Clinical Research Pharmacy Svcs Sr Mgr

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Clinical Research Pharmacy Svcs Sr Mgr

What you will do

Lets do this. Lets change the world. In this vital role you will be responsible for supporting Amgens diverse portfolio of Investigational Products and provide guidance and support to internal groups and clinical sites on clinical trial preparation and administration methods.

You will be joining a global team 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. You will also drive and contribute to continuous process improvement relating to Investigational Product.

This role is based in Global Development Operations and supports Clinical Program Operations (CPO) to develop Investigational Product (IP) documentation and training and assist with the resolution of IP quality issues across sites. Monitoring dosing deviation/pharmacy trends and risk indicators, you will also partner with process development and Global Clinical Supply Chain Management (GCSCM) to optimize labeling and packaging of IP and provide insight into how IP is handled at clinical sites.

• Recruiting, leading and developing direct reports
• Allocating appropriate resources for Cluster team management
• Actively contributing to the strategic direction of CRPS and GDO to ensure safe, high quality and compliant Clinical Trial execution.
• Driving quality within studies for IP management processes, documentation and training
• Advising and supporting key partners to ensure IP Management practices are followed at global sites in line with GCP, ensuring patient safety and data integrity.
• Advising key partners on clinical site practices/perspectives to safely incorporate these practices into clinical trial design.
• Identifying and managing Risk for IP management related activities within individual Clinical Trial design and execution as well as across programs and processes.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The highly competent professional we seek is a go getter with these qualifications.

Doctorate degree and 2 years of experience. OR Masters degree and 6 years of experience OR Bachelors degree and 8 years of experience OR Associates degree and 10 years of experience OR High school diploma / GED and 12 years of experience

• PharmD or equivalent degree
• 9 years work experience in life sciences or medically related field, including 6 years 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 and sterile product compounding
• Strong interactions or work experience in a biopharmaceutical compliance department
• 2 years experience in a project leadership role and/or experience in leading when creating new or developing existing services
• 2 years management or leadership experience
• Pro-active problem identification and resolution experience

• Familiarity with advanced concepts of Clinical Research
• Extensive knowledge of ICH/GCP regulations and guidelines
• Strong knowledge of clinical trial operations
• Computer and system operation skills
• Relevant therapeutic area education and training
• Detailed understanding of customer service
• Demonstrated ability to anticipate and resolve problems
• Ability to write and present clearly using scientific and clinical issues terminology

• Demonstrated ability to work independently with minimal supervision
• Results oriented and goal driven
• Exceptional oral and written communication skills
• Ability to organize, interpret and communicate department information both cross-functionally and to local senior management
• Excellent organizational and planning skills
• Ability to identify and resolve complex problems

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 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

for a career that defies imagination

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

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 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.