Director Clinical Development
New Yesterday
OverviewPE 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.RoleDirector Clinical Processes & Solutions – The Director is accountable for the end-to-end CD processes, related Standard Operating Procedures, in alignment with regulations, and will lead a cross-functional/cross-divisional network of Subject Matter Experts to continuously drive process improvement and inspection readiness on behalf of Global Drug Development.ResponsibilitiesDrives 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 comply with regulatory requirements and that inspection findings are adequately addressed.In collaboration with QA, implement quality initiatives as needed: inspection readiness, records tracking, support audits preparation and follow up. Present applicable CD processes to Health Authority inspectors and auditors.Establishes and maintains a multi-disciplinary network of Subject Matter Experts from all Global Drug Development line functions to drive inspection readiness and ensure an engaged expert team.Improves processes based on performance metrics, cross-functional issues/gaps, and corrective actions using new technologies and insights.Authors and maintains SOPs, 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 process owners.Identifies training needs, develops and conducts training for GPTs/GCTs/CTTs on processes, guides day-to-day activities, and helps prepare teams for inspections and audits.Leads strategic projects across Development Units and Global Line Functions as defined by the CD Leadership Team.Leads QA/SOP activities within CD, coordinating SME identification, applying clinical applicability, and performing collegial reviews of SOPs, templates and processes.Works with the Clinical Science organization to ensure CD Leadership is informed and has access to key information when needed.Deputizes for the Head CD Business Solutions and Head Clinical Compliance & Processes as required.RequirementsAdvanced 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.Experience in designing effective and efficient end-to-end processes.Action-oriented mindset with a proven ability to drive change.Strong skills in leading and managing cross-functional projects/teams with business impact.Proven ability to lead, coach, and create a positive work environment; model company values and behavior.Ability to work independently with minimal direction; strong leadership presence for interacting with executives and senior boards.Ability to influence without authority and navigate organizational complexity while gaining trust at all levels.Strong interpersonal, written and verbal communication and negotiation skills.Act as a change agent, fostering creativity and innovation in CD.Visa note: Please note our client cannot assist with visa sponsorship and candidates must have the correct visa to live and work in the UK.Seniority levelDirectorEmployment typeContractJob functionOtherIndustriesPharmaceutical Manufacturing and Biotechnology Research
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- Location:
- England, United Kingdom
- Job Type:
- FullTime