Job Title: Clinical Research Lead
Company: Sanofi
Location: India
About Sanofi Business Operations
Sanofi Business Operations, based in India, supports various divisions globally, including Specialty Care, Vaccines, General Medicines, CHC, and R&D. This centralized organization drives efficiency in medical, HEVA, and commercial activities, enabling Sanofi's mission to advance healthcare worldwide.
Main Responsibilities
Strategic Oversight:
Develop and implement the Clinical Development Plan (CDP) and provide input for the Integrated Development Plan (IDP).
Contribute to defining the product value proposition (TVP), target product profile (TPP), and market access strategy.
Clinical Study Support:
Provide medical expertise for clinical studies, including protocol development, informed consent creation, and amendments.
Offer training, feasibility analysis, and medical communication support to study teams and stakeholders.
Review and ensure the quality and compliance of clinical trial data, case safety events, and centralized monitoring activities.
Regulatory and Safety Compliance:
Prepare/review essential regulatory documents like the Investigator Brochure, Clinical Study Report, and Clinical Trial Authorization dossiers.
Address queries from Health Authorities, IRBs, and investigators while ensuring adherence to GCP, regulatory standards, and SOPs.
Cross-functional Collaboration:
Work with diverse teams, including biostatisticians, medical writers, pharmacovigilance, and regulatory affairs.
Collaborate with CROs, steering committees, and other stakeholders to drive successful study execution.
Team Leadership:
Mentor clinical scientists and manage team resources.
Provide strategic input and decision-making for trial-related challenges, ensuring adherence to timelines and objectives.
Required Qualifications
Education:
Medical Doctor (MD)
Experience:
Strong background in clinical development with Phase 3 experience preferred.
Expertise in clinical trial methodology, protocol development, and regulatory compliance.
Proven track record of publishing scientific findings and engaging with the medical community.
Skills:
Scientific & Technical:
Deep knowledge of Pulmonary, Allergy, or Immunology, or experience in drug development.
Critical evaluation of competitive medical literature and therapeutic area developments.
Soft Skills:
Advanced leadership, collaboration, and networking skills in a cross-cultural environment.
Strong problem-solving, conflict-resolution, and decision-making abilities.
Excellent teaching, presentation, and negotiation skills.
Technical Proficiency:
Familiarity with centralized monitoring, data quality assessment, and risk indicators.
Open to adopting new digital solutions for operational efficiency.
Language:
Fluent in English (written and spoken).
Why Join Sanofi?
Sanofi is committed to creating better outcomes through groundbreaking science and patient-centered solutions. At Sanofi, you will be part of a global team united by a passion for progress, inclusivity, and innovation.
What We Offer:
An inclusive work environment valuing diversity and equity.
Opportunities to drive meaningful change and contribute to medical advancements.
A global platform to grow professionally and personally.
Watch the 'ALL IN' video and explore Sanofi’s Diversity, Equity, and Inclusion initiatives here.
Be part of the extraordinary. Pursue progress with us.
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