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    Senior Clinical Scientist, Neurology

    Sanofi
    5+ years
    Not Disclosed
    Cambridge
    10 Dec. 10, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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

    Clinical Development Scientist, Neurology
    Location: Cambridge, MA

    About the Job
    At Sanofi, our purpose is clear: to chase the miracles of science and improve people’s lives. We are committed to innovation, and we believe in creating an environment where you can thrive, grow, and explore the limitless possibilities of your career. Join us and be part of a company that is reshaping the future of healthcare.

    As a Clinical Development Scientist (CDS) in Neurology, you will collaborate with a diverse team of experts across clinical development, regulatory affairs, medical affairs, safety, and external key opinion leaders (KOLs). In this role, you will support the development of strategies and documents related to compound development, regulatory interactions, and post-commitment studies while gaining deep expertise in neurology and experimental therapies.

    Main Responsibilities

    • Collaborate with development physicians to prepare materials for Advisory Boards and meetings with Regulatory Affairs.
    • Conduct literature reviews to identify and evaluate external opportunities.
    • Assist in the review of clinical study country lists, aligning with Medical Affairs and Commercial teams on business cases for each country.
    • Compile regulatory, launch, and reimbursement status in collaboration with the regulatory, commercial, and market access teams.
    • Work closely with project teams, including clinical pharmacology, safety officers, biostatistics, and regulatory teams to ensure the timely preparation of deliverables.
    • Contribute to clinical sections of protocols, study reports, regulatory updates, and other essential documents.
    • Participate in scientific publication and communication reviews to ensure data accuracy.
    • Support the preparation of presentations for key committees (e.g., BRAC, TARC, GPTM).
    • Engage in Global Program level meetings to facilitate project advancement.

    Requested Profile

    • Education: A scientific medical degree (PhD) with over 10 years of experience in the pharmaceutical industry, including roles in both R&D and Medical Affairs.
    • Experience: Proven experience in KOL interactions, data review and interpretation, and manuscript/abstract preparation.
    • Knowledge of Pharmacovigilance, CMC landscape, and project planning tools.
    • In-depth understanding of the clinical research process, from program planning to regulatory submission.

    Professional and Behavioral Competencies

    • Strong ability to coordinate and prioritize activities, identify and resolve issues, and motivate teams toward achieving project milestones and delivering quality data.
    • Proven experience working in a global, cross-functional team and navigating an international matrix organization.
    • Excellent communication (oral and written) skills in English, with proficiency in French or a third language being advantageous.
    • Strategic thinking and the ability to synthesize complex information.
    • A team-oriented mindset with strong collaboration and networking skills.

    Why Choose Us?
    At Sanofi, we are committed to bringing the miracles of science to life. As part of our future-focused team, you’ll have the opportunity to grow your talent, explore new career paths, and make a meaningful impact on healthcare. We offer a thoughtful rewards package, comprehensive health benefits, wellness programs, and generous parental leave.

    Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. We encourage all qualified individuals to apply regardless of race, color, creed, religion, national origin, age, gender identity, sexual orientation, disability, or other characteristics protected by law.

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