Sanofi · 4 hours ago
Clinical Research Director (CRD), Rare Diseases
Morristown, NJ
Full-time
Onsite
Lead/Staff, Director/Executive
$206K/yr - $298K/yr
2+ years expSanofi is an R&D-driven, AI-powered biopharma company committed to improving people’s lives. The Clinical Research Director (CRD) for Rare Diseases is responsible for the creation and execution of clinical development strategies for assigned projects, advancing scientific knowledge, and leading clinical study development in collaboration with clinical operations.
Health CareLife SciencePharmaceuticalTherapeutics
Responsibilities
Create clinical development strategy and plans for one or more assets
Lead and coordinate cross-functional teams to design, implement, and execute clinical development plans and studies
Align clinical development strategy with the global project team and internal partners, such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing
Advance the clinical development plan through internal management review
Lead a clinical sub team to design clinical studies and to create study protocols
Execute the clinical development plan in close collaboration with clinical operations
Advance scientific and clinical knowledge in rare diseases
Incorporate new trial, scientific and digital methodologies
Pro-actively progress study execution
Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations
Review documents supporting clinical development such as Investigator’s brochure, regulatory documents for IND / CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval
Engage with health authorities (contribute to health authority submissions (such as new drug application) and timely response to regulatory reviews)
Serve as a medical expert and provide strategic input to early-stage programs
Collaborate with external experts, key opinion leaders, and investigators to advance clinical research
Represent Sanofi at scientific conferences and regulatory meetings
Designs the global clinical development strategy (in close cooperation with other members of the team, particularly Regulatory Affairs end Health Economics) and leads the clinical development with regard to ongoing development activities and planned LCM for labelling changes
Assessment of the Clinical benefit –risk profile during development and LCM on an ongoing basis, in strong collaboration with GPE and the CSO team
Provides clinical input to the Target Product Profile
Adjusts and updates the clinical strategy when necessary according to the project progression and information available
Contributes to the life cycle management strategy for the project whenever appropriate
Generates the Clinical Development Plan
Prepares the clinical part of meeting requests and briefing packages for meetings with Regulatory agencies
Generates the extended synopsis for clinical trials and reviews the protocols and protocol amendments prepared by the Clinical Study Director (CSD)
Writes or updates the clinical section of the Clinical Investigator Brochure and the clinical parts of the Clinical Trial Authorization dossier (IMPD, IND) in collaboration with the pharmacovigilance (GPE) department and the clinical pharmacologist
Reviews and when appropriate approves the committees charters
Prepares with the support of the medical writing department the summary of clinical efficacy and clinical overview of the Common Technical Document (CTD). Provide input and reviews all clinical sections of the CTD (clinical pharmacology, summary of clinical safety…) and other sections whenever appropriate
Prepares answers to questions from Regulatory Agencies on the clinical efficacy of the project and collaborates with GPE in preparing answers on the clinical safety of the project, collaborates on other sections whenever appropriate
In charge of the medical/clinical assessment of license-in opportunities
Qualification
Required
MD or MD/PhD in a relevant scientific discipline, preferably pulmonology, with at least 2 years relevant experience in clinical development within the pharmaceutical industry, academia, or government agencies such as the NIH, FDA, or other equivalent national or international public health and regulatory organization
Experience/enthusiasm in advancing assets from discovery into clinical development (experience in pharma or academia)
Have experience in novel approaches to translational medicine
Demonstrate problem solving skills
Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area
Strong leadership skills with the ability to influence and collaborate effectively in a matrix environment
Excellent communication and presentation skills, with the ability to articulate complex scientific concepts to diverse audiences
Proven track record of scientific publications and presentations at international conferences
Benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Company
Sanofi
Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.
10001+ employees
H1B Sponsorship
Sanofi has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (68)
2023 (59)
2022 (78)
2021 (38)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$6.97BKey Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.74B
2025-03-05Post Ipo Debt· $1.59B
Leadership Team
Paul Hudson
Chief Executive Officer
Francois-Xavier Roger
Chief Financial Officer
Recent News
2026-01-25
BioWorld Financial Watch
2026-01-25
2026-01-24
Company data provided by crunchbase