Let’s get started
By clicking ‘Next’, I agree to the Terms of Service
and Privacy Policy, and consent to receive emails from Rise
Jobs / Job page
Director IVD Strategy & Operations - Precision Medicine Unit image - Rise Careers
Job details

Director IVD Strategy & Operations - Precision Medicine Unit

Career Category

Scientific

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Director 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 PMED Head of Strategy & Ops. and Head of 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 lead and steward of a cross-functional team in charge of driving cross-functional 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 senior leaders and teams across Research & Development oversee integration of frameworks, processes, and documents across Amgen for all CDx-related Functions impacted by new regulations.

Responsibilities:

  • Develop cross-functional RACI on strategy and implementation of IVD results and lead cross-functional forum to drive consensus and decisions across the enterprise
  • Conduct frequent gap assessments to ongoing and new CDx studies and ensure coordinated cross-functional implementation and pull-through of new IVD regulations
  • Drive the development of and end-end process/playbook to conduct combined drug and device trials
  • Conduct gap assessments of current risks/mitigations on products impacted by existing and upcoming regulations
  • Establish and lead a cross-functional IVD committee to develop Amgen’s position and strategy to align with global IVD regulations
  • Identify and address key organizational, procedural and training gaps to implement IVDR and other Regulatory requirements
  • Establish and maintain a robust system for tracking regulatory changes, guidance documents, and industry trends in the CDx space, ensuring timely identification of risks and opportunities
  • Ensure PTs/EGTs, sub-teams and functions are trained for future submissions and materials are embedded into CMZ and PMed docs such as Portal guidelines, PMed Portal guidelines, etc.
  • Ensure decisions by the IVD cross-functional team is communicated to individual asset teams

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:

  • Advanced degree (e.g., MS, PhD, JD) in life sciences, regulatory affairs, or a related field
  • 10+ years of experience in biopharma, with a focus on clinical operations, development or regulatory affairs, preferably in the diagnostics or CDx space
  • Deep understanding of IVDR, LDT regulations, FDA policies, and global CDx regulatory frameworks
  • Deep understanding of the R&D (preferred clinical operations), drug development and commercialization process
  • Proven leadership experience in building and managing cross-functional teams
  • Strong analytical skills with the ability to assess complex regulatory data and distill actionable strategies
  • Excellent communication and influencing skills, with experience engaging senior stakeholders and external regulators. Executive presence by which one can quickly establish credibility with and influence VP/EVP level staff
  • Ability to thrive in a fast-paced, dynamic environment with shifting priorities
  • Leadership experience in building and developing high performing teams, delivering results and shaping the future
  • Project management / Operations experience within a biotech, pharmaceutical or CRO company
  • Finance and budget management experience
  • Exceptional leadership and team 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.

careers.amgen.com

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.

.

Salary Range

181,245.00 USD - 214,524.00 USD
Amgen Glassdoor Company Review
4.2 Glassdoor star iconGlassdoor star iconGlassdoor star iconGlassdoor star icon Glassdoor star icon
Amgen DE&I Review
No rating Glassdoor star iconGlassdoor star iconGlassdoor star iconGlassdoor star iconGlassdoor star icon
CEO of Amgen
Amgen CEO photo
Robert A. Bradway
Approve of CEO

Average salary estimate

$197884.5 / YEARLY (est.)
min
max
$181245K
$214524K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

Similar Jobs
Photo of the Rise User

Join Amgen as a Specialty Account Manager in Endocrinology and play a critical role in driving sales and managing key accounts within the healthcare sector.

Photo of the Rise User

Join Amgen in making a lasting impact on patient lives as a Specialty Account Manager focusing on Rare Diseases.

Loma Linda Hybrid Murrieta, California, United States
Posted 10 days ago

Join Loma Linda University Medical Center's Graduate Nurse Residency Program to kickstart your career in nursing with unparalleled support and professional development.

Photo of the Rise User
Posted 11 days ago

Join LifeStance Health in South Portland as a Clinical Psychologist and contribute to a healthier society through unified mental healthcare.

Photo of the Rise User

Join a leading Urgent Care provider as a Radiological Technologist, delivering quality patient care in a dynamic environment.

Photo of the Rise User
Posted 14 days ago

Join Vestcom, a leader in retail shelf-edge solutions, as a Laser Print Operator and be part of a dynamic and fast-paced team.

Photo of the Rise User
Carle Health Hybrid US, Champaign County, IL; Illinois, Urbana, IL
Posted 13 days ago

Join Carle Health as an Ambulatory Nurse where you can make a meaningful impact in patient care and enjoy a supportive team environment.

