Director, Patient Safety Physician – Cardio Renal Metabolic

🕒 Setembro 24

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💵 $265.000 - $397.400 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

🦅 Patrocina Visto H1B

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Boehringer Ingelheim

10.000+ funcionários

🏥 Saúde

🏭 Manufatura

💊 Farmacêutico

Healthcare • Manufacturing • Pharmaceuticals

A Boehringer Ingelheim é uma empresa farmacêutica global, de propriedade familiar, guiada por pesquisa e com sede na Alemanha, que descobre, desenvolve, fabrica e comercializa medicamentos prescritos, biofarmacêuticos, vacinas e produtos de saúde animal. A empresa se concentra em áreas terapêuticas, incluindo doenças respiratórias, cardiovasculares, metabólicas, oncologia, imunologia e doenças zoonóticas, e investe fortemente em P&D e biotecnologia para avançar na descoberta e desenvolvimento de medicamentos. Opera em todo o mundo nos mercados de produtos farmacêuticos humanos e saúde animal, estabelecendo parcerias com instituições acadêmicas e empresas de biotecnologia para transformar pesquisas científicas em terapias.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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

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