Director IVD Strategy & Operations

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.

Director 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 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 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 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 Amgens 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

Masters degree and 7 years of directly related industry experience

OR

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

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

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.