Operational Design Lead - Washington, United States - Amgen
Description
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 startup 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 crossfunctional stakeholder engagement, contribution and document review
- Ensure partnership among study team and data teams to promote evidencebased decisionmaking 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 tradeoffs 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.
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 salesbased incentive plan
- Stockbased longterm incentives
- Awardwinning timeoff plans and biannual companywide shutdowns
- Flexible work models, including remote work arrangements, where possible
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.
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