Director, Local Study Operations Manager

🕒 Novembro 2

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $195.876 - $265.008 / ano

⏰ Tempo Integral

🔴 Especialista

⚙️ Operações

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Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Healthcare • Biotechnology • Pharmaceuticals

A Amgen está comprometida a liberar o potencial da biologia para pacientes que sofrem de doenças graves, descobrindo, desenvolvendo, fabricando e fornecendo terapias humanas inovadoras. Esta abordagem começa utilizando ferramentas como genética humana avançada para desvendar as complexidades das doenças e entender os fundamentos da biologia humana.

Descrição

• Provide strategic and operational leadership for the country LSOM organization • Oversee quality, timeliness, cost, and compliant execution of the country clinical study portfolio • Translate global clinical development strategy into country operating priorities • Direct portfolio delivery, resource and capacity strategy, financial planning, quality and risk management, vendor performance, and inspection readiness from feasibility through study close-out • Influence study placement and portfolio decisions • Lead resolution of significant operational issues • Develop organizational capability and succession plans • Represent LSOM operations in country, regional, and global governance forums • Lead delivery of the country study portfolio through the LSOM management organization • Establish portfolio-level oversight of delivery, quality, risk, timelines, and performance • Manage LSOM and vendor performance and serve as the primary escalation point for local study challenges • Build leadership capability through coaching, development, and succession planning • Partner with CRA, CSPO, Quality, FSP, Regional Head, Country Head, and other cross-functional stakeholders • Coordinate country functional teams for successful portfolio delivery • Ensure inspection readiness and provide hands-on support during inspections, including responsibility for storyboards • Sponsor continuous operational improvement, digital innovation, and adoption of leading practices • Direct resource strategy, capacity planning, and workload allocation across FSP and FTE LSOM teams • Ensure compliance with regulatory, GCP, ICH, quality, and organizational standards • Lead, coach, and develop LSOM Senior Managers, including performance management and talent development • Foster a high-performing, inclusive, accountable, and patient-focused culture across geographically distributed teams • Lead organizational changes and adoption of new operating models and technologies

🎯 Requisitos

• Doctorate degree and 4 years of clinical research experience OR Master’s degree and 7 years of clinical research experience OR Bachelor’s degree and 9 years of clinical research experience • 4 years of direct managerial and/or leadership experience or equivalent • Deep knowledge of ICH GCP, ICH E6(R3), ICH E8(R1), and global regulatory expectations for risk-based monitoring and clinical trial oversight • Proven ability to influence senior stakeholders and lead complex cross-functional initiatives within a global matrix organization • Strong Project Management experience • Experience managing multiple teams / direct reports across multiple clinical functions / trials • Experience at, or oversight of, clinical research vendors (CROs, central labs, imaging vendors, etc.) • Experience managing clinical operations across relevant geography / region • Strong understanding of local regulatory requirements around global clinical trials

🏖️ Benefícios

• Comprehensive employee benefits package • Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • Discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Financial plans with opportunities to save towards retirement or other goals • Career development opportunities • Work/life balance support • Reasonable accommodations for applicants and employees with disabilities

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