Sanofi · 14 hours ago
Development Scientifc Director, I&I
Morristown, NJ
Full-time
Onsite
Lead/Staff, Director/Executive
$178K/yr - $258K/yr
3+ years expSanofi is a company focused on advancing scientific breakthroughs in immunoscience and AI-powered research. The Development Scientific Director will lead development programs, providing clinical scientific expertise and ensuring the scientific relevance of clinical data for various studies and regulatory submissions.
Health CareLife SciencePharmaceuticalTherapeutics
Responsibilities
Provide expertise and act as a reference for all clinical scientific operational activities related to the projects/studies he/she is assigned to
Write/contribute/review/QC/validate study related documents: clinical protocols, written subject information, trial disclosure form, Case report form, study plans (eg: study risk management plan, central monitoring plan), study reports, material for training and meetings (such as investigators Meetings). Contribute to publications and communications of results
Collaborate and communicate appropriately with all stakeholders for optimal study execution, including but not limited to:
Provide input to the study extended synopsis and protocol based on feasibility pre-assessment, protocol complexity index and assist in determining associated cost
Responsible to support the overall supervision/execution of clinical scientific validation/review of study data, including writing or supervision of study related documents (eg: medical review plan, guidelines, etc…)
May organize/contribute to Investigators’ Meetings, Steering Committees, Data Monitoring Committees Meetings, adjudication committees and prepare related material (eg charter, presentations)
Provide clinical scientific answers to questions from Health Authorities, IRB/Ethics Committees, Investigators, experts, clinical study team
Secure Development Scientist trial master file documents readiness and availability, and mandatory trainings linked to the clinical function
Review/approve study-related documents (eg vendor specifications for centralized services, CRF, CRF completion guidance, patient diary, etc)
Interact with assigned Medical Writers to develop, review and finalize study protocols and reports
Maintain clinical scientific expertise in the therapeutic domain, including very good understanding of underlying disease biology and translation to development programs, and contributing to disease biomarker plans. Maintain very good understanding of disease pathophysiology, disease subtypes and clinical management
Collaborates with functions to ensure uniform, aligned operational approach (eg harmonizing study documents, ES, protocols, etc), as relevant, within a project, ensures leadership, builds consensus, coordinates action plans with other development colleagues and stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. He/she raises study or project-level issues to CSO and TA Heads, as relevant and shares relevant information within development and beyond (project teams, etc.)
Provide operational expertise to project clinical sub team, as needed
Supports the drafting of the extended synopsis of studies and subsequent protocol that he/she will be responsible for, and contribute to the clinical development plans (CDP), review of Investigator’s brochure, the clinical sections of integrated development plans (IDP), and overseeing the execution of such plans by the respective operational units in compliance with SOP, GCP and other regulations
Assisted by related Sanofi functions (e.g. clinical operations, project management, and procurement), responsible for defining timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials
Supports the team with defending the CDP in front of internal management committees, regulatory agencies, and alliance partners, where applicable. The Development Scientist may provide input into strategies to increase understanding of the mechanism of action of the drug including but not limited to the identification of biomarkers. On an ad hoc basis the Development Scientist will be requested to contribute expertise to specific tasks such as the evaluation of potential in-licensing candidates
Qualification
Required
Understanding of pharmaceutical product development and life cycle management gained through at least 2 years of development and clinical scientific experience
Very good scientific expertise
Very good expertise in clinical development and methodology of clinical studies
Very good communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
Demonstrated capability to challenge decision and status quo with a risk-management approach
Ability to negotiate to ensure operational resources are available for continued clinical conduct
Fluency in written and spoken English
Very good Teaching skills, demonstrated ability to assist and train others
Ability to work within a matrix model
Advanced degree such as PhD, in a Life Science or Health Science related field. MPH or Biomedical Science master combined with extensive drug development experience may be considered
At least 3 years previous experience in clinical development in pharmaceutical industry or a CRO or experience in clinical development in an Healthcare institution
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
Maryland Daily Record
2026-01-22
2026-01-22
2026-01-22
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