Local Study Operations Line Sr. Manager

Amgen Inc.; Thousand Oaks (CA); Hybrid; USD 152,000 - 206,000; Full time

Job summary

Amgen Inc. in Thousand Oaks, CA is seeking a Local Study Operations Senior Manager to lead study portfolio delivery and oversee LSOMs from feasibility to close-out.

You will drive risk and quality oversight, mentor staff, and ensure high-quality trial execution across the country. The role emphasizes cross-functional collaboration, resource planning, and alignment with global priorities while upholding regulatory standards.

Qualifications

• Doctorate or Master’s degree with clinical execution experience is required.
• Experience coordinating clinical trial activities across geography and teams.
• Strong understanding of regulatory requirements in global trials.

Responsibilities

• Ensure successful delivery of the LSOM study portfolio.
• Oversee LSOMs from feasibility through study close-out.
• Monitor portfolio progress with risk and quality oversight.
• Manage LSOM and vendor performance; escalate and resolve issues.
• Mentor LSOMs and support professional development.
• Build and maintain a high-performing team.
• Foster cross-functional collaboration across country teams.
• Optimize resource allocation and workload distribution.
• Ensure adherence to regulatory and quality standards.

Skills

Clinical trial management

Team leadership

Vendor management

Regulatory understanding

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate degree

High school diploma

Job description

Career Category Clinical Job Description Join 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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 Line Sr. Manager

What you will do

Let’s do this. Let’s change the world. . Let’s change the world.

• Ensure the successful delivery of the study portfolio assigned to LSOMs.
• Oversee LSOMs’ fulfillment of responsibilities throughout the assigned country portfolio, from feasibility through to study close‑out.
• Monitor portfolio progress, provide risk and quality oversight, and support issue escalation and resolution for LSOMs.
• Manage LSOM and LSOM vendor performance to guarantee high‑quality study execution, serving as the primary escalation point for local study challenges, driving solutions, and ensuring portfolio targets are met within the country.
• Mentor, train, and support the professional development of LSOMs to prepare them for managing complex trials.
• Build and maintain a high‑performing team.
• Facilitate close collaboration between the study strategy team and local study teams to effectively manage the assigned portfolio.
• Promote cross‑functional collaboration among country teams to ensure successful delivery of the country portfolio.
• Support discussions regarding study placement decisions based on country capabilities and growth potential.
• Proactively evaluate risks, quality trends, and resource requirements; implement mitigation strategies and drive continuous improvement in country operations.
• Lead initiatives to enhance operational efficiency and encourage sharing of best practices.
• Manage resource allocation and workload distribution across LSOMs, including both FSP and FTE personnel, to optimize trial execution and align with global priorities.
• Ensure adherence to regulatory and quality standards where applicable.
• Collaborate with and support the country head in engaging cross‑functional stakeholders, aligning on trial deliverables, and managing escalations.

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 & 2 years of clinical execution experience
• Master’s degree & 6 years of clinical execution experience
• Bachelor’s degree & 8 years of clinical execution experience
• Associate’s degree & 10 years of clinical execution experience
• High school diploma / GED & 12 years of clinical execution experience

Preferred Qualifications

• 7 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Experience managing multiple teams / direct reports across multiple clinical functions / trials
• Experience at, or oversight of, clinical research vendors (CRO’s, central labs, imaging vendors, etc.)
• Experience managing clinical operations across relevant geography / region, including strong understanding of local regulatory requirements around global clinical trials

What you can expect of us

A 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 Flexible work models where possible.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $151,988-$205,630. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Sponsorship

Sponsorship for this role is not guaranteed.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen