Senior Principal Scientist - Global Diagnostic Development Lead
Description:
Job Details
Join Amgens Mission of Serving Patients
At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Senior Principal Scientist - Global Diagnostic Development Lead
What you will do
Lets do this. Lets change the world. In this vital role you will be responsible for the development and implementation of Diagnostic (Dx) development strategies globally.
Integral to the ongoing success of Amgens growing pipeline, the Diagnostics (Dx) Group is responsible for the successful transition of a biomarker assay to marketed Diagnostic to support the clinical development strategy for regulatory approval and commercialization.
As such, the Dx 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 developing life cycle management plans that align to the needs of their corresponding precision therapeutics programs. The Diagnostic Development Lead role at Amgen requires a breadth of technical expertise across a broad range of in-vitro diagnostic technologies, influencing decision-making through negotiation, and addressing conflict by building productive working relationships across functional areas both within and outside the company.
This position will report to a Global Diagnostics Strategy Director and be responsible for the successful implementation of the CDx strategy across multiple therapeutic areas with a focus on oncology.
Responsibilities:
Execute endtoend global diagnostic development strategies to support therapeutic product teams, including regulatory approval, commercialization, and diagnostic lifecycle plans
Lead efforts to oversee assay development and assay transfer to CROs with diagnostic partners
Support diagnostic development options, technologies, and diagnostic market landscape assessment
Work with key cross-functional partners to implement diagnostic development, approval and launch strategies for the product teams together with third-party diagnostic partners and ensure successful implementation of the overall Dx strategy globallyWhat we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of pharmaceutical and/or diagnostics experience
Or
Masters degree and 4 years of pharmaceutical and/or diagnostics experience
Or
Bachelors degree and 6 years of pharmaceutical and/or diagnostics experience
Or
Associates degree and 10 years of pharmaceutical and/or diagnostics experience
Or
High school diploma / GED and 12 years of pharmaceutical and/or diagnostics experience
Preferred Qualifications:
Effective presentation and communication skills at the senior/executive management level
Experience in oncology precision medicine development and / or in vitro diagnostics development
Experience in companion diagnostics development and knowledge of regulatory submission requirements of in vitro diagnostic devices in multiple markets preferred
Knowledge and experience in clinical trial design preferred
Experience integrating data from multiple sources and identifying critical process variables
Experience establishing and reviewing complex plans for multiple projects or activities. This includes resource allocation, complex timeline development, risk identification and mitigation
Experience in digital pathology is a plusWhat you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.
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.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:
A 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
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
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, disability status, or any other basis protected by applicable law.
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.
Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world's leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together-to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we're transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
Company info
Website Phone Location Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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