Job Information
Amgen Operational Design Lead in Thousand Oaks, California
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.
Operational Design Lead
Live
What you will do
Let’s do this. Let’s change the world. The Development Operations Senior Manager - Operational Design Lead, is a pivotal role in Clinical Program Operations supporting study teams during late-phase KDE and protocol development. The Operational Design Lead coordinates and oversees the development of operationally integrated study protocols, using expertise in clinical operations and strategic planning to ensure protocols are aligned with the overall clinical development strategy.
Responsibilities:
Expertly guide the study team on study design, operational study start up timelines, and risk path implication and facilitate crucial decisions concerning study protocol design to guide the operational strategy, incorporating operational considerations, while highlighting the downstream impacts of design decisions
Drive collaboration and integration among study teams and development data teams to promote evidence based decision making and operational optimization through data utilization
Identify and mitigate regulatory and operational timeline risks by assessing and monitoring disconfirming information throughout study design
Facilitate necessary study protocol design decisions to inform the operational plan and ensures that operational considerations are included in protocol development (highlighting downstream impact of design decisions)
Identify need for missing cross-functional input, information or data and facilitates effort to obtain it and demonstrate external knowledge of industry best practices, processes and new trends
Define and chip in to the continuous improvement of study design, feasibility and planning processes and study operational execution
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a driven individual with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of clinical research experience, or
Master’s degree and 6 years of clinical research experience, or
Bachelor’s degree and 8 years of clinical research experience or
Associate’s degree and 10 years of clinical research experience or
High school diploma / GED and 12 years of clinical research experience
Preferred Qualifications:
9+ years work experience in life sciences or medically related field, including 6+ years of biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company
Experience at or oversight of outside clinical research vendors (CRO’s, central labs, imaging vendors, etc.) and strong background in clinical operations with clinical trial experience
Experience leading cross-functional teams in a matrix organization with strong delivery of results
An understanding of the trade-offs between optimal study design to meet strategic objectives, operational efficiency and cost and ability to facilitate a team discussion to reach decisions and clear outputs
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.
The annual base salary range for this opportunity in the U.S. is [input market pay range $146,430-170,831.
In addition to the base salary, 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
Apply now
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.
Join Us
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancers, kidney disease, rheumatoid arthritis and other serious illnesses.
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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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, 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.