This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Patient Safety Physician - Ophthalmology based in the United States.
Responsibilities
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
Conditions
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