Local Study Operations Manager TA Head

Job description

Career CategoryClinicalJob DescriptionJoin Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Local Study Operations Manager TA Head What you will do Let’s do this. Let’s change the world. In this role, you will lead and develop Local Study Operations Senior Managers, strengthening their leadership capabilities, functional expertise, and overall performance to ensure alignment with both global and country-level objectives. You will oversee the successful delivery of the country’s study portfolio—managing scope, timelines, and budgets—through effective guidance and support of the LSOM Senior Manager team. Working closely with the Country GSSO Head, you will help cultivate a strong clinical research environment that supports global R&D priorities. Additionally, you will drive strategic alignment and continuous improvement by standardizing processes across LSOM Senior Managers, promoting best practices, encouraging digital innovation, and facilitating the systematic sharing of knowledge and lessons learned across teams. Ensure the accountable delivery of the study portfolio assigned to LSOM Senior Managers. Oversee and guide the country study portfolio through effective leadership of LSOM Senior Managers, aligning execution with global strategies and local priorities. Provide strategic direction and support to LSOM Senior Managers in portfolio monitoring, driving local action plans, and resolving issues. Serve as the primary escalation point for complex or systemic local study challenges, facilitating resolution and ensuring portfolio targets are met with quality and efficiency. Lead the development and mentorship of LSOM Senior Managers to equip them for effective team leadership and operational excellence. Build and maintain a high-performing leadership team that promotes accountability, collaboration, and resilience across the LSOM organization. Facilitate close collaboration between global study strategy teams and local study teams to effectively manage the assigned portfolio. Oversee coordination among country functional teams to ensure successful delivery of the country portfolio. Support discussions on country study placements, considering country strengths and growth potential. Act as a key advisor for site selection, identifying priority sites and allocating resources accordingly. Support country-level risk assessments by proactively identifying and managing risks to delivery. Ensure inspection readiness and provide hands-on support during inspections, including responsibility for storyboards. Promote continuous operational improvements and encourage sharing of best practices. Manage resource allocation and workload distribution among LSOM Senior Managers and the broader LSOM team, including both FSP and FTE, to optimize trial execution and align with global priorities. Ensure compliance with relevant regulatory and quality standards. Collaborate with the country head to engage cross-functional stakeholders, align on trial deliverables, and manage escalations as needed. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an individual with the following qualifications. Basic Qualifications: Doctorate degree and 3 years of clinical execution experience OR Master’s degree and 7 years of clinical execution experience OR Bachelor’s degree and 9 years of clinical execution experience OR Associate’s degree and 12 years of clinical execution experience OR High school diploma / GED and 14 years of clinical execution experience In addition to meeting at least one of the above requirements, you must have a minimum of 3 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above Preferred Qualifications: +8 years work experience in life sciences or medically related field, including 6 years of biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company) Experience managing multiple teams / direct reports Experience at or oversight of outside clinical research vendors (CRO’s, central labs, imaging vendors, etc.) Experience working on global clinical trials, with highly effective communications skills and track record for improving site engagement, improving relationships with investigators, and operational efficiency What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The annual base salary range for this opportunity in the U.S. is $167,187-$226,194. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .Salary Range USD - USD