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    Clinical Research Director

    Sanofi
    7+ 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 Research Director - Sanofi
    Location: Cambridge, MA

    About the Job
    Are you ready to shape the future of medicine? Sanofi is driving the race to accelerate drug discovery and development, and your expertise could be key to helping our teams make a difference for patients and their families.

    The Clinical Research Director (CRD) is a primary clinical expert for the programs they lead. This strategic and operational role requires a highly organized, resourceful, and self-motivated individual with excellent emotional intelligence, analytical skills, and the ability to manage multiple operational tasks effectively.

    The CRD will:

    • Lead the execution of clinical studies at both strategic and operational levels.
    • Be responsible for medical documentation related to clinical studies (e.g., protocols, clinical study reports).
    • Contribute to the program lifecycle strategy, including new indication selections.
    • Report to the Global Project Head and collaborate with other CRDs and stakeholders, ensuring alignment across functions such as pharmacovigilance and regulatory affairs.

    We are an innovative, global healthcare company with one purpose: to chase the miracles of science to improve people's lives. At Sanofi, you’ll have countless opportunities to grow your career, make connections, and push the limits of what you thought was possible. Ready to get started?

    Main Responsibilities:

    • Lead clinical development strategies: Develop clinical development plans and clinical sections of integrated development plans (IDPs), and contribute to key result preparations.
    • Collaboration and leadership: Coordinate with other CRDs, resolve project-related study issues, and share lessons learned across project or study teams.
    • Medical input and strategy: Contribute to defining the product value proposition (TVP), target product profile (TPP), market access strategy, and focus of the research strategy.
    • Study management: Lead and oversee the execution of clinical development activities, including protocol creation, amendments, and clinical study reports.
    • Data and safety review: Continuously review aggregated data during clinical trials and ensure timely medical reviews of safety, statistical outputs, and blinded data.
    • Regulatory and safety documentation: Contribute to clinical sections of documents such as Investigator’s Brochures, CTAs, INDs, DSURs, and DRMPs, ensuring regulatory compliance.
    • Operational leadership: Manage timelines, budgets, and contingency plans with operational support to ensure successful trial execution in compliance with GCP, laws, and SOPs.
    • External collaborations: Build relationships with external partners, regulators, and internal stakeholders to ensure optimal study execution.
    • Scientific data contribution: Participate in manuscript and abstract authorship, advisory board planning, and clinical evaluations for potential in-licensing candidates.

    About You

    Experience & Skills:

    • Over 3 years of experience in pharmaceutical or CRO environments, with expertise in clinical development and methodologies.
    • Strong scientific and medical expertise, with excellent communication skills for interaction with internal teams and regulatory agencies.
    • Ability to challenge decisions and the status quo using a risk-management approach.
    • Experience with negotiation, resource allocation, and working in a matrix organization.
    • Fluency in written and spoken English and experience in international, intercultural settings.
    • Open-mindedness to adopt new digital solutions for clinical research.

    Education:

    • Medical Doctor (MD) preferred (GP or specialist).

    Why Choose Us?

    • Bring the miracles of science to life alongside a supportive, future-focused team.
    • Discover endless opportunities for career growth, including promotions or lateral moves within Sanofi.
    • Enjoy a comprehensive rewards package that recognizes your contributions, including health and wellness benefits and generous parental leave.
    • Sanofi Inc. is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce.

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