Program Lead – Clinical Delivery

PE Global (UK); Massachusetts; On-site; USD 120,482 - 160,642; Full time

Job summary

PE Global is seeking a Program Lead – Clinical Delivery for a contract role in Bracknell. The role focuses on leading exploratory and biopharmaceutics clinical development plans, with operational oversight of trials from design through closeout, including timelines, outsourcing, vendor management, recruitment and budget control.

The successful candidate will guide global trial operations, collaborate with regulatory and medical teams, manage risk, and drive milestones on time and on budget in a

Qualifications

• Bachelor’s degree in a science-related field from an accredited college or university.
• 3 years’ experience in the pharmaceutical industry with direct experience of managing clinical studies.
• Strong knowledge of regulations and guidelines for clinical trials.
• Ability to influence and oversee TPOs to deliver trial deliverables.
• Demonstrated project management skills and cross-cultural collaboration.

Responsibilities

• Lead the development of the clinical asset strategy for phase 1 leveraging quality decision making.
• Oversee trial design, risk and execution challenges and best practices across trials.
• Provide consultation on study protocols, IBs, NDAs, CSRs, safety updates and reports.
• Coordinate with TPOs to ensure timely, on-budget delivery of milestones.
• Maintain timelines and budgets; communicate progress to the molecule team.

Skills

Leadership

Communication

Problem-solving

Cross-cultural collaboration

Vendor management

Education

Bachelor’s degree in a science-related field

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Microsoft Project

Job description

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.

Responsibilities

• 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 effectively with colleagues at all levels; able to work with, and deliver, through others.
• Skilled at working through ambiguity and using effective problem-solving/solution-oriented approaches to help develop and evaluate molecule level strategies from lead to legacy.
• Successful in persuasion, influence, and negotiation skills in a matrix environment.
• Fosters spirit of learning agility, strategic thinking, and the ability to think differently to incorporate new learning.
• Contributes to the development of others by being an active source of constructive coaching and feedback to co-workers.

Requirements

• Bachelor’s degree in a science related field from an accredited college or university.
• 3 years’ experience in the pharmaceutical industry with direct experience of managing clinical studies, ideally in exploratory and biopharmaceutics clinical development (5+ year preferred).
• Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.
• Ability to influence and oversee TPOs to enable delivery of trial level deliverables.
• Demonstrated knowledge and experience with project management tools and processes.
• Demonstrated ability to work effectively cross-culturally and in a virtual work environment.
• Demonstrated ability to influence both internal and external environments appropriately and forge strong working relationships.
• Demonstrated problem-solving skills; able to anticipate and recognize systemic problems, diagnose root causes, and take corrective actions to prevent recurrence within the team.
• Strong self-management, organizational and interpersonal skills, and the ability to be flexible in varying environments and with multiple customer groups.
• Strong leadership and networking skills.
• Excellent oral and written communication skills; able to communicate clearly with team members and leadership.
• Strong computer skills; skilled at using Word, Excel, PowerPoint, and Microsoft Project.

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.