Study Oversight Senior Manager

Amgen SA; Northern (KY); Hybrid; USD 167,000 - 226,000; Full time

Benefits offered by this job

Retirement plan

Medical/dental/vision coverage

Bonus program

Stock incentives

Flexible remote work

Job summary

Amgen is seeking a Study Oversight Sr Mgr to manage all FSP resources (CRA, CTA, LSOM) to ensure quality, efficiency, and compliance. You will serve as secondary contact for FSP supplier concerns within the country.

This role includes mentoring SOM Managers, coordinating supplier capacity and portfolio planning from study startup to close-out, overseeing performance against metrics, and supporting inspection readiness and regulatory inspections where applicable.

Qualifications

• Doctorate or equivalent with clinical execution experience
• Advanced degree with leadership/management experience in clinical operations
• Experience supervising teams and resource allocation
• Knowledge of regulatory requirements for global clinical trials

Responsibilities

• Mentor, train, and support SOM Mgr development and leadership
• Serve as the country point of contact for FSP supplier resource and capacity management
• Oversee supplier performance and quality across study milestones
• Ensure readiness for inspections and regulatory audits when applicable
• Collaborate with global and local teams to maintain quality and alignment

Skills

People management

Leadership

Cross-functional collaboration

Project management

Quality assurance

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate’s degree

High school diploma

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 Oversight Sr Mgr

Let’s do this. Let’s change the world. You will be accountable for managing all FSP resources (CRA, CTA, LSOM) to ensure quality, efficiency, and adherence to compliance standards. As well as serve as the secondary contact and escalation point for all FSP supplier-related concerns within the country.

Responsibilities:

Mentor, train, and support the professional development of SOM Mgr

Serve as the point of contact for FSP supplier(s) resource and capacity management, portfolio planning

and prioritization from study startup to close-out at the country level

Ensures oversight of supplier performance (e.g., tracking against metrics, assuring overall quality of work performed by FSP staff)

Identification, escalation and resolution of quality and trial delivery issues

Collaborate with LSOMs Sn Mgs and/or LSOM AD to ensure appropriate level of staff oversight, maintaining quality throughout Amgen clinical trials (e.g., occasional on-site quality visits)

Ensure effective collaboration between SOM Mgs, driving consistent communication with FSPs, sites and alignment with global strategies

Escalate issues to the County-Hub Head GSSO

Aggregate & communicate country-wide issues through consolidating input from FSPs to provide country-aggregated view on FSP trends and challenges to senior management

Oversee management of FSP supplier performance covering study milestones achievement and quality targets

Supports inspection readiness

Supports local country site level audits and regulatory inspections when applicable

Supports maintenance of Amgen investigator site relationships in country

Participates in cross functional task force / process improvement groups

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 6 years of clinical execution experience OR
• Bachelor’s degree and 8 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
• In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

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 suppliers (CRO’s, central labs, imaging suppliers, 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

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

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.