Photo of the Rise User
Westgate Resorts Hybrid 750 Emerald Pointe Drive, Hollister, Missouri, United States
Posted 10 days ago

As a member of the Westgate Branson Lakes team, the Resort Facilities Maintenance Technician 3 plays a pivotal role in maintaining high standards of resort facilities.

Photo of the Rise User

As a Security Guard with Allied Universal®, you will safeguard clients across various industries in a part-time role offering dynamic workplace experiences.

Posted 13 days ago

Join Over the Top Tents & Events as a Tents & Events Technician, where you'll help create memorable experiences at various events throughout Alaska.

Photo of the Rise User
Datadog Hybrid Tallahassee, FL
Posted 10 days ago
Customer-Centric
Rapid Growth
Diversity of Opinions
Reward & Recognition
Friends Outside of Work
Inclusive & Diverse
Empathetic
Feedback Forward
Work/Life Harmony
Casual Dress Code
Startup Mindset
Collaboration over Competition
Fast-Paced
Growth & Learning
Open Door Policy
Rise from Within
Maternity Leave
Paternity Leave
Flex-Friendly
Family Coverage (Insurance)
Medical Insurance
Dental Insurance
Vision Insurance
Mental Health Resources
Life insurance
Disability Insurance
Health Savings Account (HSA)
Flexible Spending Account (FSA)
401K Matching
Paid Holidays
Paid Sick Days
Paid Time-Off

Join Scott Quality Electric Inc. as an Inventory Assistant and play a key role in ensuring our operations run smoothly while enjoying a supportive workplace.

Photo of the Rise User

The RN Clinical Nurse will serve as a vital member of the patient services team, ensuring exceptional patient care at Spalding Medical Center.

Join Virginia Mason Franciscan Health as a Surgery Certified Coding Specialist, focusing on coding multi-specialty surgery cases in a fully remote role.

Photo of the Rise User
Posted 24 hours ago

Lead day-to-day operations of a vibrant multifamily housing community while overseeing a dedicated team in Richland, WA.

Photo of the Rise User
Greenlife Healthcare Staffing Hybrid No location specified
Posted 13 days ago

Deliver comprehensive dental care and improve oral health for underserved populations as a Dentist at a state-operated hospital in Indiana.

To serve patients. Amgen strives to serve patients by transforming the promise of science and biotechnology into therapies that have the power to restore health or save lives. In everything we do, we aim to fulfill our mission to serve patients....

230 jobs
MATCH
Calculating your matching score...
FUNDING
DEPARTMENTS
SENIORITY LEVEL REQUIREMENT
TEAM SIZE
EMPLOYMENT TYPE
Full-time, remote
DATE POSTED
April 7, 2025

Subscribe to Rise newsletter

Risa star 🔮 Hi, I'm Risa! Your AI
Career Copilot
Want to see a list of jobs tailored to
you, just ask me below!
LATEST ACTIVITY
Photo of the Rise User
Someone from OH, Cleveland just viewed Sales Associate (Sur La Table) at CSC Generation
Photo of the Rise User
Someone from OH, Columbus just viewed Resident Assistant (RA) at Datadog
Photo of the Rise User
Someone from OH, Cleveland just viewed Bellman and Doorman at Marriott International
Photo of the Rise User
13 people applied to Executive Assistant at Billtrust
Photo of the Rise User
Someone from OH, Cincinnati just viewed Finance Intern at Roche
Photo of the Rise User
Someone from OH, Cincinnati just viewed Personal Shopper - Sam's at Walmart
F
Someone from OH, Cincinnati just viewed CART - Captionist at Focus Interpreting
P
Someone from OH, Brecksville just viewed Verification Specialist at Planned Parenthood of Illinois
Photo of the Rise User
Someone from OH, Sheffield Lake just viewed Busser/Server Assistant at Chili's Grill and Bar
Photo of the Rise User
Someone from OH, Cincinnati just viewed Furniture Sales Representative at Furniture Fair
Photo of the Rise User
100+ people applied to US Pharmacist at Remote VA
Photo of the Rise User
Someone from OH, Dayton just viewed Data Engineer | NDA at GT
Photo of the Rise User
Someone from OH, Dayton just viewed Data Engineer at Koddi
Photo of the Rise User
Someone from OH, Dayton just viewed Data Engineer at Launchpad Technologies
Photo of the Rise User
Someone from OH, Columbus just viewed Accounts Receivable Specialist at Brixio