Ophthalmology Patient Safety Director | Strategic Leader

Boehringer Ingelheim GmbH; Maryland; Hybrid; USD 265,000 - 397,000; Full time

Job summary

Boehringer Ingelheim is seeking a Director, Patient Safety Physician - Ophthalmology to provide strategic medical safety leadership for investigational compounds across early clinical development. The role collaborates with Clinical Development, Translational Medicine, Regulatory Affairs, Biostatistics, Epidemiology and Global Pharmacovigilance in a remote, global matrix environment.

The position leads safety strategy for first‑in‑human, dose‑escalation and proof‑of‑concept studies, reviews

Qualifications

• MD or DO degree or international equivalent.
• Completion of ophthalmology residency training.
• Active or inactive medical license is strongly preferred.
• Completion of a US residency or ex-US equivalent.

Responsibilities

• Lead proactive patient safety and benefit-risk strategy for assigned investigational compounds across early clinical development.
• Provide medical safety leadership for first-in-human, dose-escalation, proof-of-concept and other clinical studies, including review of protocols, investigator brochures, safety monitoring plans and clinical study reports.
• Integrate clinical, nonclinical, translational, epidemiologic and external evidence to identify, characterize and communicate emerging safety risks and their implications for development strategy.
• Partner with cross-functional development teams to define risk-management and risk-minimization measures and contribute to program governance, regulatory interactions and evidence-based go/no-go decisions.
• Oversee ongoing safety surveillance, signal evaluation, aggregate safety assessment and input to regulatory documents (DSURs, RMPs, submission safety sections).
• Represent Patient Safety in internal and external forums, communicate evolving safety profile to senior leaders and regulators, and lead matrix teams or strategic safety initiatives.

Education

MD or DO degree

Ophthalmology residency

Medical license

US residency or ex-US equivalent

Job description

Boehringer Ingelheim is seeking a Director, Patient Safety Physician - Ophthalmology to provide strategic medical safety leadership for investigational compounds across early clinical development. The role collaborates with Clinical Development, Translational Medicine, Regulatory Affairs, Biostatistics, Epidemiology and Global Pharmacovigilance in a remote, global matrix environment.

The position leads safety strategy for first‑in‑human, dose‑escalation and proof‑of‑concept studies, reviews