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Director, Patient Safety Physician – Ophthalmology
Boehringer Ingelheim. Lead proactive patient safety and benefit-risk strategy for assigned investigational compounds across early clinical development .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in patient safety and benefit-risk strategy for investigational compounds, with a strong foundation in clinical development and regulatory compliance. Capable of synthesizing complex data to inform safety assessments and lead cross-functional teams effectively.
Highest-signal resume keywords
US MD Or DO DegreeOphthalmology Residency TrainingPharmaceutical Safety ExperienceGlobal Pharmacovigilance KnowledgeLeadership And Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical DevelopmentSafety SurveillanceSignal ManagementAggregate ReportingRegulatory ComplianceMedical Safety LeadershipRisk ManagementData SynthesisEvidence-Based Decision MakingProtocol Review
Soft Skills
Strong LeadershipExecutive PresenceCommunication SkillsInitiativeAccountability
Certifications & Qualifications
Active Or Inactive Medical License
Industry Keywords
Investigational CompoundsClinical StudiesPatient SafetyBenefit-Risk StrategyCross-Functional TeamsRegulatory InteractionsExperimental MedicineSafety Monitoring PlansClinical Study ReportsEthical Mindset
About the role
Key responsibilities & impact- 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
- Review 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
- Partner with cross-functional development teams to define risk-management and risk-minimization measures
- Contribute to program governance, regulatory interactions and evidence-based go/no-go decisions
- Oversee ongoing safety surveillance, signal evaluation and aggregate safety assessment
- Provide 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
- Lead matrix teams or strategic safety initiatives as assigned
Requirements
What you’ll need- US MD or DO degree or international equivalent from an accredited institution
- Completion of ophthalmology residency training strongly preferred
- Completion of a US residency or ex-US equivalent strongly preferred
- Active or inactive medical license strongly preferred
- Active or inactive US license to practice medicine or international equivalent strongly preferred
- More than 5 years of total applicable experience, including clinical practice, research or relevant industry
- Minimum 2 years of experience in pharmaceutical safety, clinical development or a closely related field
- Sound medical-scientific judgment
- Ability to synthesize complex clinical, nonclinical and translational data into clear benefit-risk conclusions and recommendations
- Understanding of global pharmacovigilance and clinical-development safety requirements, including safety surveillance, signal management, aggregate reporting and regulatory compliance in major markets
- Strong leadership, executive presence and communication skills
- Experience influencing cross-functional teams in a global matrix environment
- People-leadership experience preferred
- Patient-first, highly ethical and accountable mindset
- Initiative to address ambiguity and take ownership
- Ability to attend key meetings in person as required
- Must be legally authorized to work in the United States without restriction
- Must be willing to take a drug test and post-offer physical, if required
- Must be 18 years of age or older
Benefits
Comp & perks- Competitive compensation and benefit programs
- Healthy working environment
- Meaningful work
- Mobility opportunities
- Networking opportunities
- Work-life balance
- Role-specific discretionary bonus eligibility
- Relocation eligibility
- Other compensation elements may be available