Director, Patient Safety Physician - Ophthalmology

Join Global Experimental Medicine Patient Safety as a Director and provide strategic medical safety leadership for investigational compounds across early clinical development. The role partners closely with Clinical Development, Translational Medicine, Regulatory Affairs, Biostatistics, Epidemiology and Global Pharmacovigilance to translate emerging evidence into clear benefit-risk decisions for patients and programs.

This position offers the opportunity to shape safety strategy for first-in-human, proof-of-concept and other development studies, influence cross-functional governance and guide programs through complex medical and scientific decisions.

The position is remote and works in a highly collaborative global matrix environment.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance.

Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

• 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 medically sound input to regulatory documents, including DSURs, RMPs and submission safety sections.
• Represent Experimental Medicine Patient Safety in internal and external forums, communicate the evolving safety profile to senior leaders and regulators, and lead matrix teams or strategic safety initiatives as assigned.

• US MD or DO degree or international equivalent from an accredited institution; completion of ophthalmology residency training and an active or inactive medical license are strongly preferred.
• In addition, the following are strongly preferred:
  • Completion of a US residency or ex-US equivalent.
  • Active or inactive US license to practice medicine or international equivalent.
• Total applicable experience (incl. clinical practice, research or relevant industry) of greater than five (5) years, and a minimum of two (2) years of experience in pharmaceutical safety, clinical development or a closely related field.
• Demonstrate sound medical-scientific judgment and the ability to synthesize complex clinical, nonclinical and translational data into clear benefit-risk conclusions and recommendations.
• Understand global pharmacovigilance and clinical-development safety requirements, including safety surveillance, signal management, aggregate reporting and regulatory compliance in major markets.
• Show strong leadership, executive presence and communication skills, with experience…