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    Clinical Research Lead

    Sanofi
    2+ years
    Not Disclosed
    Hyderabad
    10 Nov. 15, 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

    Job Title: Clinical Research Lead

    About the Job

    Our Team:

    Sanofi Business Operations is an internal Sanofi resource organization based in India. We centralize processes and activities to support various divisions such as Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.

    Main Responsibilities:

    The Clinical Research Lead (CRL) will oversee and manage clinical research activities. This role involves designing, implementing, and monitoring clinical trials to ensure regulatory compliance and organizational goals. The ideal candidate will have a robust background in clinical research, strong leadership skills, and a commitment to advancing medical knowledge and patient care.

    • Oversee Clinical Development Plans (CDP), clinical sections of Integrated Development Plans (IDP), product value proposition (TVP), target product profile (TPP), and market access strategies.
    • Provide medical input for clinical studies, including feasibility, medical review, and training.
    • Address medical questions from Health Authorities, IRBs, investigators, and study teams.
    • Lead the medical review of data, safety events, and protocol deviations.
    • Manage Centralized Monitoring activities such as data validation, clinical case reviews, and risk indicators.
    • Oversee clinical protocol creation, amendments, and Informed Consent Document development.
    • Contribute to clinical documents such as Investigator Brochures, Clinical Study Reports, and Regulatory submissions.
    • Collaborate with various stakeholders including feasibility managers, medical writers, pharmacovigilance teams, and biostatisticians.
    • Lead and manage clinical scientists as needed.

    About You

    Experience:

    • Strong scientific and medical/clinical expertise, especially in clinical development and methodologies.
    • Proven track record in clinical development, ideally with Phase 3 experience.
    • Proficiency in protocol development, trial design, and safety and efficacy data analysis.
    • Understanding of GCP guidelines, regulatory requirements, and ethical considerations in clinical research.
    • Experience in presenting study findings, writing scientific publications, and engaging with the scientific community.

    Soft Skills:

    • Advanced leadership skills and the ability to collaborate with diverse internal and external stakeholders.
    • Excellent interpersonal, communication, presentation, and negotiation skills.
    • Strong problem-solving, conflict-resolution, and decision-making abilities.
    • Ability to work effectively in a matrix environment.

    Technical Skills:

    • In-depth knowledge in Pulmonary, Allergy, Immunology, or strong experience in drug development.
    • Ability to critically evaluate clinical data and competitive products.
    • Proficiency in negotiating resources for clinical conduct.
    • Ability to apply new digital solutions to improve clinical operations.

    Education:

    • Medical Doctor (MD)

    Languages:

    • Fluent in English (verbal and written)

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