Director IVD Strategy & Operations - Precision Medicine Unit

Career Category

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 an