Job Title: Clinical Research Lead
Location: Sanofi Business Operations, India
Organization: Sanofi
About the Team:
Sanofi Business Operations serves as a centralized resource hub to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D. With a commitment to driving innovation and efficiency, this team collaborates globally across medical, HEVA, and commercial organizations to deliver impactful solutions.
Role Overview:
The Clinical Research Lead (CRL) is responsible for the design, implementation, and oversight of clinical research activities. The role involves shaping clinical development plans, ensuring compliance with regulatory standards, and fostering collaboration across diverse teams to advance medical knowledge and enhance patient care.
Key Responsibilities:
Strategic Contributions:
Develop and manage Clinical Development Plans (CDP) and contribute to Integrated Development Plans (IDP).
Shape product value propositions (TVP/TPP) and market access strategies in collaboration with key stakeholders.
Participate in the preparation of Investigator Brochures, Development Safety Update Reports (DSUR), and Drug Risk Management Plans (DRMP).
Study Execution:
Oversee medical input for clinical studies, including training, feasibility assessments, and protocol development.
Ensure accurate and comprehensive medical data review, including adverse event evaluations and safety event coding.
Lead protocol amendments and ensure the development of informed consent documents.
Support patient recruitment and retention strategies.
Data and Document Oversight:
Conduct centralized monitoring activities, including data validation, clinical case reviews, and risk indicator assessments.
Prepare and review critical documents such as Clinical Study Reports (CSR), Clinical Trial Authorization dossiers, and regulatory submissions.
Collaboration:
Partner with internal teams (e.g., Medical Affairs, Biostatistics, Pharmacovigilance) and external stakeholders (e.g., CROs, regulatory agencies).
Establish and manage Adjudication Committees, Steering Committees, and Data Monitoring Committees.
Leadership and Training:
Mentor clinical scientists and ensure effective communication across diverse teams.
Provide insights into emerging trends, challenges, and opportunities within clinical research.
Qualifications and Skills:
Education:
Medical Doctor (MD) required.
Experience:
Extensive background in clinical research and drug development, including experience with Phase 3 trials.
Proficiency in clinical trial methodology, regulatory standards, and ethical guidelines.
Demonstrated expertise in scientific writing, publication, and conference presentations.
Technical Proficiency:
Knowledge of Pulmonary, Allergy, or Immunology therapeutic areas is advantageous.
Strong analytical skills for interpreting clinical trial data and identifying trends.
Familiarity with Good Clinical Practice (GCP) and regulatory requirements.
Soft Skills:
Advanced leadership and mentoring capabilities.
Strong communication, negotiation, and conflict-resolution skills.
Ability to collaborate in a matrixed and multicultural environment.
Languages:
Fluency in English (written and verbal).
Why Join Sanofi?
Impact and Innovation:
Be part of a mission-driven organization that fosters scientific discovery and aims to transform lives through innovative healthcare solutions.
Diversity and Inclusion:
Sanofi values diversity and inclusion, offering a supportive environment where individuals from all backgrounds can thrive.
Professional Growth:
Join a team committed to continuous learning, offering opportunities to lead, innovate, and contribute to groundbreaking clinical research.
Discover More:
Learn about our diversity and inclusion efforts and watch One Day at Sanofi on Sanofi.com.
Pursue progress. Discover extraordinary.
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