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.