Development Scientific Director

Responsibilities:
- Provide scientific/medical contribution to CRD/clinical lead activities across complex global Phase I–III ophthalmology gene therapy programs.
- Contribute to key study documents/activities from clinical development plan and trial set-up through CSR, ensuring quality and regulatory compliance (ICH-GCP, FDA/global regs).
- Support clinical development plan input; develop/maintain trial protocol and amendments; develop study materials (study plans, ICFs, training materials, SOPs, CSRs) and coordinate CSR completion; support documents for regulatory filings.
- Lead end-to-end study oversight (feasibility through close-out) to deliver high-quality data on time and within budget.
- Drive program execution: feasibility, site selection, start-up, enrollment strategies, timelines; ensure enrollment goals/milestones; proactively identify/mitigate risks.
- Collaborate cross-functionally (Medical, Regulatory, Quality, Clinical Supply, Data Management, Biostatistics) and with KOLs/investigative sites/CROs/vendors; lead alignment meetings.
- Build/mentor/manage clinical operations teams (Clinical Project Managers, CTAs, CRAs) and support hiring/onboarding.
- Oversee study start-up (site activation, regulatory submissions, training), monitor enrollment/data quality/protocol compliance, and coordinate safety signal monitoring.
- Implement/optimize clinical systems (IRT, EDC, CTMS, ePRO), oversee UAT/training, and resolve issues.

Qualifications:
- Required: Bachelor’s degree; 10+ years pharma/biotech clinical development and/or clinical operations; track record managing global Phase I–III trials start-up through close-out.
- Technical: ICH-GCP and FDA/global regulatory expertise; risk management, protocol development, safety review; budget/financial management; experience with in-sourced and fully outsourced (FSP/CRO) models; proficiency with clinical trial management systems.
- Leadership: lead/influence in matrix environments; vendor and cross-functional management; crisis/problem-solving; strategic balance of near-/long-term goals; strong communication/stakeholder management.
- Preferred: MS/PhD/PharmD; audit responses/regulatory inspection experience.
- Therapeutic: ophthalmology clinical trial experience incl. gene therapy (e.g., retinal diseases, nAMD, geographic atrophy); first-in-class compounds and novel modalities.

Benefits (explicit): high-quality healthcare, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.

Travel: up to 20%.