IRT Operations Manager - Biogen

The Global Clinical Supply Chain group is looking to expand and hire an Operations Manager to serve as the SME and operations lead in the IRT space. This person will be managing the day-to-day performance of Biogen’s IRT system vendors and the outsourced operations. In addition, this role will directly own and operate individual trial management systems. The role also includes leading quality management for IRT including issue resolution and continuous improvement, defining and implement IRT and vendor metrics that will drive team performance and provide actionable insight for PO&T and R&D, as well as acting as Business Process Owner (BPO).

This is a hybrid role that will be based at our headquarters in Cambridge, MA.

What You’ll Do

• IRT System and Process Owner:
  • Day-to-day operational management of IRT (IXRS, RTSM) system providers including integrations from acquisitions.
  • Collaborates with key process partners in the sourcing, evaluation as well as audit/qualification of IRT systems
  • Partners with IRT Lead on defining IRT vendor strategy and conducting quarterly Business Review Meetings.
  • Owns process and procedure management for IRT, as well as training curriculum and execution. Collaborates with internal and external functions to ensure Biogen practices and processes are being adhered to.
  • Owns and executes all Quality and documentation workflows related to IRT within Biogen systems.
• IRT Senior Contributor
  • Maintains admin level access and working knowledge for all Biogen IRT systems to remain up to date with system performance across standards and vendor platforms.
  • Manages system lifecycle and maintains Biogen IRT standards and their adoption.
• IRT Metrics Leads
  • Defines, implements and maintains IRT operations metrics that provide actionable insights for IRT and broader GCSC management.
  • Analyzes and improves supplier metrics to assess relationship health and highlight quality risks.
• IRT FSP Outsourced Servies Engagement
  • Day-to-day operational management of the outsourced service including task prioritization, team performance and issue resolution.
  • Partners with IRT Lead on outsourced service budgeting, accounting and resource planning and quarterly business reviews.
• CI Initiatives Leadership
  • Leads continuous improvement activities to create additional value from IRT.
  • Maintains connection to IRT industry and brings in industry best practice opportunities.

• Bachelor’s degree in science or related technical area and at least 7 years of related experience.
• Demonstrated knowledge of IRT operations, from theory to practice and from end-to-end process view to tactical system activities
• Demonstrated experience in IRT system definition and IRT vendor management
• Experience working in Quality systems for issue and documentation management.
• Understanding of metrics and data concepts and application to the GCSC business environment.
• Working knowledge of contract manufacturing and distribution operations in the Pharmaceutical or Biotechnology industry
• Working knowledge and exposure to GMP and GDP.
• Strong sense of customer service with high level of self-motivation.
• Strong communication skills and sense of accountability
• Experience working within a matrix organization in alignment with key stakeholders.

Who You Are

You are an IRT expert with management aspirations who can draw from past experiences to develop solutions to complex problems that require a moderate degree of ingenuity, creativity, and innovativeness. You should be able to work in a highly-matrixed organization to influence and provide the voice of GCSC and PO&T to GCO stakeholders.

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.