Study Start-up Manager

Career Category Clinical Job Description 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 Start Up Hub – Study Start-up Mgr

What you will do

Let’s do this. Let’s change the world. In this vital role you will drive the planning and execution of clinical study start-up activities, ensuring trials are launched efficiently, compliantly, and to the highest quality standards. Lead the planning and delivery of clinical study start-up activities from global to local, ensuring timelines, quality, budget, and regulatory compliance are met. Own and manage study start-up plans and milestones, maintaining oversight of progress and resolving issues to keep delivery on track. Act as the primary point of contact for cross-functional start-up teams, driving clarity of roles, accountability, and collaboration. Identify, assess, and mitigate risks proactively, contributing to study risk assessments and ensuring timely study start. Partner closely with Study Delivery Leads, managers, and local teams, providing clear updates, solutions, and escalation where needed. Apply strong operational and regulatory knowledge (e.g. ICH-GCP, submissions and start-up processes) to enable high-quality execution. Manage internal resources and external suppliers to ensure efficient and compliant delivery of start-up activities. Contribute to continuous improvement by sharing expertise, mentoring colleagues, and developing best practices within the SSU hub.

What we expect of you

• Pharma Expertise: Requires pharma and clinical trial processes and operations expertise; no relevant therapeutic knowledge required
• Management Experience: Requires experience leading and managing global teams and project management experience
• Tech Skills: No prior Veeva experience required

Doctorate degree OR Master’s degree and 3 years of clinical execution experience OR Bachelor’s degree and 5 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 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

• 5 years work experience in life sciences or medically related field, including 3 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Experience working in global clinical trial teams across multiple geographies
• Experience with risk-based monitoring models / risk-based quality management, and/or clinical site management
• PMP Certification

What you can expect of us

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 [Talent Acquisition to input market pay range]. 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

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.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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

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