Executive Director – Global Site & Study Operations

Job not on LinkedIn

🔥 12 hours ago

🏄 California – Remote

🏄 California – Remote

💵 $263.8k - $356.9k / year

⏰ Full Time

🔴 Lead

⚙️ Operations

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• Provide regional Study & Site Operations leadership across the Americas clinical trial portfolio • Set enterprise-level strategic direction and provide operational oversight, people leadership, and cross-functional influence • Lead regional and country/hub leaders and represent the region in global governance and portfolio decision-making forums • Oversee initiation, management, quality, and completion of Phase I-IV clinical trials across the region • Guide modern site-monitoring approaches and associated resource strategies • Provide insights informing portfolio, program, and study-planning decisions • Build and develop a high-performing Country/Hub head team • Champion innovation and continuous improvement in study start-up approaches, digital solutions, predictive analytics, and harmonized ways of working • Implement the Regional Study & Site Operations strategy and allocate study resources according to global priorities • Optimize deployment of internal and staff-augmented resources across clinical programs • Provide executive oversight of high-risk or strategically important clinical programs • Act as the GSSO escalation point for study risks and issues and guide mitigation strategies and scenario planning • Build and sustain a CRA monitoring organization • Ensure appropriate use of centralized, on-site, and remote monitoring, targeted SDR/SDV, and risk/quality indicators • Strengthen relationships with clinical research sites and improve site experience and performance • Make decisions on regional study and site operations, resource allocation, budget utilization, and vendor performance • Oversee the regional clinical trial portfolio from study start-up through enrollment, execution, database lock, and closeout • Ensure inspection readiness throughout the clinical trial lifecycle and follow through to audits and inspections • Represent GSSO and/or the region in global governance bodies • Lead, coach, and develop regional and country Study & Site Operations leaders • Manage performance, succession planning, leadership bench development, and organizational capability building • Foster a high-performing, inclusive, accountable, and patient-focused culture across geographically distributed teams • Lead organizational change and adoption of new operating models, technologies, monitoring approaches, and clinical development practices • Identify process simplification and productivity opportunities using data and performance insights • Lead or sponsor regional and global clinical operations transformation initiatives • Partner with Clinical Development, Operations, Regulatory, and regional leaders to align study start-up strategy and resources • Promote GSSO as a strategic enabler of faster and more predictable clinical trial execution

🎯 Requirements

• Doctorate degree & 6 years of global site study experiences OR Master’s degree & 10 years of global site study experiences OR Bachelor’s degree & 12 years of global site study experiences • 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources • Bachelor’s degree in life sciences, pharmacy, nursing, medicine, or a related discipline required; advanced degree preferred • 15+ years of progressive experience in pharmaceutical, biotechnology, CRO, or clinical research organizations • Extensive clinical operations and study management experience across multiple phases of clinical development • Significant leadership experience managing managers and/or large, geographically distributed clinical operations organizations, inclusive of a monitoring organization • Demonstrated experience overseeing complex global or regional clinical trial portfolios • Demonstrated experience with CRO/vendor governance, outsourcing models, budget management, and resource planning • Track record of leading organizational change and improving clinical operations performance • Strong knowledge of ICH-GCP, clinical development processes, and applicable regulatory requirements • Experience supporting regulatory inspections and clinical quality management • Experience working for or overseeing clinical research vendors (CROs, central laboratories, imaging vendors, etc.) • Experience managing clinical operations across the relevant geography/region, including strong understanding of local regulatory requirements around clinical trials • Ability to navigate cross-geographic and cultural dynamics and lead efficient global teams • Demonstrated ability to motivate geographically dispersed teams inclusively and drive strategy and execution • Experience delivering portfolio/cross-study budgets, timelines, and performance metrics • Experience assessing internal capabilities and leading continuous improvement initiatives • Experience leading organizations through cross-functional change initiatives • Exceptional communication and influence skills • Ability to build partnerships with Clinical Development, Medical, Regulatory Affairs, Safety, Biometrics, Data Management, Clinical Supply, Quality, and other functions • Ability to communicate portfolio performance, risks, and strategic recommendations clearly to senior leadership

🏖️ Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • A discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Bi-annual company-wide shutdowns • Flexible work models where possible • Career development opportunities • Financial plans with opportunities to save towards retirement or other goals • Work/life balance