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 Experts from all Global Drug Development line functions (e.g. CD, Global Clinical Operations, Regulatory Affairs, and Quality Assurance) to drive GDD inspection readiness. Ensures a well-managed, effective and engaged Subject Matter Expert team. Improves processes based on performance metrics, identification of cross-functional issues/gaps and corrective actions utilizing new technologies and insights. Authors and maintains appropriate Standard Operating Procedures, Working Practices, Guidance Documents, and Clinical Document Templates (e.g. Clinical Trial Protocol, Clinical Development Plan, Concept Sheet, Investigator Brochure, and Clinical Data Review) in alignment with other process SMEs/owner. Drives best practices by identifying training needs, developing and conducting training for GPTs/GCTs/CTTs on the processes, guiding them in day-to-day activities, helping to prepare teams for inspections and audit. Leads/drives and implements important strategic projects across Development Units and Global Line Functions as defined by CD Leadership Team. Lead QA/SOP activities within CD, which includes coordinating Subject Matter Experts (SME) identification; applying clinical applicability; performing collegial reviews of SOPs, templates and processes. Work with the Clinical Science organization to ensure that CD Leadership is informed at all points about key issues and has access to information when needed. Deputizes for the Head CD Business Solutions and Head Clinical Compliance & Processes, where needed.

Requirements Advanced degree in life sciences/ healthcare (or clinically relevant degree) is required. Master, PharmD, or PhD strongly preferred. Strong understanding of Pharmaceutical Development processes. ≥10 years technical and operational experience in planning, executing, reporting and publishing clinical studies in industry or Academia. Expert knowledge of Good Clinical Practice, regulations, and quality management systems. Experienced in understanding and designing effective and efficient end-to-end processes. Action orientated mindset: make things happen - exhibit a strong will to drive change. Strong skills in leading and managing cross-functional projects/teams with business impact Proven ability to lead, coach and creating a positive work environment by being a role model of our values and behavior. Demonstrated courage to assume personal accountability in challenging situations. Ability to work independently without much direction and guidance. Strong leadership presence with ability to present and interact with executives and senior boards. Ability to influence without authority and navigate through organizational complexity, dynamics, and opposing needs while gaining trust at all levels of the organization. Strong interpersonal, communication (written and verbal) and negotiation skills. Act as change agent and actively generate and foster creativity and innovation in CD.

Interested candidates should submit an updated CV.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***