Study Delivery Sr Mgr (Study Delivery Lead)

Amgen SA; Northern (KY); On-site; USD 164,000 - 197,000; Full time

Benefits offered by this job

Total Rewards Plan

Flexible work models

Retirement and Savings Plan

Medical/dental/vision coverage

Job summary

Amgen seeks a Study Delivery Senior Manager to own global clinical trial delivery and translate objectives into executable plans ensuring timely, high-quality data. You will manage end-to-end delivery of assigned studies with accountability for quality, timelines, budget, and performance.

You will lead cross-functional teams, define study plans, manage risks, and oversee enrollment and data flow while collaborating with vendors and internal partners to ensure compliance and continuous

Qualifications

• Doctorate, Master’s, Bachelor’s, Associate, or High school diploma with 12 years of Clinical Execution experience
• Experience leading global clinical trials in biotech/pharma/CRO
• Experience managing direct reports across geographies
• Experience representing sponsor in regulatory audits/inspections
• Experience overseeing external vendors (CROs, labs, imaging)

Responsibilities

• Lead cross-functional study teams to deliver high-quality clinical data
• Define study plans including feasibility, site selection, engagement, recruitment, retention, and vendor delivery
• Identify and manage study risks; apply risk-based approaches for safety and data integrity
• Oversee global study execution including enrollment, data flow, monitoring, and corrective actions
• Provide leadership, escalation, and issue resolution across geographies
• Build partnerships with internal and external stakeholders for collaboration and performance
• Champion continuous improvement, innovation, and regulatory compliance across trial delivery

Skills

Leadership

Regulatory experience

Cross-functional collaboration

Risk management

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

Vendor management

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. 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.

Study Delivery Senior Manager - Study Delivery Lead

What you will do

Let’s do this. Let’s change the world. In this vital role, you will take ownership of global clinical trial delivery, translating product and clinical objectives into executable plans that enable delivery of timely, high-quality data, in support of Amgen’s mission to serve patients. Own end-to-end delivery of assigned clinical studies, with accountability for quality, timelines, budget, and operational performance.

• Lead and align cross‑functional study teams to deliver high‑quality clinical data in line with the evidence generation strategy.
• Define and implement study plans inclusive of feasibility, site selection, site engagement, recruitment and retention, and vendor delivery.
• Proactively identify and manage study risks, driving quality-by-design and risk-based approaches to ensure participant safety and data integrity.
• Oversee global study execution, including enrollment, data flow, monitoring, and corrective actions where needed.
• Provide clear leadership, direction, and escalation management to resolve complex study issues across geographies.
• Build strong partnerships with internal stakeholders and external vendors, ensuring effective collaboration and performance.
• Champion continuous improvement, innovation, and regulatory compliance across all phases of clinical trial delivery.

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 2 years of Clinical Execution experience

Or

Master’s degree and 4 years of Clinical Execution experience

Or

Bachelor’s degree and 6 years of Clinical Execution experience

Or

Associate’s degree and 10 years of Clinical Execution experience

Or

High school diploma / GED and 12 years of Clinical Execution experience

Preferred Qualifications:

• 7 years’ work experience in life sciences or medically related field, including 5 years of biopharmaceutical clinical research experience obtained leading global clinical trials in a biotech, pharmaceutical or CRO company
• Experience managing direct reports across multiple geographies
• Experience representing a sponsor company in regulatory audit/inspections
• Experience at or oversight of outside clinical research vendors (CRO’s, central labs, imaging vendors, etc.)

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 expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $163,721 USD to $197,116. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.

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:

• 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. Refer to the Work Location Type in the job posting to see if this applies.

In any materials you submit, you may redact or remove age‑identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Sponsorship

Sponsorship for this role is not guaranteed.

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.