Antonio Llamas Villar

Key Responsibilities:

- Evaluate and optimize processes to improve the efficiency and quality of Clinical Trial Management.

- Lead initiatives in Decentralized Clinical Trials (DCT) and Risk-Based Quality Management (RBQM), anticipating new regulations and integrating emerging technologies to enhance study execution.

- Ensure inspection readiness and maintain compliance with global regulatory requirements. lead Inspection response team.

- Lead and coordinate the training team, promoting knowledge sharing and continuous professional development.

- Contribute to business development activities, fostering strategic partnerships and supporting organizational growth.

• Country Head coordinating all spanish specific activities such as Inspection readiness. Emergency and contingency Plans, Profarma Plan, oversight of Clinical Trials Agreements (CTAs) as well as financial aspects of the development studies in close collaboration with Finance, Regulatory and Medical Affairs among other departments and functions

• Managing operational activities of Post-Authorization (PAS), Collaboratives studies and ISRs.

• Supporting the operational activities of other clinical development studies, including support to feasibilities, recruitment or relationship issues, logistics, IPD decision tree, audits and inspections, as delegated by study teams

• ClinOps Late Phase Therapeutic Area Liaison (oncology, Fungal diseases), between Medical Affairs and Clinical Operations for the conduct and oversight of ISRs and CO worldwide (From Sep 2019 to Jun 2024).

• Management of Clinical Operations in Spain, being responsible for feasibility process, relationships with KOL and CRO partners, quality control and oversight, as well as direct support to Medical Affairs team