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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Senior Manager, Clinical Research Pharmacy Services

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will work in partnership with Global Clinical Program Management (GCPM) and Early Development to develop Investigational Product (IP) documentation and training, to monitor dosing deviation / pharmacy trends and risk indicators, and to support Clinical Research Pharmacy Services (GCPS) annual goals and process improvement initiatives.

• Development of study or IP-specific training materials for CRAs and sites (including supporting the annual review and update programs for IPIMs and IP Documentation)
• Provide input and support to the IP Management Network
• Provide input and support into the design of IP sections of study protocols
• Assist in developing training tools for clinical sites for studies with complex dosing regimens
• Provide input and feedback on drug packaging and labelling proposals for clinical studies discussed at the DDC
• Respond to audit findings related to IP dosing
• Lead Presentations for IP information at Investigator Meetings and Site Initiation Meetings
• Develop Program Strategy and Continuous Process Improvement Initiatives
• Review and trend Dosing Deviations and Root Causes at Study, Program and Portfolio level to identify risk indicators and mitigation plans
• Support internal partners & networks to promote greater cross functional understanding and insight into clinical IP needs, IP presentation and preparation challenges
• Maintain a good working relationship with external depots (e.g., GCSCM ABR and ATO) and clinical logistics
• Lead Presentations on behalf of CRPS with cross-functional partners speaking to new initiatives related to IP development and management

Be part of our Clinical Research Pharmacy Services Team:

The Clinical Research Pharmacy Services team is a highly talented group of Investigational Product Preparation and Administration specialists dedicated to oversight of Investigational Product in Amgen Studies. This team has an intimate understanding and insight into trial site practice, provides Investigational Product clinical services and relays how Investigational Product should be handled and managed within clinical sites. The team drives and contributes to continuous process improvement relating to Investigational Product. 

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The self-confident professional we seek is a partner with these qualifications.

Basic Qualifications:

• Certified pharmacist or pharmacy degree
• Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials

Preferred Requirements:

• Broad work experience in life sciences or medically related field, including biopharmaceutical clinical research experience working on clinical trials at a biotech or pharmaceutical company
• Practical experience in a clinical research setting working on complex clinical programs in a pharmacy at an investigational site
• Experience with drug formulations, sterile product compounding and administration practices
• Relevant therapeutic area education (oncology preferred) and training
• Knowledge of ICH/GCP regulations and guidelines
• Extensive knowledge of clinical trial operations
• Computer and system operation skills
• Demonstrated ability to anticipate and resolve problems
• Ability to write, communicate and present clearly using scientific and clinical issues terminology
• Strong interactions or work experience in a biopharmaceutical compliance department
• Experience in a project leadership role
• Staff management and development needs

Thrive

Some of the vast rewards of working here

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.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A 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—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

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

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Equal Opportunity Statement