Clinical Risk Management Assoc Dir

1 month ago


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

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 DirectorLive

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 programsKey Responsibilities:

Lead and oversee the management and evolution of the CT-RACT Global Library risks and critical processes, including cross-functional strategyAccountable for governance structure and procedures (e.g., global library, quality review and adherence, cross functional input, reporting and documentation procedures) associated with clinical risk managementInfluence evolving strategy and process for feedback loop to inform future study design and implementation with key partnersResponsible for the trending analysis for Clinical Risk Management quality and FSP quality oversight reviewsEnsure resolution of performance issues for the FSP Clinical Risk Managers and monitoring of Clinical Risk Manager FSP Key Performance IndicatorsDevelopment of Key Performance Indicators (KPIs), operational consistency and risk management cross functional complianceDevelop study specific Key Risk Indicators (KRI), thresholds decision tree and trending strategyLine management of Amgen Clinical Risk Managers, incl. Goal Setting, Career Development Plans (CDPs) and Succession PlanningWinWhat 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 & 2 years of directly related experience orMasters degree & 6 years of directly related experience orBachelors degree & 8 years of directly related experience orAssociates degree & 10 years of directly related experience orHigh school diploma / GED & 12 years of directly related experience and2 years of direct managerial and/or leadership experiencePreferred Qualifications:BS/BA/BSc in the sciences or RN12 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 companyPrevious management experience of direct reportsExperience at or oversight of outside clinical research vendors (CROs, central labs, imaging vendors, etc.)Experience driving and leading process development and /or improvementThriveWhat 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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor 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.

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