Sanofi
Development Scientific Director, Ophthalmology
Sanofi, Convent Station, New Jersey, us, 07961
Development Scientific Director, Ophthalmology
Base Pay Range:
$172,500.00/yr - $287,500.00/yr
Job Title:
Development Scientific Director Location:
Morristown, NJ, Cambridge, MA
About the Job:
Join the engine of Sanofi’s mission—where deep immunoscience meets bold, AI‑powered research. In R&D you’ll drive breakthroughs that could turn the impossible into possible for millions. The Development Scientific Director is a key member of the clinical team dedicated to the development and execution of clinical strategies and the clinical and operational implementation of a complex compound program.
Main Responsibilities
Provide active scientific contribution to a cross‑functional clinical team developing a molecular entity, including input to the clinical development plan, development of the clinical trial protocol, clinical trial materials and coordination of clinical study reports.
Lead or represent clinical development across specific aspects of clinical trial execution, collaborating with Coding specialists, Biostatisticians, Data Managers, Study Managers, Feasibility Managers, Pharmacovigilance, and Medical Writers on high‑quality medical scientific documents.
Evaluate scientific opportunities in the therapeutic area and contribute to the review and consistency of safety data with the Clinical Trial Team and Pharmacovigilance.
Prepare supporting documents for regulatory filings, such as CSRs, IBs/INDs, and briefing books.
Qualifications
Ophthalmology/retina clinical development and clinical trial methodology knowledge and experience.
Leadership skills to direct and organize activities on behalf of the Clinical Research Director.
Scientific expertise or strong interest and ability to learn in the domain of the assigned study/project.
Experience drafting protocols, amendments, and regulatory documents.
Familiarity with digital tools such as data analytics.
Quality focus, critical data‑driven and risk management approach.
Ability to work autonomously, provide status reports and anticipate and elevate issues.
Well organized, high level of autonomy, motivation and strong communication skills (verbal and written).
Multiple task handling, prioritization, and proposal development for challenging situations.
Experience working internationally and strong English skills (verbal and written).
May require up to 15% travel.
Formal Education and Experience
Ph.D. preferred; Master’s degree considered for candidates with extensive experience.
Minimum of 3 years of phase I‑III clinical trial/drug development experience within the ophthalmology/retina pharmaceutical industry or CRO.
Knowledge in ICH, GCP and fluency in English.
Knowledge and Skills Desirable (Not Essential)
Global trial experience.
Clinical operations experience.
Statistical, data management experience.
Regulatory knowledge.
Why Choose Us
Supportive, future‑focused team delivering miracles of science.
Endless growth opportunities, promotion or lateral moves at home or internationally.
Thoughtful rewards package that recognizes contribution and amplifies impact.
Comprehensive health and wellbeing benefits, including at least 14 weeks gender‑neutral parental leave.
Equal Opportunity Employer
– Sanofi Inc. and its U.S. affiliates are committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status; sex, gender, gender identity or expression, sexual orientation, disability, veteran or military status, domestic violence victim status, genetic information, or any other characteristic protected by law.
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$172,500.00/yr - $287,500.00/yr
Job Title:
Development Scientific Director Location:
Morristown, NJ, Cambridge, MA
About the Job:
Join the engine of Sanofi’s mission—where deep immunoscience meets bold, AI‑powered research. In R&D you’ll drive breakthroughs that could turn the impossible into possible for millions. The Development Scientific Director is a key member of the clinical team dedicated to the development and execution of clinical strategies and the clinical and operational implementation of a complex compound program.
Main Responsibilities
Provide active scientific contribution to a cross‑functional clinical team developing a molecular entity, including input to the clinical development plan, development of the clinical trial protocol, clinical trial materials and coordination of clinical study reports.
Lead or represent clinical development across specific aspects of clinical trial execution, collaborating with Coding specialists, Biostatisticians, Data Managers, Study Managers, Feasibility Managers, Pharmacovigilance, and Medical Writers on high‑quality medical scientific documents.
Evaluate scientific opportunities in the therapeutic area and contribute to the review and consistency of safety data with the Clinical Trial Team and Pharmacovigilance.
Prepare supporting documents for regulatory filings, such as CSRs, IBs/INDs, and briefing books.
Qualifications
Ophthalmology/retina clinical development and clinical trial methodology knowledge and experience.
Leadership skills to direct and organize activities on behalf of the Clinical Research Director.
Scientific expertise or strong interest and ability to learn in the domain of the assigned study/project.
Experience drafting protocols, amendments, and regulatory documents.
Familiarity with digital tools such as data analytics.
Quality focus, critical data‑driven and risk management approach.
Ability to work autonomously, provide status reports and anticipate and elevate issues.
Well organized, high level of autonomy, motivation and strong communication skills (verbal and written).
Multiple task handling, prioritization, and proposal development for challenging situations.
Experience working internationally and strong English skills (verbal and written).
May require up to 15% travel.
Formal Education and Experience
Ph.D. preferred; Master’s degree considered for candidates with extensive experience.
Minimum of 3 years of phase I‑III clinical trial/drug development experience within the ophthalmology/retina pharmaceutical industry or CRO.
Knowledge in ICH, GCP and fluency in English.
Knowledge and Skills Desirable (Not Essential)
Global trial experience.
Clinical operations experience.
Statistical, data management experience.
Regulatory knowledge.
Why Choose Us
Supportive, future‑focused team delivering miracles of science.
Endless growth opportunities, promotion or lateral moves at home or internationally.
Thoughtful rewards package that recognizes contribution and amplifies impact.
Comprehensive health and wellbeing benefits, including at least 14 weeks gender‑neutral parental leave.
Equal Opportunity Employer
– Sanofi Inc. and its U.S. affiliates are committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status; sex, gender, gender identity or expression, sexual orientation, disability, veteran or military status, domestic violence victim status, genetic information, or any other characteristic protected by law.
#J-18808-Ljbffr