Associate Director, Clinical Affairs

At Veracyte, we offer exciting career opportunities for those interested in joining a pioneering team that is committed to transforming cancer care for patients across the globe. Working at Veracyte enables our employees to not only make a meaningful impact on the lives of patients, but to also learn and grow within a purpose driven environment. This is what we call the Veracyte way its about how we work together, guided by our values, to give clinicians the insights they need to help patients make life-changing decisions.

Our Values:

• We Seek A Better Way
  :
  We innovate boldly, learn from our setbacks, and are resilient in our pursuit to transform cancer care
• We Make It Happen
  :
  We act with urgency, commit to quality, and bring fun to our hard work
• We Are Stronger Together
  :
  
  We collaborate openly, seek to understand, and celebrate our wins
• We Care Deeply
  :
  We embrace our differences, do the right thing, and encourage each other

The Associate Director, Clinical Affairs (Europe) oversees the full lifecycle of clinical studies, ensuring compliance with European regulations and standards. This includes protocol development, implementation, closeout, and reporting. The role manages study documentation, trains staff, monitors progress, ensures protocol and regulatory compliance, and oversees budgets, timelines, and vendor relationships. The position also maintains study metrics, contributes to scientific publications and regulatory submissions, and serves as the clinical affairs representative on cross‑functional teams.

About 25% travel will be required for this role, most travel will take place in Europe. This individual may need to be available for occasional meetings that take place virtually in the United States.
We are in search of a candidate based in Norway; however, we are open to considering candidates based in Central and Western Europe.

• Regulatory Compliance
  • Ensure all clinical studies are conducted in accordance with EU Clinical Trials Regulation (EU CTR No. 536/2014), ICH-GCP, ISO 20916, Veracyte SOPs, and relevant national requirements.
  • Oversee submissions to Ethics Committees (ECs) and Competent Authorities via the Clinical Trials Information System (CTIS).
  • Maintain compliance with GDPR for data protection and patient privacy.
  • Ensure adherence to In Vitro Diagnostic Regulation (IVDR, EU 2017/746) for relevant studies.
• Study Management
  • Lead planning, execution, and oversight of clinical studies, ensuring delivery on time, within budget, and in compliance with European and global standards.
  • Develop essential study documents (protocols, informed consent forms, case report forms, training manuals, monitoring plans, SOPs).
  • Coordinate selection and oversight of CROs, vendors, clinical sites, and investigators across Europe.
  • Facilitate IRB/EC submissions and ensure regulatory compliance throughout the study lifecycle.
  • Manage study conduct, including site training, communications, initiation, monitoring, and close‑out visits.
  • Maintain Trial Master Files (TMFs) and ensure documentation integrity.
• Cross‑Functional Collaboration
  • Collaborate with Medical Affairs, Product Development, Managed Care, Commercial, Regulatory Affairs, and Market Access teams to implement clinical development strategies aligned with product goals.
  • Build and maintain scientific relationships with key investigators, institutions, and consortia in Europe.
  • Communicate evolving priorities and study updates across clinical and cross‑functional teams.
  • Flexibility of work hours to accommodate collaboration with US‑based colleagues.
• Data Quality & Reporting
  • Review and support execution of data management and statistical analysis plans.
  • Ensure data quality through monitoring plans, data reviews, and process control checks.
  • Oversee adverse event reporting in accordance with European regulatory and SOP requirements.
  • Contribute to process improvements and stay informed on trends in clinical study design and execution.
• Leadership & Mentoring
  • Mentor and oversee clinical research staff as needed.
  • Develop and manage detailed project plans and provide regular study status updates.

• Education & Experience
  • A minimum of 8 years of…