Clinical Program Operations (CPO) Non-Amgen Sponsored Clinical Research (NASCR) Manager

If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

MANAGER, CLINICAL PROGRAM OPERATIONS (CPO) Non-Amgen Sponsored Clinical Research (NASCR)

What you will do

In this vital role you will join a dynamic team in a company that cultivates and encourages individual career development. The Non-Amgen Sponsored Clinical Research (NASCR) Manager position supports operational activities related to Investigator Sponsored Studies (ISS) and Expanded Access (EA) in compliance with relevant Standard Operating Procedures (SOPs) and Guides (GDEs).

• Ensuring NASCR supported activities are conducted in accordance with Global ISS SOP and GDE controlled documents.

• Collaborating with Global Development TA and the Global Medical Organization to ensure timely and appropriate support of NASCR activities.

• Coordinate the management of ISS proposals and protocols and facilitating their review/approval against target cycle timelines.

• Tracking and handling of study budgets, timelines, amendments, and payments to required standards.

• Participating in Study Start-up activities and delivering sponsor support according to required standards.

• Serving as a point of contact for regional NASCR issues related to your product portfolio and leading performance monitoring efforts.

• Closely collaborate with a wide range of stakeholders across Amgen, such as Regulatory Affairs, Safety & Pharmacovigilance Operations, Supply Chain, Law, Medical, Biostatistics, and Finance.

• Escalating and troubleshooting ISS and EA process issues, as appropriate, with the NASCR Senior Manager.

• Assisting the NASCR Senior Manager with global NASCR initiatives, such as process improvement, related to ISS and EA.

• Mentoring NASCR group regional staff and GSO affiliate staff.

• Partnering with NASCR Senior Associates to effectively supervise and deliver ISS portfolios for products aligned with therapeutic areas.

You would be joining the Non-Amgen Sponsored Clinical Research (NASCR) team, responsible for supporting the complete life cycle of Investigator-Sponsored Studies (ISS) across Amgen Therapeutic Areas. The team operates in a fast-paced, innovative, and collaborative environment, working with both licensed and unlicensed products. The NASCR Manager role sits within the Clinical Program Operations (CPO) function in Global Development Operations (GDO) and reports into the NASCR Snr Manager role.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:
 

• Degree educated, BS/BA/BSc in the sciences or RN.

• Strong track record of experience in life sciences or a medically related field, including biopharmaceutical, clinical research, or clinical operations experience (experience acquired working on clinical trials at a biotech, pharmaceutical or CRO company).

• Experience working on Investigator-Sponsored Research, Industry-Sponsored, or Industry-Partnered clinical trials, or working on clinical trials at a Biotech, Pharmaceutical, or CRO company.

• Experience in the oversight of external vendors (CROs, central labs, imaging vendors, etc.).

• Good understanding of regulatory frameworks within the EU relevant to ISS.

• Problem Solving and solution orientated attitude.

• Positive relationship building and communication skills.

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization.

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.

• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits.

Objects in your future are closer than they appear. Join us.

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a 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 an accommodation.