Clinical Research Lead

5+ years

Not Disclosed

Hyderabad

10 Dec. 13, 2024

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
Location: Sanofi Business Operations, India
Job Type: Full-time, Permanent

About Sanofi Business Operations

Sanofi Business Operations is an internal organization designed to centralize processes and activities across various Sanofi functions, including Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, Data & Digital. This team aims to act as a strategic partner for the global Medical, HEVA, and Commercial organizations, enabling the seamless execution of business operations globally.

Main Responsibilities

As the Clinical Research Lead (CRL), you will be responsible for overseeing and managing clinical research activities, including the design, implementation, and monitoring of clinical trials. This role is key to ensuring regulatory compliance, advancing medical knowledge, and supporting patient care.

Strategic Responsibilities
- Lead the preparation of Clinical Development Plans (CDP) and contribute to Integrated Development Plans (IDP), product value proposition (TVP), and market access strategies in collaboration with relevant functions.
- Contribute to the preparation of Investigator Brochures (IB), Development Safety Update Reports (DSUR), and Drug Risk Management Plans (DRMP).
Medical Support for Clinical Studies
- Provide medical input to clinical studies including medical training, feasibility assessments, and medical review of data.
- Review safety events and coding of events/drugs and provide medical answers to queries from Health Authorities, IRBs/Ethics Committees, Investigators, and study teams.
Clinical Data Review and Centralized Monitoring
- Oversee the centralized monitoring activities, including review of adverse events, patient data validation, and data quality assessments.
- Lead the medical review of clinical data, protocol deviations, and key risk indicators (KRI) for quality and compliance.
Protocol and Study Document Management
- Lead protocol creation, amendments, and development of Informed Consent documents.
- Contribute to clinical study documents such as Clinical Study Reports, Investigator Brochures, Regulatory submissions, and publications.
Collaboration and Stakeholder Engagement
- Work closely with various cross-functional teams, including feasibility managers, medical writers, pharmacovigilance, biostatisticians, and external partners such as CROs and regulatory affairs.
- Set up and manage Adjudication & Steering Committees, Data Monitoring Committees, and provide oversight in clinical trial execution.
Leadership and Team Management
- Manage and mentor clinical scientists and team members involved in clinical trials.
- Communicate effectively with internal and external stakeholders to ensure optimal study execution.
Compliance with GCP and Regulations
- Ensure that clinical studies comply with Good Clinical Practice (GCP), applicable laws, and standard operating procedures (SOPs).
- Monitor the recruitment, retention, and progress of clinical trials.

About You

Experience & Expertise

Clinical Development Expertise: Demonstrated experience in clinical development with a focus on protocol development, clinical trial design, and execution, especially in Phase 3 studies.
Scientific and Medical Expertise: Strong background in medical and clinical science, with proficiency in interpreting clinical data and ensuring regulatory and ethical compliance in clinical trials.
Publications & Presentations: Experience in writing scientific publications and presenting clinical findings at conferences.
Experience in Drug Development: Knowledge of therapeutic areas such as Pulmonary, Allergy, Immunology, or similar fields is an advantage.

Soft Skills

Leadership & Collaboration: Strong leadership skills with a focus on collaboration across internal and external teams, stakeholders, and regulatory bodies.
Communication Skills: Excellent interpersonal, communication, and negotiation skills with the ability to lead diverse teams and maintain strong relationships.
Problem-Solving & Decision-Making: Ability to resolve conflicts, make data-driven decisions, and manage risks effectively.
Training & Mentoring: Ability to train and mentor team members and stakeholders in clinical development practices.

Technical Skills

Clinical Knowledge: Deep understanding of clinical trial design, data analysis, regulatory guidelines, and medical literature.
Therapeutic Area Knowledge: Expertise in areas such as Pulmonary, Allergy, or Immunology, with the ability to stay up-to-date with preclinical, translational, and clinical data.
Digital Solutions: Open-mindedness to applying new digital solutions in clinical trials and development processes.

Education & Language Requirements

Education: Medical Doctor (MD) or equivalent qualification in a relevant field.
Languages: Fluency in English (both verbal and written) is required.

Why Sanofi?

Sanofi offers a dynamic and inclusive work environment where you can contribute to meaningful progress in the healthcare industry. As a part of our team, you’ll have the opportunity to work on innovative clinical trials and collaborate across diverse teams to improve patient care.

Inclusive Culture: We believe in equal opportunities for all and encourage people from diverse backgrounds to join our team.
Growth Opportunities: At Sanofi, we provide a wide range of opportunities for professional development, and we are committed to helping you grow your career.
Health & Well-being: We offer competitive compensation, health benefits, and wellness programs to ensure that our employees feel supported both personally and professionally.

Pursue Progress. Discover Extraordinary.
At Sanofi, we provide equal opportunities to all, regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Explore our Diversity, Equity, and Inclusion initiatives at sanofi.com and watch our ALL IN video to learn more about our inclusive work culture.

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