Development Scientific Director
Sanofi
5 hours ago
Remote friendly (Cambridge, MA)
United States
$178,500 - $257,833.33 USD yearly
Clinical Research and Development
Main Responsibilities
- Provide scientific/medical contribution to global ophthalmology and gene therapy clinical trials; support CRD/clinical lead on Study Medical Manager (SMM)–related activities (key study documents/activities from development plan and trial set-up through clinical study report) in line with quality and regulatory processes.
- Contribute to clinical development plan input; develop/maintain clinical trial protocol and amendments and clinical trial materials.
- Coordinate completion of clinical study reports and support preparation of documents for regulatory filings.
- Serve as strategic lead for end-to-end study oversight (feasibility through close-out), ensuring high-quality data on time and within budget.
- Lead global Phase I–III strategy/execution for ophthalmology programs (gene therapy and novel modalities); drive feasibility, site selection, start-up, enrollment strategy, timelines; ensure enrollment goals/milestones; identify/mitigate risks.
- Collaborate with cross-functional teams (Medical, Regulatory, Quality, Clinical Supply, Data Management, Biostatistics) and external stakeholders (CROs, vendors, sites, KOLs) to develop protocols, training, and operational strategies; lead cross-functional meetings.
- Build/mentor/manage clinical operations teams (Clinical Project Managers, CTAs, CRAs); guide professional development; participate in hiring/onboarding.
- Oversee study start-up (site activation, regulatory submissions, training); monitor enrollment/data quality/protocol compliance; manage safety monitoring with Medical Monitors.
- Lead development of study documents (plans, ICFs, training materials, SOPs, CSRs) and ensure GCP/regulatory/SOP compliance; drive process improvements.
- Implement/optimize clinical systems (IRT, EDC, CTMS, ePRO) including UAT, training, and issue resolution.
Required
- Bachelor’s degree.
- 10+ years in pharmaceutical/biotech clinical development and/or clinical operations.
- Track record managing global Phase I–III trials start-up through close-out.
- Ophthalmology clinical trial experience including gene therapy (e.g., retinal diseases, nAMD, geographic atrophy).
- Expert knowledge of ICH-GCP, FDA regulations, and global regulatory requirements; risk management, protocol development, safety review.
- Budget development and financial management; experience with in-sourced and fully outsourced (FSP/CRO) models.
Preferred
- MS/PhD/PharmD.
- Experience with audit responses and regulatory inspections.
Skills/Competencies
- Lead/influence in matrix environments; vendor and cross-functional management/accountability.
- Crisis management/problem-solving; strategic thinking; communication and stakeholder management.
Travel
- Up to 20%.
Benefits
- Health and wellbeing benefits; high-quality healthcare; prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.
- Provide scientific/medical contribution to global ophthalmology and gene therapy clinical trials; support CRD/clinical lead on Study Medical Manager (SMM)–related activities (key study documents/activities from development plan and trial set-up through clinical study report) in line with quality and regulatory processes.
- Contribute to clinical development plan input; develop/maintain clinical trial protocol and amendments and clinical trial materials.
- Coordinate completion of clinical study reports and support preparation of documents for regulatory filings.
- Serve as strategic lead for end-to-end study oversight (feasibility through close-out), ensuring high-quality data on time and within budget.
- Lead global Phase I–III strategy/execution for ophthalmology programs (gene therapy and novel modalities); drive feasibility, site selection, start-up, enrollment strategy, timelines; ensure enrollment goals/milestones; identify/mitigate risks.
- Collaborate with cross-functional teams (Medical, Regulatory, Quality, Clinical Supply, Data Management, Biostatistics) and external stakeholders (CROs, vendors, sites, KOLs) to develop protocols, training, and operational strategies; lead cross-functional meetings.
- Build/mentor/manage clinical operations teams (Clinical Project Managers, CTAs, CRAs); guide professional development; participate in hiring/onboarding.
- Oversee study start-up (site activation, regulatory submissions, training); monitor enrollment/data quality/protocol compliance; manage safety monitoring with Medical Monitors.
- Lead development of study documents (plans, ICFs, training materials, SOPs, CSRs) and ensure GCP/regulatory/SOP compliance; drive process improvements.
- Implement/optimize clinical systems (IRT, EDC, CTMS, ePRO) including UAT, training, and issue resolution.
Required
- Bachelor’s degree.
- 10+ years in pharmaceutical/biotech clinical development and/or clinical operations.
- Track record managing global Phase I–III trials start-up through close-out.
- Ophthalmology clinical trial experience including gene therapy (e.g., retinal diseases, nAMD, geographic atrophy).
- Expert knowledge of ICH-GCP, FDA regulations, and global regulatory requirements; risk management, protocol development, safety review.
- Budget development and financial management; experience with in-sourced and fully outsourced (FSP/CRO) models.
Preferred
- MS/PhD/PharmD.
- Experience with audit responses and regulatory inspections.
Skills/Competencies
- Lead/influence in matrix environments; vendor and cross-functional management/accountability.
- Crisis management/problem-solving; strategic thinking; communication and stakeholder management.
Travel
- Up to 20%.
Benefits
- Health and wellbeing benefits; high-quality healthcare; prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.