Amgen • Washington, DC 20080
Job #2693629760
HOW MIGHT YOU DEFY IMAGINATION?
You've 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 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Operational Design Lead
Live
What you will do
Let's do this. Let's change the world. The Development Operations, Manager (Operational Design Lead), is a pivotal role in Clinical Program Operations supporting study teams during late-phase key design element (KDE) and protocol development.
Responsibilities
Utilize expertise in clinical operations and strategic planning to lead the team through clinical development study design, operational study start-up timelines, and risk path implication
Collaborate with teams to ensure KDE and protocol authoring timelines adhere to established processes and align with the clinical development strategic plan
Facilitate essential decisions concerning study design to guide the operational strategy, incorporating operational considerations, while assessing and highlighting downstream impacts
Promote collaborations across study team to ensure cross-functional stakeholder engagement, contribution and document review
Ensure partnership among study team and data teams to promote evidence-based decision-making and operational optimization through integration of data and patient voice utilization
Assess and mitigate risks to regulatory and operational timelines by actively monitoring and evaluating disconfirming information
Demonstrate external knowledge of industry standards, processes and new trends
Contribute 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 OR
Master's degree and 2 years of clinical research experience OR
Bachelor's degree and 4 years of clinical research experience OR
Associate's degree and 8 years of clinical research experience OR
High school diploma / GED and 10 years of clinical research experience
Preferred Qualifications:
7+ years work experience in life sciences or medically related field, including 4+ years of biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company
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 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.
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.
~~~
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.
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