Clinical Risk Management Assoc Dir

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Clinical Risk Management Associate Director

What you will do

Lets do this. Lets change the world. In this vital role you will oversee the strategy of risk management for all clinical trials and programs managed by Global Development Operations (GDO), covering early, late and observational programs

• Lead and oversee the management and evolution of the CT-RACT Global Library risks and critical processes, including cross-functional strategy
• Accountable for governance structure and procedures (e.g., global library, quality review and adherence, cross functional input, reporting and documentation procedures) associated with clinical risk management
• Influence evolving strategy and process for feedback loop to inform future study design and implementation with key partners
• Responsible for the trending analysis for Clinical Risk Management quality and FSP quality oversight reviews
• Ensure resolution of performance issues for the FSP Clinical Risk Managers and monitoring of Clinical Risk Manager FSP Key Performance Indicators
• Development of Key Performance Indicators (KPIs), operational consistency and risk management cross functional compliance
• Develop study specific Key Risk Indicators (KRI), thresholds decision tree and trending strategy
• Line management of Amgen Clinical Risk Managers, incl. Goal Setting, Career Development Plans (CDPs) and Succession Planning

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.

• Doctorate degree & 2 years of directly related experience or
• Masters degree & 6 years of directly related experience or
• Bachelors degree & 8 years of directly related experience or
• Associates degree & 10 years of directly related experience or
• High school diploma / GED & 12 years of directly related experience and
• 2 years of direct managerial and/or leadership experience

• BS/BA/BSc in the sciences or RN
• 12 years work experience in life sciences or medically related field, including 8 years of biopharmaceutical clinical research experience working on clinical trials at a biotech, pharmaceutical or CRO company
• Previous management experience of direct reports
• Experience at or oversight of outside clinical research vendors (CROs, central labs, imaging vendors, etc.)
• Experience driving and leading process development and /or improvement

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 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

for a career that defies imagination

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

Amgen anticipates accepting applications until August 23, 2024; however, we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates.

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.