Program Lead – Clinical Delivery

Overview

PE Global are currently recruiting for a Program Lead – Clinical Delivery for a contract role with a leading multinational Pharma client, based in Bracknell. The purpose of the Clinical Delivery Program Lead is to lead the creation and execution of the exploratory and biopharmaceutics clinical development plans at a molecule level, with technical leadership and operational oversight of clinical research trials within the development plan.

The Clinical Delivery Program Lead is responsible for planning and delivering exploratory and biopharmaceutics clinical molecules and submissions milestones on time and on budget throughout the molecule lifecycle, and is responsible for all aspects of global clinical trial operations within the plan as the single operational point of contact from trial design through execution and close out, including timeline creation and management, outsourcing plan, vendor management (including direct oversight of the operational deliverables), patient recruitment and retention and budget management.

• Lead the development of the clinical asset strategy for phase 1 leveraging quality decision making principles.
• Understand assigned therapeutic area including trial designs, risks and execution challenges and best practices.
• Provide consultation to the project team for clinical and regulatory documents such as study protocols, Investigator Brochures (IBs), risk profiles, annual reports, briefing documents, New Drug Applications (NDAs), safety updates, clinical study reports (CSRs), abstracts, publications, and manuscripts.
• Stay up to date with current body of knowledge of relevant disease states/targets, competitors, and industry trends and best practices.
• Maintain knowledge of operational requirements to effectively plan exploratory and biopharmaceutics clinical development studies and submissions (e.g., First Human Dose requirements) and the detail of operations to deliver critical path studies and submissions.
• Lead and have expertise in the implementation and integration of clinical project management processes and tools.
• Work with Third Party Organizations (TPOs) to execute the defined clinical strategy, overseeing key trial deliverables.
• Develop and maintain up-to-date clinical plan timelines and process maps (if appropriate) ensuring communication of progress to the broader molecule team.
• Partner with the financial organization, cross-functional partners, and geographies to develop and manage the overall clinical budget for the molecule level book of work including initiation and management of the change process.
• Proactively identify and communicate clinical risk assessment and mitigation/contingency plans within team and to functions, affiliates, and leadership.
• Accountable and responsible for oversight of clinical trial operations and delivery of clinical project milestones on time, on budget.
• Create and manage implementation timeline and clinical trial activities.
• Involved in selection process and management of vendors, providing day to day oversight for operational deliverables with external network of vendors to ensure on time and on budget clinical project deliverables.
• Serve as the point of contact for the global clinical team, to resolve clinical implementation issues (internal and external), lead risk assessments and contingency planning, and effective communication across and upward.
• Partner with regulatory and medical to ensure safety management and monitoring processes are implemented.
• Influence and work with a quality mindset across the clinical team by documenting key decisions, actions and key modifications in clinical scope, resources, and timeline; ensuring accurate collection and communication of clinical metrics; ensuring archival of all relevant clinical information at the termination of a project and as appropriate throughout the project.
• Manage key partnerships and interactions/integration with the clinical team, including leadership in governance forums (if applicable).
• Effectively and reliably communicate and influence at all levels across the organization to enable decision-making by team and governance/Stakeholders.
• Collaborate…