Sr. Manager IVD Strategy & Operations - Precision Medicine Unit

em, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Sr. Manager IVD Strategy & Operations - Precision Medicine Unit

What you will do

Let's do this. Let's change the world. In this vital role you will work closely with the Invitro Diagnostics/ Diagnostic (IVD/Dx) Strategy & Ops. Director, Precision Medicine Head of Strategy & Operations and Head of Companion Diagnostics (CDx), as well as a number of cross-functional Dx stakeholders (Regulatory, Quality, Safety, Medical, Commercial, etc.) to advance the development and delivery of IVD/Dx strategies. You will serve as the steward of cross-functional forums and processes in charge of driving holistic decisions and alignment regarding Amgen's position and strategy to align with global IVD regulations including IVDR in EU, new LDT regulations in US, etc. Additionally, you will partner with cross-functional stakeholders to ensure training maintenance, discuss facilitation and workshops, and ensure performance tracking and change management.

Responsibilities:

• Cross-Functional Coordination: Facilitate collaboration across teams (e.g., Reg, R&D, clinical, quality, Medical, Commercial, etc.) by organizing and leading forums, meetings, and working groups to align on IVD regulatory objectives

• Forum Management: Plan, implement, and document cross-functional discussions, ensuring clear agendas, actionable outcomes, and follow-up on key decisions related to IVD pull-through at the program level (incl. Annual Dx Summit and others)

• Training Maintenance: Develop, update, and maintain training materials and programs to educate internal stakeholders on IVD regulatory requirements (e.g., IVDR, LDT), ensuring content is current, accessible, and tailored to team needs (incl. SharePoint, Knowledge Management, etc.)

• Discussion Facilitation: Drive productive conversations to integrate cross-functional perspectives into cohesive IVD strategies, raising critical issues to the Leadership team/Steering Committee as needed

• Program-Level Subject Matter Expert (SME) Support: Support program-facing SMEs w/ the translation of IVD Reg. insights into actionable plans for specific CDx programs, ensuring alignment with broader company goals and compliance requirements (incl. facilitating workshops when needed)

• Process Execution: Implement and maintain standardized workflows, trackers, and templates to streamline cross-functional activities and enhance efficiency in regulatory tracking and reporting

• Performance Tracking: Monitor and report on the progress of cross-functional activities, training completion rates, and SharePoint usage, providing regular updates to the Director to support strategic decision-making

• Continuous Improvement & Change Management.: Find opportunities to enhance coordination processes, training effectiveness, and knowledge-sharing systems, proposing solutions to optimize performance

What 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 4 years of directly related industry experience

OR

Master's degree and 7 years of directly related industry experience

OR

Bachelor's degree and 9 years of directly related industry experience

Preferred Qualifications:

• Bachelor's degree in life sciences, regulatory affairs, or a related field (advanced degree preferred)

• 7+ years of experience in biopharma, with a focus on clinical operations, R&D-related roles, regulatory affairs, project management, or cross-functional coordination, ideally with direct involvement within diagnostics or CDx

• Familiarity with CMZ, R&D and IVD regulations (e.g., IVDR, LDT) and their application to product development and commercialization

• Strong organizational and facilitation skills, with a proven ability to manage multiple stakeholders and priorities

• Proficiency with collaboration tools (e.g., SharePoint, Microsoft Teams) and experience maintaining knowledge repositories

• Excellent communication skills, with the ability to bridge technical and operational perspectives for diverse audiences

• Detail-oriented with a proactive approach to problem-solving and process improvement

• Exceptional communication and change management skills

What 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, we'll 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

• Flexible work models, including remote and hybrid work arrangements, where possible

Apply now and make a lasting impact with the Amgen team.
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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.

Salary Range
141,928.00 USD - 171,979.00 USD