Sr Manager IVD Strategy Operations - Precision Medicine Unit

Career Category

Job Description

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 awardwinning 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.

Sr. Manager IVD Strategy & Operations Precision Medicine Unit

What you will do

Lets do this. Lets 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 crossfunctional 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 crossfunctional forums and processes in charge of driving holistic decisions and alignment regarding Amgens position and strategy to align with global IVD regulations including IVDR in EU new LDT regulations in US etc. Additionally you will partner with crossfunctional stakeholders to ensure training maintenance discuss facilitation and workshops and ensure performance tracking and change management.

Responsibilities:

• CrossFunctional 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 crossfunctional discussions ensuring clear agendas actionable outcomes and followup on key decisions related to IVD pullthrough 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 crossfunctional perspectives into cohesive IVD strategies raising critical issues to the Leadership team/Steering Committee as needed
• ProgramLevel Subject Matter Expert (SME) Support: Support programfacing 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 : Implement and maintain standardized workflows trackers and templates to streamline crossfunctional activities and enhance efficiency in regulatory tracking and reporting
• Performance Tracking: Monitor and report on the progress of crossfunctional activities training completion rates and SharePoint usage providing regular updates to the Director to support strategic decisionmaking
• Continuous Improvement & Change Management.: Find opportunities to enhance coordination processes training effectiveness and knowledgesharing 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

Masters degree and 7 years of directly related industry experience

OR

Bachelors degree and 9 years of directly related industry experience

Preferred Qualifications:

• Bachelors 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&Drelated roles regulatory affairs project management or crossfunctional 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
• Detailoriented with a proactive approach to problemsolving 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 wellbeing. 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 salesbased incentive plan
• Stockbased longterm incentives
• Awardwinning timeoff 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.

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