Global Clinical Program Management Sr. Manager - Observational Research (US or UK based)

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

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.

Global Clinical Program Management Sr. Manager - Observational Research (US based)

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will coordinate and oversee the operational strategy, planning, risk assessment and mitigation, and overall execution of observational research studies within CPO-OR (Observational Research).

Responsible for:

• Oversee people management, career development, training and succession planning of Amgen GTMs supporting the Observational Research Portfolio
• Support CPO resource planning for Observational Research portfolio in collaboration with CPO/OR Director, PRM and FSP Partners.
• Oversee the operational execution, design, planning, risk assessment and mitigations of assigned observational research (OR) studies
• Oversight of assigned OR study budgets including change control in collaboration with TA Governance and Finance.
• Ensure strong relationships and alignment with TA, GSO, CfOR, Safety, and HE representatives, maintaining and improving global collaboration and consistency
• Providing clinical operations leadership and expertise on the Product Teams (PTs) Key Evidence Generation Teams (KEGs) and Evidence Generation Teams (EGTs) as requested.
• Support the identification of outsourcing requirements and oversee the evaluation, selection, setup, and management of vendors for observational studies
• Contribute operational expertise ensuring operational feasibility throughout study design process, including KDE and Protocol Development.
• Provide advice as requested on core study documents prior to Governance Body review.
• Lead the Country Operational Landscape Assessments and study feasibility with Feasibility Director (study level)
• Oversee and approve study global enrollment baselines and accurate global recruitment forecasting
• Support fit for purpose OR operating model by identifying process gaps or improvements with the development of new processes, authoring. Review of SOPs, Work Instructions, FORMS, templates and training.
• Support and coordinate audit and inspection activities and contributes to CAPAs ensuring the update of processes where vital and appropriate verifications.
• Communicate effectively with key team members to ensure operational strategy alignment and contribute to functional goal setting within the program.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a driven individual with these qualifications.

Basic Qualifications:

• Doctorate degree & 2 years of life sciences or medically related field OR
• Master’s degree & 6 years of life sciences or medically related field OR
• Bachelor’s degree & 8 years of life sciences or medically related field OR
• Associate’s degree & 10 years of life sciences or medically related field OR
• High school diploma / GED & 12 years of life sciences or medically related field AND
• 2 years of direct managerial and/or leadership experience

Preferred Qualifications:

• BS/BA/BSc in the sciences or RN
• 9 years work experience in life sciences or medically related field, including 6 years of biopharmaceutical clinical research experience working on clinical trials at a biotech, pharmaceutical or CRO company
• Experience conducting and/or overseeing observational research execution in an industry setting
• Previous management experience of direct reports
• Experience at or oversight of outside clinical research vendors (CROs, central labs, imaging vendors, etc)
• Experience driving and leading process development and /or improvement

Thrive

What you can expect of us

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

Amgen offers a Total Rewards Plan comprising 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 including:

• Comprehensive employee