Clinical Research Job at Sanofi USA
Are you searching for a prestigious Clinical Research Job in the global pharmaceutical industry? Here is an exciting leadership opportunity from Sanofi Careers for experienced medical professionals passionate about immunology, respiratory medicine, and clinical development. This opening for a Clinical Research Director offers exceptional exposure to AI-powered drug development, global clinical trials, and regulatory strategy. If you are exploring advanced MD Jobs in clinical research and pharmaceutical innovation, this role could become a major milestone in your professional journey.
About Sanofi Careers
Sanofi Careers represents opportunities at Sanofi, a globally recognized R&D-driven biopharmaceutical company committed to improving human health through innovative medicines and vaccines. With strong expertise in immunology, rare diseases, vaccines, and specialty care, Sanofi combines cutting-edge science with AI-powered research to accelerate medical breakthroughs. The company operates globally and provides excellent career pathways for professionals seeking leadership roles in pharmaceutical research, clinical development, and advanced MD Jobs.
Job Details:
- Job Title: Clinical Research Director, I&I
- Locations: Cambridge, MA / Morristown, NJ
- Job Type: Full-time
- Application Deadline: September 18, 2026
- Job Requisition ID: R2847396
About the Job
The Clinical Research Director (CRD) role is part of an R&D-driven, AI-powered biopharma environment focused on advancing immunoscience and clinical innovation.
The CRD serves as the medical expert in the development of R&D programs and is expected to contribute strategically and operationally across multiple clinical development activities.
The role requires:
- Strong organizational and analytical skills
- Strategic and operational focus
- Emotional intelligence and self-motivation
- Ability to manage multiple responsibilities effectively
Project Overview
The project focuses on:
- Lunsekimig
A novel bi-specific nanobody targeting both:
- TSLP
- IL-13
Lunsekimig is currently being developed across multiple immunology disease areas.
The organization is seeking a clinician-scientist to lead clinical trials within the respiratory research space.
Main Responsibilities
The Clinical Research Director will:
- Provide medical expertise within study teams across early and late clinical development phases
- Collaborate with:
- Development Medical Directors (DMDs)
- Development Scientific Directors (DSDs)
- Global Safety Officers
- Regulatory Strategists
- Global Project Teams
- Develop regulatory study documentation including:
- Abbreviated protocols
- Study protocols
- Protocol amendments
- Lead study start-up activities such as:
- Pressure testing
- Competitive intelligence
- Patient engagement
- Cluster feasibility
- Study risk assessment
- Provide medical support for:
- IRB responses
- Health authority questions
- Medical training
- Centralized monitoring reviews
- Contribute to:
- Common Technical Documents (CTD)
- Regulatory submissions to FDA, EMA, PMDA, and other agencies
- Serve as the medical reference within clinical study teams
- Ensure medical relevance and quality of clinical data
Key Responsibilities
Clinical Development Leadership
The CRD will:
- Lead clinical development plan strategies
- Oversee clinical sections of integrated development plans (IDP)
- Coordinate action plans with stakeholders
- Identify and manage project risks and corrective actions
- Contribute to:
- Target Value Proposition (TVP)
- Target Product Profile (TPP)
- Market access strategies
- Collaborate with:
- External partners
- Regulatory agencies
- Scientific experts
- Internal stakeholders
Clinical Trial Execution
Responsibilities include:
- Supporting project clinical sub-teams
- Reviewing medical literature and competitive product data
- Overseeing execution of clinical studies
- Collaborating with:
- Clinical operations
- Patient Safety and Pharmacovigilance
- Regulatory teams
- Finance
- Procurement
- Project management
- Ensuring compliance with:
- Good Clinical Practice (GCP)
- Applicable laws and regulations
- Standard Operating Procedures (SOPs)
- Managing:
- Timelines
- Budgets
- Risk mitigation plans
Protocol & Documentation Management
The role includes:
- Developing abbreviated and final protocols
- Reviewing protocol amendments
- Developing/reviewing:
- Core Study Informed Consent Forms (CSICF)
- Study committee charters
- Study plans
- Risk management plans
- Monitoring plans
- Providing clinical input for:
- Vendor RFPs
- e-CRFs
- eCOA systems
- Participating in:
- Investigator meetings
- Team training activities
Data Review & Safety Oversight
The CRD will:
- Ensure clinical data quality through ongoing validation and blinded review
- Conduct:
- Adverse event reviews
- Clinical case reviews
- Statistical surveillance for efficacy data
- Maintain trial master file readiness
- Lead study-specific committees such as:
- IDMC
- Steering committees
- Adjudication committees
- Collaborate on Statistical Analysis Plans (SAP) with biostatistics teams
- Develop/review Clinical Study Reports (CSR)
Regulatory & Safety Responsibilities
Responsibilities include:
- Reviewing clinical sections of:
- Investigator’s Brochure
- CTA
- IND
- DSUR
- DRMP
- RMP
- Writing/reviewing:
- BLA/CTD sections
- Regulatory briefing packages
- PSP/PIP documents
- Participating in:
- Regulatory meetings
- Advisory committee preparations
- Collaborating with Patient Safety teams for:
- Safety signal detection
- Safety documentation
Scientific Contributions
The Clinical Research Director will:
- Participate in and author:
- Manuscripts
- Scientific abstracts
- Maintain collaborations with:
- Knowledge experts
- Advisory boards
- Support evaluation of:
- Potential in-licensing candidates
- Research initiatives within therapeutic areas
Candidate Requirements
Experience
Candidates should possess:
- Minimum 3 years of experience in:
- Clinical development within pharmaceutical companies
- CRO environments
- Clinical development in healthcare institutions
Preferred Background
- Respiratory
- Allergy
- Immunology
Soft Skills
The ideal candidate should demonstrate:
- Strong verbal and written communication skills
- Excellent problem-solving abilities
- Ability to challenge decisions using a risk-management approach
- Negotiation and resource management skills
- Teaching and mentoring capabilities
- Ability to work in matrix organizations
- International and intercultural collaboration skills
- Openness to digital and AI-enabled solutions
Technical Skills
Candidates should possess:
- Understanding of pharmaceutical product development and lifecycle management
- Strong scientific and clinical expertise
- Advanced knowledge of clinical development methodologies
Education
- MD (Doctor of Medicine) or equivalent patient-care related medical degree required
- DO or international equivalent accepted
Language Requirement
- Fluent English (spoken and written)
Why Choose Sanofi?
Sanofi offers:
- Opportunities to contribute to transformative scientific innovation
- Global career growth and mobility opportunities
- Competitive rewards and recognition programs
- Comprehensive health and wellbeing benefits
- Prevention and wellness programs
- Minimum 14 weeks of gender-neutral parental leave
- A collaborative and future-focused work environment
