Director, Local Study Operations Manager

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $195.9k - $265k / 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 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

🎯 Requirements

• 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

🏖️ Benefits

• 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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