Director Clinical Processes & Solutions

Overview

Director, Clinical Processes and SolutionsJob Type: TemporaryLocation: London/RemoteContract Length: 6 monthsRate: circa. 600 per daySRG are collaborating with a global Pharmaceutical Company who have a new opening for a

Director, Clinical Processes and Solutions

or to support the team for an initial 6 month contract. This role will be accountable for the Clinical Development 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. The successful candidate will have ample planning and executing clinical trials, as well as leading cross-functional teams.Responsibilities

Driving Clinical Development and Global Line Function alignment of processes, including implementation across Development Units, to ensure high-quality processes and limited inspection findings.Ensuring processes are in line with regulatory requirements and inspection findings adequately addressed, in partnership with other key departmentsIn 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.Establishing and maintaining a multi-disciplinary network composed of Subject Matter Experts from all Global Drug Development line functions (e.g. Global Clinical Operations, Regulatory Affairs, and Quality Assurance) to drive GDD inspection readiness. Ensures a well-managed, effective and engaged Subject Matter Expert team.Improving processes based on performance metrics, identification of cross-functional issues/gaps and corrective actions utilizing new technologies and insights.Authoring and maintaining appropriate Standard Operating Procedures, Working Practices, Guidance Documents, and Clinical Document TemplatesLeading and implementing important strategic projects across Development Units and Global Line Functions as defined by the Leadership TeamQualifications

Advanced degree in life sciences/ healthcare (or clinically relevant degree) is required. Master, PharmD, or PhD strongly preferredStrong understanding of Pharmaceutical Development processesOver 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 systemsExperienced in understanding and designing effective and efficient end-to-end processesAction orientated mindset: make things happen - exhibit a strong will to drive changeStrong skills in leading and managing cross-functional projects/teams with business impactDemonstrated courage to assume personal accountability in challenging situationsAbility to work independently without much direction and guidanceStrong leadership presence with ability to present and interact with executives and senior boardsAbility to influence without authority and navigate through organizational complexity, dynamics, and opposing needs while gaining trust at all levels of the organizationTo Apply

If you want to find out more about this role or would like to make an application, please click to apply and/or email me to discuss in more detail.Carbon60, Lorien and SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this ..... full job details .....