Clinical Operations Excellence Lead

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. 

The Clinical Operations Excellence Lead (COEL) is responsible for the operational implementation of the clinical QMS in a consistent, effective and efficient way within the Global Clinical Operations organization (Global Trial Operations, Data Management, Medical Writing and Global Sourcing & Alliance Management), in accordance with the global quality strategy. The successful candidate will excel in leadership and establishing good and effective internal and external working relationships and communication.

Roles and Responsibilities:

• Ensure oversight of the adequacy of processes in Global Clinical Operations. Ensure regulatory requirements and commitments are reflected in the procedural documents

• Identify and drive continuous improvement of processes and systems within Global Clinical Operations organization

• Ensure quality risk management principles are integrated in all Global Clinical Operations processes and systems in order to support compliance and ensure inspection readiness throughout

• Drive the investigations and development of CAPA plans related to process-level non-compliances, audit and inspection findings, within the Global Clinical Operations organization

• Actively contribute to a feedback culture on non-compliance, CAPA, inspection and audit findings. Identify opportunities to share knowledge and expertise

• Actively participate in defining and monitoring compliance and quality metrics to ensure compliance oversight in Global Clinical Operations processes and projects

• Ensure proper focus and prioritization of clinical process improvement activities by consistently applying Quality Risk Management and Quality-by-Design principles 

• Identify and implement leading edge technologies and methodologies to enable quality by design of clinical study activities

• Active member of the Global Clinical Operations leadership team to ensure alignment across functions and regular review of the inspection readiness status

• Lead and/or contribute to cross-functional and/or cross-company initiatives aiming to increase quality and compliance, while decreasing rework

• Ensure alignment with the QA organization

• Act as interface between Global Clinical Operations and stakeholder organizations/functions in clinical development

• Foster co-creative working relations with partnering organizations such as QA, BIS, Clinical Development, GPS, GRA

Skills and Competencies:

• Extensive experience of GCP/Pharmacovigilance quality management systems, applicable regulatory rules and guidelines, medical terminology, clinical trials, and drug development

• Excellent interpersonal negotiation and leadership skills

• Strong written and verbal communication skills, acting globally in a culturally-diverse dynamic team

• Ability to act independently and effectively prioritize

• Root Cause Analysis, CAPA Development and Risk Management methodology expertise

Education, Experience and Qualifications:

• Bachelor’s degree or University degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience

• Minimum of 10 years of experience in Clinical and/or Pharmacovigilance Quality Management

• Working knowledge of the relationship and regulatory obligations of pharmaceutical/biotech companies and CROs

• Global Strategic Drug Development experience

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