Clinical Research Lead

Sanofi

2+ years

Not Disclosed

Hyderabad

10 Dec. 24, 2024

Job Description

Job Type: Full Time Education: MD/DO 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: India (Hyderabad/Mumbai)
Job Type: Permanent, Full-time

About the Job

Our Team:
Sanofi Business Operations is an internal resource organization based in India that centralizes processes and activities to support various functions, including Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, Data & Digital. The team works to support Medical, HEVA, and Commercial teams globally.

Main Responsibilities:

The Clinical Research Lead (CRL) will be responsible for overseeing clinical research activities, including the design, implementation, and monitoring of clinical trials. The CRL will ensure trials meet regulatory standards and align with organizational goals.

Key Responsibilities:

Clinical Development: Lead activities related to the Clinical Development Plan (CDP), Integrated Development Plan (IDP), product value proposition (TVP), target product profile (TPP), and market access strategy.
Medical Input: Provide medical support for clinical studies, including feasibility, medical review of data, documents, and communications to stakeholders. Ensure that medical queries from Health Authorities, Investigators, and study teams are addressed effectively.
Safety and Data Review: Conduct medical reviews of clinical trial data, including safety events and coding, and oversee centralized monitoring activities like data validation, protocol deviations, and key risk indicator (KRI) review.
Study Protocols: Lead the creation, amendments, and medical content of study protocols, including Informed Consent Documents (ICD). Ensure that all clinical documentation is in compliance with GCP, SOPs, and regulatory requirements.
Collaboration with Stakeholders: Collaborate with cross-functional teams, including Regulatory Affairs, Biostatisticians, Pharmacovigilance, Medical Affairs, and Clinical Operations, to ensure optimal study execution.
Regulatory Submissions: Contribute to the preparation and review of clinical documents such as Investigator Brochures, Clinical Study Reports, Lay Summaries, and Clinical Trial Authorization dossiers. Lead briefing packages for regulatory agencies.
Training and Presentations: Provide medical training, prepare presentations, and participate in Investigator meetings. Assist in managing adjudication and steering committees, if applicable.

About You

Experience:

Extensive clinical research experience, with a focus on clinical development and methodology.
Proven track record in managing clinical trials, ideally including Phase 3 trials.
Experience in writing scientific publications, presenting findings at conferences, and engaging with the scientific community.
Expertise in protocol development, clinical trial design, study endpoints, and ensuring adherence to regulatory and ethical standards.
Proficient in interpreting clinical trial data and making data-driven decisions related to safety and efficacy.

Soft Skills:

Strong leadership skills with the ability to collaborate across diverse internal and external stakeholders.
Excellent communication, presentation, and negotiation skills.
Ability to work within a matrix organization and manage multiple priorities.
Strong interpersonal skills and a strategic, performance-oriented mindset.
Ability to problem-solve and resolve conflicts effectively.
International and intercultural experience, with openness to new digital solutions in clinical research.

Technical Skills:

Expertise in pulmonary, allergy, immunology, or strong drug development experience.
In-depth knowledge of pre-clinical, translational, and clinical data, as well as the status of competitive products in relevant therapeutic areas.
Ability to critically analyze medical literature and assess its relevance to the clinical development program.
Strong negotiation skills and the ability to secure resources for clinical studies.

Education:

Medical Doctor (MD) or equivalent advanced degree in a relevant field.

Languages:

Fluent in English (both verbal and written).

Why Sanofi?

At Sanofi, we are committed to advancing progress in medicine through collaboration, innovation, and diversity. We provide equal opportunities for all employees, regardless of background. Join us and make a significant impact on patient care and medical knowledge.

Diversity and Inclusion:
We strive to create an inclusive environment, offering equal opportunities for everyone. Learn more about our Diversity, Equity, and Inclusion initiatives.

Apply now to be part of a transformative journey in clinical research!

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Clinical Research Lead

Job Description

About the Job

Main Responsibilities:

About You

Why Sanofi?

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