Clinical Research Lead
Location: Hyderabad, India
Job Type: Permanent, Full-time
Travel: As per business needs
About the Role
The Clinical Research Lead (CRL) will oversee and manage clinical research activities, including designing, implementing, and monitoring clinical trials to meet regulatory requirements and organizational goals. This role involves leadership, strategic planning, and close collaboration with internal and external stakeholders to advance medical knowledge and patient care.
Key Responsibilities
Lead development and implementation of Clinical Development Plans (CDP) and clinical sections of Integrated Development Plans (IDP).
Support product value proposition, target product profile (TPP), and market access strategies.
Contribute to Investigator Brochure (IB), Development Safety Update Reports (DSUR), and Risk Management Plans (DRMP).
Provide medical input for clinical study activities including feasibility, medical review, training, and communication with study teams and stakeholders.
Respond to medical queries from Health Authorities, IRBs/Ethics Committees, investigators, and experts.
Oversee medical review of clinical trial data, safety event evaluations, and coding of events/drugs.
Lead centralized monitoring activities including adverse event review, data validation, protocol deviations, and key risk indicators.
Support patient recruitment and retention strategies.
Develop and amend clinical trial protocols and informed consent documents.
Prepare clinical documents such as regulatory briefing packages, clinical study reports, and clinical trial authorization dossiers.
Contribute clinical input to study documents like CRFs, e-diaries, monitoring plans, and statistical analysis plans.
Coordinate protocol-related processes such as code-breaking, IVRS setup, and database lock activities.
Prepare medical presentations and participate in investigator meetings.
Establish and manage adjudication, steering, and data monitoring committees as applicable.
Collaborate across functions (medical affairs, biostatistics, pharmacovigilance, regulatory, CROs) to ensure compliant and effective study execution.
Manage clinical scientists within the team as needed.
Required Qualifications & Experience
Medical Doctor (MD) degree.
Strong clinical and scientific expertise in drug development and clinical research methodology.
Proven experience in clinical development, preferably with Phase 3 trial experience.
Skilled in protocol development and interpretation of clinical trial data.
Knowledge of good clinical practice (GCP), regulatory requirements, and ethical standards.
Experience in writing scientific publications and presenting clinical data.
Skills & Competencies
Excellent leadership and communication skills.
Ability to work effectively in cross-cultural and matrix environments.
Strong problem-solving, negotiation, and conflict-resolution abilities.
Capability to train and mentor colleagues.
Familiarity with digital tools and new technologies applied in clinical research.
Proficiency in English (verbal and written).
Networking skills across internal and external stakeholders.
Preferred Therapeutic Expertise
Experience in Pulmonary, Allergy, Immunology, or other relevant therapeutic areas.
Up-to-date knowledge of clinical and pre-clinical data for related compounds and therapies.
Sanofi is an equal opportunity employer committed to diversity and inclusion.
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Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Frank Scottile Blvd |Missouri :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Canada |Quebec :
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Greece |North Island :
Auckland |New Zealand :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
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Ho Chi Minh City |Italy :
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Rho |Jakarta :
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Surabaya |Japan :
Japan | Saitama |Tokyo :
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Tel Aviv | Yavne | Netanya | Kfar Saba | Be'Er Sheva |Remote :
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New Mexico | Ciudad de México |Dubai :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
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