Job Description

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. This senior medical safety leadership role focuses on protecting patients and guiding benefit-risk decisions for investigational compounds during early clinical development. You’ll shape safety strategy across first-in-human, dose-escalation, proof-of-concept, and other development studies. The role brings together clinical, nonclinical, translational, epidemiologic, and external evidence to identify emerging risks and inform development decisions. You’ll work closely with Clinical Development, Translational Medicine, Regulatory Affairs, Biostatistics, Epidemiology, and Global Pharmacovigilance teams. The position offers significant influence over cross-functional governance, regulatory strategy, and evidence-based program decisions. Working remotely in a global matrix environment, you’ll also communicate evolving safety profiles to senior leaders and regulatory stakeholders. 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.

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