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Clinical Research Lead

3+ years
Not Disclosed
10 April 22, 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

Clinical Research Lead

Job Title:

  • Clinical Research Lead

Hiring Manager:

  • Head Scientific Communications

Location:

  • Hyderabad, India

% of Travel Expected:

  • Travel required as per business need

Job Type:

  • Permanent, Full-time

About the Job:
At Sanofi, you will contribute to a diverse and growing portfolio, working on established medicines and pioneering innovations in immunology and chronic disease care. With a focus on leveraging AI and digital tools, Sanofi is accelerating innovation and expanding healthcare access globally.

Our Team:
Sanofi Business Operations is an internal organization supporting various Sanofi divisions including Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D. It serves as a strategic partner for delivering tactical solutions across Medical, HEVA, and Commercial organizations globally.

Main Responsibilities:

  • Oversee and manage clinical research activities, ensuring compliance with regulatory requirements and organizational goals.

  • Strategize Clinical Development Plan (CDP), Integrated Development Plan (IDP), Target Value Proposition (TVP), Target Product Profile (TPP), and market access strategies.

  • Provide medical support for clinical study activities, including training, feasibility assessment, data review, and communication with stakeholders.

  • Respond to Health Authorities, IRB/Ethics Committees, Investigators, and study teams with appropriate medical information.

  • Conduct medical review of clinical trial data and contribute to centralized monitoring activities.

  • Develop and amend protocols, informed consent documents, Investigator Brochures, Clinical Study Reports, regulatory submissions, and publications.

  • Collaborate cross-functionally with stakeholders including feasibility managers, medical writers, medical affairs, pharmacovigilance, biostatistics, regulatory affairs, and CROs.

  • Manage clinical scientists, if required, and ensure high-quality clinical trial execution.

About You:

Experience:

  • Robust scientific and clinical expertise with proficiency in clinical development and study methodologies.

  • Demonstrated experience in Phase 3 clinical development preferred.

  • Experience in scientific publications, conference presentations, and scientific community engagement.

  • Skilled in protocol development and ensuring regulatory and ethical compliance.

  • Strong capability in clinical trial data interpretation, safety, efficacy analysis, and decision-making based on data.

  • Proficient knowledge of Good Clinical Practice (GCP) and regulatory requirements for clinical trials.

Soft Skills:

  • Effective training and communication capabilities.

  • Advanced leadership skills and ability to collaborate with cross-functional, international teams.

  • Strong interpersonal, networking, presentation, and negotiation skills.

  • Focused on performance, strategy execution, problem-solving, conflict resolution, and decision-making.

  • Excellent teaching and mentoring abilities.

  • Adaptable to matrix working models and open to implementing digital solutions.

Technical Skills:

  • Deep scientific and clinical knowledge in Pulmonary, Allergy, or Immunology, or strong drug development expertise.

  • Strong analytical capabilities for reviewing scientific literature and competitive landscape.

  • Ability to maintain visibility and credibility within therapeutic areas.

  • Risk-management mindset for challenging status quo and negotiating resources.

Education:

  • Medical Doctor (MD)

Languages:

  • Fluent in English (verbal and written)

Commitment to Diversity and Inclusion:
At Sanofi, we believe better outcomes come from diverse teams. We are committed to creating an inclusive environment where people from all backgrounds can thrive.

How to Apply:

  • Apply now through the Sanofi Careers website.