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Clinical Research Lead

0-2 years
Not Disclosed
10 April 11, 2025
Job Description
Job Type: Full Time Education: MD 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

Hiring Manager: Head Scientific Communications
Location: Hyderabad, India
Travel Requirement: As per business needs
Job Type: Permanent, Full-time
Company: Sanofi
Department: Scientific Communications / Clinical Research


About the Team:

Sanofi Business Operations (SBO) is a strategic internal global hub in India supporting functions across Specialty Care, Vaccines, General Medicines, Consumer Healthcare, Contract Manufacturing, R&D, and Data & Digital. SBO enables delivery for global Medical, HEVA, and Commercial organizations.


Main Responsibilities:

  • Lead and manage clinical trial activities, ensuring compliance with regulatory and organizational requirements.

  • Contribute to strategic plans: Clinical Development Plan (CDP), Integrated Development Plan (IDP), Target Product Profile (TPP), and more.

  • Support clinical studies through medical training, feasibility assessment, data review, and scientific communication.

  • Provide medical responses to Health Authorities, Ethics Committees, and investigators.

  • Perform medical review of safety events, participate in Centralized Monitoring activities, and ensure data quality.

  • Develop clinical study documents: protocols, amendments, consent forms, investigator brochures, CSRs, Lay Summaries, and CTD sections.

  • Oversee processes such as code-breaking, IVRS setup, central reading input, and CAP approval.

  • Lead the development and functioning of Adjudication Committees, Steering Committees, and DMCs.

  • Collaborate with internal stakeholders: Biostatistics, Regulatory Affairs, Pharmacovigilance, CROs, Global Clinical Leads, and Medical Affairs.

  • Prepare medical presentations and participate in investigator meetings.

  • Manage and mentor clinical scientists and ensure effective cross-functional communication.


Required Experience:

  • Strong scientific and clinical expertise.

  • Demonstrated experience in clinical development, ideally with Phase 3 trials.

  • Proficient in protocol design, safety and efficacy data interpretation, and regulatory compliance.

  • Experience in scientific writing, publications, and stakeholder engagement.


Soft Skills:

  • Effective trainer and communicator in cross-functional and international environments.

  • Advanced leadership and negotiation skills.

  • Strong interpersonal, conflict resolution, and decision-making abilities.

  • Open-minded and adaptable to digital innovation.

  • Ability to work within a matrix model.


Technical Skills:

  • Expertise in Pulmonary, Allergy, Immunology, or equivalent drug development experience.

  • Deep knowledge of relevant literature, clinical landscape, and competitor data.

  • Capability to challenge norms with a risk-management mindset.

  • Resource negotiation and operational planning skills.


Education:

  • Medical Doctor (MD) degree required


Languages:

  • Fluent English (verbal and written)


Diversity & Inclusion:

Sanofi is an equal opportunity employer committed to building a diverse and inclusive workforce. Watch our ALL IN video and learn more about our actions at sanofi.com.