders, and blood disorders. From R&D to commercialization, Sanofi teams collaborate to revolutionize treatments and bring the miracles of science to millions worldwide.

🧬 About the Role

The Global Diagnostic and Scientific Affairs Director will act as a key link between R&D, Therapeutic Areas (TAs), and external laboratory partners, overseeing the development, validation, and implementation of diagnostic assays.
This role requires strong scientific expertise in assay development (ADA, biomarker, and immunogenicity testing), a deep understanding of lab operations, and the ability to lead collaborations and technology transfers globally.

🎯 Key Responsibilities

Serve as the primary liaison between R&D, TAs, and external labs for diagnostic assay development and implementation.
Support and optimize assays (ADA, biomarker, immunogenicity, translational) for clinical and regulatory compliance.
Lead assay transfer from internal teams to external qualified labs, ensuring quality, feasibility, and long-term scalability.
Develop and apply criteria for lab evaluation and selection — including scientific, operational, and compliance factors.
Oversee validation, QC, and troubleshooting with CROs and partner labs.
Collaborate cross-functionally (Regulatory, Clinical, Medical, Commercial) to integrate diagnostic testing into clinical trials and launches.
Design and execute diagnostic strategies supporting global rare disease programs.
Lead negotiations with laboratories to ensure cost-effectiveness and Sanofi standards.
Maintain scientific oversight on assay data interpretation and reporting.
Contribute to publications, presentations, and internal knowledge-sharing.
Mentor and guide junior team members as needed.

🎓 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 (biopharma, CRO, or clinical labs).
Proven expertise in ADA testing, biomarker assays, and immunogenicity assessments.
Experience managing CRO collaborations, QC processes, and lab negotiations.
Solid understanding of laboratory setup and operations.
Strong project management, negotiation, and communication skills.
Experience with regulatory submissions, publications, and cross-functional projects.
Ability to work in a global, matrixed environment managing multiple priorities.

⭐ Preferred Skills

Background in rare disease diagnostics, oncology, or cell/gene therapy testing.
Familiarity with lab audits and quality standards.
Ability to translate complex data into clear strategic recommendations.

💡 Why Join Sanofi

Bring the miracles of science to life in a collaborative, future-focused environment.
Explore global career growth through promotions or international assignments.
Enjoy a comprehensive rewards package that recognizes your impact.
Access a wide range of health and wellbeing programs, including:
- High-quality healthcare
- Prevention & wellness programs
- Minimum 14 weeks of gender-neutral parental leave
Work in an inclusive culture that values diversity and equal opportunity.

⚖️ Equal Opportunity Statement

Sanofi Inc. and its U.S. affiliates are Equal Opportunity Employers committed to diversity and inclusion. All qualified applicants will receive consideration regardless of race, color, religion, sex, national origin, age, disability, gender identity, or any protected characteristic under law.

🚀 Join Us

Be part of Sanofi’s mission to chase the miracles of science and make a global impact on patient lives.
Pursue Progress. Discover Extraordinary. 🌠

Apply Now

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