Overview

Director, Clinical Processes & Solutions

Job Type: Temporary | Location: London/Remote | Contract Length: 6 months | Rate: circa £600 per day

SRG are collaborating with a global Pharmaceutical Company who have a new opening for a Director, Clinical Processes & 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 & 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 departments.
• 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.
• 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 Templates.
• Leading & implementing important strategic projects across Development Units and Global Line Functions as defined by the Leadership Team.

Qualifications

• Advanced degree in life sciences/ healthcare (or clinically relevant degree) is required. Master, PharmD, or PhD strongly preferred
• Strong understanding of Pharmaceutical Development processes
• Over 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
• 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

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