The incumbent provides enterprise-level strategic statistical leadership and oversight across all clinical programs and the broader Biostatistics function. They are responsible for driving cross-functional collaboration, managing CRO performance, and mentoring statistical staff to ensure high-quality deliverables.
The Executive Director of Statistical Programming provides strategic and operational leadership for statistical programming across clinical development programs. They oversee external vendors, establish programming standards, and partner with cross-functional teams to ensure high-quality regulatory submissions.
The Clinical Trial Manager will oversee the day-to-day operations of phase 1-3 clinical trials, including trial start-up, conduct, and close-out activities. They will serve as the primary contact for CROs and study service providers while ensuring compliance with ICH GCP regulations and internal SOPs.
The Senior Director of Clinical Quality Assurance provides strategic leadership and oversight for global clinical trials to ensure compliance with GCP and regulatory requirements. They are responsible for managing clinical quality systems, leading inspection readiness activities, and overseeing risk-based audits and CAPA processes.
The Director, Corporate Counsel will lead the drafting, review, and negotiation of a wide range of clinical and commercial agreements to support drug development and manufacturing. They will serve as a key legal advisor to internal stakeholders, providing strategic counsel on risk management, compliance, and intellectual property matters.
The role involves managing GxP compliance audits and the supplier quality management program to ensure adherence to company procedures and regulatory standards. The incumbent will coordinate audit schedules, facilitate audit deliverables, and oversee supplier qualification processes.
The Vice President of Clinical Development will provide strategic and operational leadership for global ophthalmic genetic medicine programs, serving as the primary medical monitor for clinical trials. They are responsible for overseeing clinical study design, regulatory document preparation, and cross-functional collaboration with internal and external partners.
The Executive Medical Director will lead the design, execution, and analysis of clinical trials in the ophthalmology therapeutic area, specifically for Phase 1 retina clinical trials. Responsibilities include ensuring subject safety, data integrity, and leading cross-functional study teams.
