HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.Manager, Clinical Research Pharmacy ServicesLive
What you will do
Lets do this. Lets 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, monitor dosing deviation/pharmacy trends and risk indicators, and support CRPS annual goals and process improvement initiatives.
- Support the annual review and update programs for Investigational Product Instruction Manuals (IPIMs) and IP Documentation
- Act as the First Point of Contact for Sites and Internal Partner queries on IP administration, formulation preparation, labeling, and/or packaging
- Lead Presentations for IP information at Investigator Meetings and Site Initiation Meetings
- Support the Clinical Research Pharmacy Services (CRPS) Senior Managers on Program Strategy and Continuous Process Improvement Initiatives
- Review and trend Dosing Deviations and Root Causes at Study, Program, and Portfolio levels to identify risk indicators and mitigation plans
- Support internal partners and 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
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:
Masters degree and 3 years experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials
Bachelors degree and 5 years experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials
Associates degree and 10 years experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials
High school diploma or GED and 12 years experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials;
Previous managerial experience directly managing people and/or experience leading teams, projects, programs, or directing the allocation of resourcesPreferred Qualifications:
- 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
- Strong 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
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!careers.amgen.com
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.