Director Clinical Development

Job Description

PE Global is currently recruiting for a Director Clinical Processes & Solutions for an 18 month contract role with a leading multinational Pharma client based in London.

The Director Clinical Processes & Solutions, in close collaboration with Process, Risk & Surveillance (PRS), is accountable for the CD end-to-end processes, related Standard Operating Procedures, in alignment with regulations, and leading a cross-functional / cross-divisional network of Subject Matter Experts to continuously drive process improvement and inspection readiness on behalf of Global Drug Development.

Job Responsibilities

• Drives cross-CD and Global Line Function alignment of processes, including implementation across Development Units, to ensure high-quality processes and limited inspection findings.
• In partnership with Development, CD, PRS, Global Clinical Operations, Regulatory Affairs, and Quality Assurance, ensures processes are in line with regulatory requirements and inspection findings adequately addressed.
• In collaboration with QA, responsible to implement quality initiatives as needed : inspection readiness, records tracking, support audits preparation and follow up. Presents applicable CD processes to Health Authority inspectors and auditors.

Establishes and maintains a multi-disciplinary network composed of Subject Matter E...