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Diagnostic Strategy Lead, Heme-Onc - Director

Company: Amgen
Location: Thousand Oaks
Posted on: August 18, 2019

Job Description:

We are building upon our solid heme-onc foundation and long-term commitment to patients by developing a whole new class of novel molecules - and we need top talent to ensure these molecules become medicines and realize their potential for helping patients.Amgen is searching for a Diagnostic Strategy Lead, Heme/Onc - Director.This individual will be responsible for the development and implementation of the In Vitro Diagnostic strategies and will work out of either our Thousand Oaks or South San Francisco research sites.Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.Integral to the ongoing success of Amgen's growing pipeline, the In Vitro Diagnostics (IVD) Group is responsible for the successful transition of a biomarker assay to marketed IVD to support the clinical development strategy for regulatory approval and commercialization. As such, the IVD group works closely with other functions within Amgen to identify the appropriate partners for diagnostic test development. We are looking for individuals with experience in driving end - to - end diagnostic development strategies and development life cycle management plans that align to development needs of their corresponding precision therapeutics within the Heme/Onc therapeutic area. The Diagnostic Strategy Lead role will be a critical strategic role at Amgen requiring a breadth of technical and business communication expertise across a broad range of stakeholders, influencing decision-making through negotiation, and addressing conflict by building productive working relationships across functional areas both within and outside the company.The Diagnostic Strategy Lead, Heme/Onc will be responsible for:The end-to-end diagnostic development strategies for therapeutic product teams within the Heme/Onc therapeutic areaThe development and successful implementation of global strategic diagnostic development life cycle plans, programs and initiatives to support approval and commercialization of diagnostics which will support the therapeutic life cyclesDeveloping business cases, driving the strategic evaluation of diagnostic development options and technologies, diagnostic market landscape assessmentWorking with key cross-functional stakeholders to integrate diagnostic development, approval and launch strategies for the product teams together with third-party diagnostic partners and ensuring successful execution of the overall strategyEnsuring that the diagnostic strategy incorporates global requirements for execution and successWorking closely with global and regional marketing teams, and other cross functional partners and stakeholders, to deliver and implement regional and global diagnostic business strategiesBasic QualificationsDoctorate degree and 4 years of pharmaceutical and/or diagnostic experienceORMaster's degree and 7 years of pharmaceutical and/or diagnostic experienceORBachelor's degree and 9 years of pharmaceutical and/or diagnostic experiencePreferred Qualifications4+ years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resourcesExperience in oncology drug development and / or in vitro diagnostics developmentExperience in companion diagnostics development and knowledge of regulatory submission requirements of in vitro diagnostic devices in multiple marketsKnowledge and experience in clinical trial designExperience integrating data from multiple sources and identifying critical process variablesExperience establishing and reviewing complex plans for multiple projects or activities. This includes planning resource allocation and distribution and identifying contingency plans5+ years of experience in pharmaceutical industryOur culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Keywords: Amgen, Los Angeles , Diagnostic Strategy Lead, Heme-Onc - Director, Executive , Thousand Oaks, California

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