Manager, Clinical Research Pharmacy Services

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Manager, Clinical Research Pharmacy Services

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, to monitor dosing deviation / pharmacy trends and risk indicators, and to 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 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 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

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:

Doctorate degree

Masters degree and 3 years of life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials experience

Bachelors degree and 5 years of life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials experience

Associates degree and 10 years of life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials experience

High school diploma / GED and 12 years of life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials experience

Preferred 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

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

• A 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
• Flexible work models, including remote and hybrid work arrangements, where possible

for a career that defies imagination

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

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

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. 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.