Director, Patient Safety Physician – Cardio Renal Metabolic

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $265k - $397.4k / year

⏰ Full Time

🔴 Lead

👔 Director

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Boehringer Ingelheim

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🏭 Manufacturing

💊 Pharmaceuticals

Healthcare • Manufacturing • Pharmaceuticals

Boehringer Ingelheim is a global, research-driven, family-owned pharmaceutical company headquartered in Germany that discovers, develops, manufactures, and markets prescription medicines, biopharmaceuticals, vaccines, and animal health products. The company focuses on therapeutic areas including respiratory, cardiovascular, metabolic, oncology, immunology, and zoonotic diseases, and invests heavily in R&D and biotechnology to advance drug discovery and development. It operates worldwide across both human pharmaceuticals and animal health markets, partnering with academic institutions and biotech firms to translate scientific research into therapies.

📋 Description

• 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 • 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

• US MD or DO degree or international equivalent from an accredited institution • Completion of ophthalmology residency training is strongly preferred • Active or inactive medical license is strongly preferred • More than 5 years of total applicable experience, including clinical practice, research or pharmaceutical industry • Minimum of 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 is preferred • Patient-first, highly ethical and accountable mindset • Initiative to address ambiguity and take ownership • Willingness 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

• Role-specific discretionary bonus eligibility • Relocation assistance may be available • Other compensation elements may be available • Health and wellbeing support • Meaningful work and work-life balance support • Mobility and networking opportunities • Competitive compensation and benefit programs • International collaboration opportunities