Remote Director of Patient Safety & Early Development

Boehringer Ingelheim; Ridgefield (CT); Remote; USD 265.000 - 397.000; Vollzeit

Zusammenfassung

Boehringer Ingelheim is seeking a Director, Patient Safety Physician 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 to align safety with benefit-risk decisions.

The position offers remote work in a global matrix environment, shaping safety strategy for first-in-human and

Qualifikationen

• MD or DO degree with ophthalmology residency, active/inactive license preferred.
• 5+ years total experience across clinical practice, research or industry, plus 2+ years in pharmaceutical safety or clinical development.
• Ability to synthesize diverse data into clear benefit-risk conclusions and recommendations.

Aufgaben

• 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 and other studies, including review of protocols, investigator brochures, safety monitoring plans and clinical study reports.
• Integrate clinical, nonclinical, translational, epidemiologic and external evidence to identify, communicate emerging safety risks and implications for development strategy.
• Partner with cross-functional development teams to define risk-management measures and contribute to governance, regulatory interactions and go/no-go decisions.
• Oversee ongoing safety surveillance, signal evaluation, aggregate safety assessment and input to regulatory documents (DSURs, RMPs, etc.).
• Represent Experimental Medicine Patient Safety in internal and external forums and lead matrix teams or strategic safety initiatives.

Kenntnisse

Executive leadership

Strategic thinking

Cross-functional collaboration

Medical judgment

Communication skills

Leadership presence

Ausbildung

US MD or DO degree

Ophthalmology residency

Jobbeschreibung

Boehringer Ingelheim is seeking a Director, Patient Safety Physician 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 to align safety with benefit-risk decisions.

The position offers remote work in a global matrix environment, shaping safety strategy for first-in-human and