Sr. Principal, Patient Safety & Experience

Role: Senior Principal, Patient Safety and Experience, responsible for evaluating safety signals from clinical trials and post-market data to ensure patient safety and regulatory compliance. Responsibilities: conduct medically-based reviews of adverse events; assess safety signals, perform risk assessments, and provide safety input for clinical trials, regulatory submissions, and product lifecycle management; support safety communications with authorities and stakeholders; ensure compliance with standards like FDA and EU MDR; and support risk management, safety documentation, and safety board presentations. Requirements: Bachelor’s degree or equivalent with 7+ years of relevant experience; ability to communicate fluently in English. Preferred: M.D. Ophthalmologist or O.D. with additional clinical safety expertise. High-Value: ophthalmic products, post-market surveillance, regulatory compliance, safety signal detection, hazard assessments, and cross-functional collaboration in a on-site role in Fort Worth, Texas, with up to 10% travel.