Director, Patient Safety Physician - Ophthalmology

Accountabilities:: Lead proactive patient safety and benefit-risk strategies for assigned investigational compounds throughout early clinical development. Provide medical safety leadership for first-in-human, dose-escalation, proof-of-concept, and other clinical studies. Review protocols, investigator brochures, safety monitoring plans, clinical study reports, and other key development documents from a medical safety perspective. Integrate clinical, nonclinical, translational, epidemiologic, and external evidence to identify, characterize, and communicate emerging safety risks. Translate safety findings into clear recommendations regarding development strategy, risk management, and risk minimization. Partner with cross-functional development teams to support program governance, regulatory interactions, and evidence-based go/no-go decisions. Oversee ongoing safety surveillance, signal evaluation, and aggregate safety assessments. Provide medically sound input into regulatory documents, including Development Safety Update Reports (DSURs), Risk Management Plans (RMPs), and safety sections of regulatory submissions. Represent Experimental Medicine Patient Safety in internal and external forums and communicate evolving safety profiles to senior leadership and regulatory stakeholders. Lead matrix teams and strategic safety initiatives as assigned, fostering effective collaboration across global functions. Requirements: MD or DO degree from an accredited institution, or an international equivalent. Completion of ophthalmology residency training is strongly preferred, along with an active or inactive medical license. Completion of a U.S. residency or equivalent international training is strongly preferred. At least 5 years of total applicable experience across clinical practice, research, industry, or related areas. Minimum of 2 years of experience in pharmaceutical safety, clinical development, or a closely related field. Strong medical and scientific judgment, with the ability to synthesize complex clinical, nonclinical, and translational evidence into clear benefit-risk conclusions and recommendations. Strong understanding of global pharmacovigilance and clinical development safety requirements, including safety surveillance, signal management, aggregate reporting, and regulatory compliance across major markets. Strong leadership, executive presence, communication, and influencing skills, with experience working across cross-functional teams in a global matrix environment. People leadership experience is preferred. Patient-first, ethical, and accountable approach, with the initiative and adaptability to navigate ambiguity and take ownership of complex safety decisions. Willingness to attend key meetings in person when required. Must be legally authorized to work in the United States without restriction. Must be at least 18 years old and willing to complete a drug test and post-offer physical examination if required. Benefits: Base salary range of $265,000–$397,400. Eligibility for a role-specific discretionary bonus. Potential relocation assistance. Additional compensation opportunities may apply. Competitive benefits and rewards package. Opportunities to collaborate with international teams and contribute to global clinical development programs. Remote work within the United States. A collaborative global matrix environment supporting professional development, meaningful work, mobility, networking, and work-life balance.