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Operational Design Lead

4 months ago

Washington, Washington, D.C., United States Amgen Full time

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.

Operational Design Lead

Live

What you will do

Lets do this. Lets 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 WinWhat 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 Masters degree and 2 years of clinical research experience OR Bachelors degree and 4 years of clinical research experience OR Associates 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 ThriveWhat 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. #obesity