Job Title: Clinical Research Lead
Location: Hyderabad, India
Job Type: Permanent
Date Posted: January 3, 2025
Application Deadline: March 31, 2025
About the Job:
Sanofi Business Operations is seeking a Clinical Research Lead (CRL) to oversee and manage clinical research activities within the organization. As part of a dynamic team supporting Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D functions, this role plays a critical part in ensuring clinical trials meet regulatory requirements and organizational goals.
Key Responsibilities:
Strategic Clinical Development:
Oversee the Clinical Development Plan (CDP) and clinical sections of the Integrated Development Plan (IDP).
Contribute to defining the product value proposition (TVP), target product profile (TPP), and market access strategy.
Support the preparation of Investigator Brochures (IB), Development Safety Update Reports (DSUR), and Drug Risk Management Plans (DRMP).
Clinical Trial Management:
Provide medical input for clinical study activities, including feasibility, medical reviews, and data communications.
Respond to health authorities, IRB/Ethics Committees, investigators, and internal study teams.
Lead centralized monitoring activities, such as data validation, risk indicator reviews, and protocol deviation assessments.
Drive recruitment and retention strategies for clinical trials.
Document and Protocol Oversight:
Responsible for the medical content and amendments of clinical trial protocols and informed consent documents.
Prepare and review clinical documents such as Investigator Brochures, Clinical Study Reports (CSR), Lay Summaries, and regulatory submissions (IMPD, IND, CTD).
Contribute to study-specific documents, including Monitoring Plans, Statistical Analysis Plans (SAP), and Data Validation Plans.
Study Operations Support:
Oversee processes such as IVRS setup, central readings, CAP approvals, and database lock activities.
Support health authority inspections, internal audits, and adjudication/steering committees.
Collaborate with internal teams (Medical Writers, Pharmacovigilance, Biostatisticians) and external CROs.
Team Leadership:
Manage and mentor clinical scientists within the team.
Provide training and ensure alignment with global clinical standards and best practices.
Foster a collaborative and performance-driven team environment.
Qualifications:
Education: Medical Doctor (MD) degree is required.
Experience:
Strong scientific and clinical expertise, with a focus on clinical development and study methodologies.
Demonstrated track record in clinical development, with Phase 3 experience being advantageous.
Experience in writing scientific publications and engaging with the scientific community.
Proven ability to develop and oversee clinical trial protocols and interpret safety and efficacy data.
Regulatory Knowledge:
Proficient in good clinical practice (GCP) guidelines and global regulatory requirements.
Key Skills:
Leadership & Communication:
Advanced leadership and mentoring capabilities.
Strong networking skills in a cross-cultural environment.
Excellent communication, presentation, and negotiation abilities.
Problem-Solving:
Strategic, performance-oriented mindset with strong decision-making and conflict-resolution skills.
Technical Expertise:
Deep scientific and clinical knowledge in therapeutic areas such as pulmonary, allergy, or immunology.
Ability to critically evaluate relevant medical literature and maintain visibility within the therapeutic area.
Language: Fluent in English (verbal and written).
Why Join Us?
At Sanofi, we are committed to creating an environment where your talent, creativity, and passion for clinical research will contribute to improving patient lives. We offer competitive benefits, continuous learning opportunities, and a culture that promotes innovation and collaboration.
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