The Vice President of Clinical Operations provides strategic leadership and oversight for complex global clinical programs, ensuring trials are executed with excellence, on time, and within budget. This role manages cross-functional teams and external vendors while fostering a culture of operational excellence and continuous improvement.
The Associate Director provides strategic statistical expertise and methodology to lead assigned clinical projects and cross-functional teams. They are responsible for developing statistical analysis plans, randomization schemas, and ensuring the quality and accuracy of data analysis and reporting.
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 Clinical Trial Manager is responsible for the day-to-day operations of Phase 1-3 clinical trials, including start-up, conduct, and close-out activities. This includes overseeing CROs, managing study budgets, and ensuring compliance with ICH GCP and regulatory requirements.
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.
Responsible for the implementation, execution, and oversight of clinical trials within a program to ensure they are on time, within budget, and GCP compliant. This includes managing clinical vendors, mentoring junior staff, and collaborating with cross-functional teams to maintain inspection readiness.
