Senior Manager, Local Study 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

• Lead the skill development of Local Study Operations Managers (LSOMs) and ensure effective trial implementation within the country • Oversee delivery of the country’s study portfolio, including scope, timelines, and budgets, through LSOM leadership • Foster and sustain an optimal clinical research environment aligned with global R&D objectives • Drive alignment and continuous improvement in LSOM execution through best practices, digital innovation, and knowledge sharing • Ensure successful delivery of the study portfolio assigned to LSOMs • Oversee LSOM responsibilities from feasibility through study close-out • Monitor portfolio progress and provide risk and quality oversight • Support issue escalation and resolution • Manage LSOM and vendor performance and serve as the primary escalation point for local study challenges • Mentor, train, and support LSOM professional development • Build and maintain a high-performing team • Facilitate collaboration between study strategy and local study teams • Promote cross-functional collaboration among country teams • Support study placement decisions based on country capabilities and growth potential • Evaluate risks, quality trends, and resource requirements; implement mitigation strategies • Lead operational efficiency and best-practice initiatives • Manage resource allocation and workload distribution across LSOMs, including FSP and FTE personnel • Ensure adherence to regulatory and quality standards • Support the country head in stakeholder engagement, trial deliverables, and escalations

🎯 Requirements

• Doctorate degree and 2 years of clinical execution experience, or Master’s degree and 6 years, or Bachelor’s degree and 8 years, or Associate’s degree and 10 years, or high school diploma/GED and 12 years • Minimum 2 years of direct people management or leadership experience leading teams, projects, programs, or resource allocation • Advanced English proficiency • Preferred: 7 years of work experience in life sciences or a medically related field • Preferred: 4 years of biopharmaceutical clinical research experience working on clinical trials in a biotech, pharmaceutical, or CRO company • Experience managing multiple teams or direct reports across multiple clinical functions or trials • Experience overseeing clinical research vendors, including CROs, central labs, and imaging vendors • Experience managing clinical operations across relevant geography/region • Strong understanding of local regulatory requirements for global clinical trials

🏖️ Benefits

• Health and welfare plans for staff and eligible dependents • Financial plans with opportunities to save towards retirement or other goals • Work/life balance support • Career development opportunities • Reasonable accommodation for individuals with disabilities • Inclusive and collaborative culture