Development Scientific Director
Sanofi
7 hours ago
Remote friendly (Washington, DC)
United States
$178,500 - $257,833.33 USD yearly
Clinical Research and Development
Main Responsibilities
- Provide scientific contributions to support the Clinical Research Director (CRD) and/or clinical lead across study medical manager (SMM)–related activities, from trial setup and key study documents to clinical study reports and regulatory filing support (in compliance with quality and regulatory processes).
- Contribute to clinical development planning: input to clinical development plan; development of protocol and amendments; clinical trial materials; coordinate completion of CSRs.
- Serve as strategic lead for end-to-end study oversight (feasibility through close-out) to deliver high-quality data on time and within budget.
- Provide ophthalmology/gene therapy therapeutic expertise (retinal diseases, nAMD, geographic atrophy, etc.) including first-in-class compounds and novel modalities.
- Lead global Phase I–III ophthalmology clinical programs (gene therapy and novel modalities): drive feasibility, site selection, start-up, enrollment strategies, timelines; ensure milestones/enrollment goals; proactively identify/mitigate risks.
- Partner cross-functionally (Medical, Regulatory, Quality, Clinical Supply, Data Management, Biostatistics); collaborate with KOLs and sites; lead alignment meetings.
- Build, mentor, and manage clinical operations teams (CPMs, CTAs, CRAs); support hiring/onboarding; foster a high-performance culture.
- Oversee study start-up, enrollment, data quality, protocol compliance; safety signal monitoring with Medical Monitors; develop study documents (plans, ICFs, training, SOPs, CSRs); ensure GCP/regulatory/SOP compliance; drive process improvements.
- Collaborate on clinical systems (IRT, EDC, CTMS, ePRO) including UAT, training, and issue resolution.
Required Education & Experience
- Bachelor’s degree.
- 10+ years in pharmaceutical/biotech clinical development and/or clinical operations.
- Proven experience managing global Phase I–III trials from start-up through close-out.
Required Skills/Competencies
- Expert knowledge of ICH-GCP and FDA/global regulatory requirements.
- Risk management, protocol development, safety review.
- Budget development and financial management.
- Experience with in-sourced and fully outsourced (FSP/CRO) trial models.
- Clinical trial management systems/technologies.
- Lead/influence in matrix environments; vendor/cross-functional management; crisis management; strong communication.
Preferred Qualifications
- MS/PhD/PharmD.
- Experience with audit responses and regulatory inspections.
Travel
- Up to 20% travel.
- Provide scientific contributions to support the Clinical Research Director (CRD) and/or clinical lead across study medical manager (SMM)–related activities, from trial setup and key study documents to clinical study reports and regulatory filing support (in compliance with quality and regulatory processes).
- Contribute to clinical development planning: input to clinical development plan; development of protocol and amendments; clinical trial materials; coordinate completion of CSRs.
- Serve as strategic lead for end-to-end study oversight (feasibility through close-out) to deliver high-quality data on time and within budget.
- Provide ophthalmology/gene therapy therapeutic expertise (retinal diseases, nAMD, geographic atrophy, etc.) including first-in-class compounds and novel modalities.
- Lead global Phase I–III ophthalmology clinical programs (gene therapy and novel modalities): drive feasibility, site selection, start-up, enrollment strategies, timelines; ensure milestones/enrollment goals; proactively identify/mitigate risks.
- Partner cross-functionally (Medical, Regulatory, Quality, Clinical Supply, Data Management, Biostatistics); collaborate with KOLs and sites; lead alignment meetings.
- Build, mentor, and manage clinical operations teams (CPMs, CTAs, CRAs); support hiring/onboarding; foster a high-performance culture.
- Oversee study start-up, enrollment, data quality, protocol compliance; safety signal monitoring with Medical Monitors; develop study documents (plans, ICFs, training, SOPs, CSRs); ensure GCP/regulatory/SOP compliance; drive process improvements.
- Collaborate on clinical systems (IRT, EDC, CTMS, ePRO) including UAT, training, and issue resolution.
Required Education & Experience
- Bachelor’s degree.
- 10+ years in pharmaceutical/biotech clinical development and/or clinical operations.
- Proven experience managing global Phase I–III trials from start-up through close-out.
Required Skills/Competencies
- Expert knowledge of ICH-GCP and FDA/global regulatory requirements.
- Risk management, protocol development, safety review.
- Budget development and financial management.
- Experience with in-sourced and fully outsourced (FSP/CRO) trial models.
- Clinical trial management systems/technologies.
- Lead/influence in matrix environments; vendor/cross-functional management; crisis management; strong communication.
Preferred Qualifications
- MS/PhD/PharmD.
- Experience with audit responses and regulatory inspections.
Travel
- Up to 20% travel.