Clinical Study Team Lead

JOB INFORMATION ROLE SUMMARY

CSTL is accountable for planning and executing clinical studies, ensuring timely delivery within budget and quality standards, and leading multiple complex global studies or programs. The role involves collaboration with functional leadership for resource optimization and proactive risk management.

• A clinical operations and development specialist with extensive experience in planning and executing clinical studies, consistently applying this expertise to the design and conduct of trials in accordance with program and portfolio strategies for specific categories or therapeutic areas.

• Act as a strategic partner providing insights from a clinical operations perspective with functional lines and key stakeholders

• Serves as the primary contact responsible for providing input into study design, ensuring practical feasibility, streamlined planning, and timely delivery of clinical studies within approved budgets and quality standards.

• A skilled project manager and matrix leader, accountable for guiding multidisciplinary study teams in the successful execution of multiple complex global studies and programs.

JOB RESPONSIBILITIES

• Lead the study team and associated deliverables across all functions; accountable for managing and driving overall study timelines, budgets, and quality targets to meet or exceed business needs.

• Lead and coordinate the execution of clinical studies from sourcing strategy and study specification development for requests for proposals, study start-up through database release and inspection readiness to ensure timely delivery of quality study data.

• Provide input to and supports compilation of sections of the clinical study reports (CRSs).

• Accountable to ensure effective study team meeting scheduling, records, and communications.

• Accountable for strategic planning and decision making at the study level in line with program objectives.

• Accountable for issue resolution and act as point of awareness for clinical trial execution issues.

• Utilize negotiation, facilitation, meeting management, and conflict resolution skills to enhance cross- functional study team performance and accountable for effective study team operations.

• Lead study team chartering and team health check process.

• Partner and collaborate with functional line leadership to ensure optimal study team resourcing.

• May represent the study team at appropriate asset team and sub-team discussions

• Escalate issues to Clinical Operations Leadership when study team has been unable to resolve or adequately manage/mitigate. Quality and Risk Oversight

• Drive monitoring and remediation of quality metrics.

• Drive functional lines to ensure inspection readiness.

• Maintain active awareness and appropriate escalation of all Significant Quality Events (SQEs) reported for study and ensures appropriate prioritization and management of events through to resolution.

• Lead the study team in the management and communication of risk management plans including risk assessment and mitigation strategies.

• Proactively identify operational issues and lead the team in identifying options to de-risk and capitalize on opportunities.

• Maintain continuous study risk planning and guide the team in proactive issue resolution and risk management. Vendor Oversight

• Quality oversight of the Clinical Research Organization (CRO) if required by the Pfizer operating model and of the CRO deliverables related to study execution.

• Partner with relevant team functions to ensure vendor delivery meets quality and operational plan expectations Study Metrics & Reporting

• Act as a single, authoritative source of study information and lead study level status reporting per organizational norms and expectations.

• Ensure systems are maintained with up-to-date study status, risks, and issues.

• Oversee operational metrics across study and partner with functional lines to manage trends. Governance & Decision Points

• Drive proactive planning to navigate the team through governance and decision point milestones to support study deliverables to maintain development timelines.

• Lead preparation for and present the study to relevant governance per organizational norms and expectations. Additional Responsibilities may include: Program Level Support

• Develop execution strategies and oversee timelines, budgets, and quality across multiple studies. The program CSTL (pCSTL) may represent Clinical Operations on the asset team (per the organizational expectations and asset team charter), collaborating with clinical to ensure operational input provided for the clinical development plan (or equivalent), and providing input on program feasibility, budgets and timelines.

• Lead clinical operations' sub-team(s) where appropriate.

• Defines optimal execution strategy including early development candidates, concept plans (such as in support of the lifecycle and operating plan process) and for licensing and partnership opportunities.

• Lead program level feasibility & country strategy for inclusion in a Program Operational Plan.

• Develop and lead execution of data and document delivery plans at key milestones such as Proof of Concept (POC), key decision points, submissions, and rapid response.

• Contributes to oversight of strategic development partnerships and/or clinical research collaborations.

• May be a member of the Research &Development (R&D) due diligence team for business Partner with R&D leaders to assess development program timelines and budgets to inform the assessment of opportunities for the category.

• Monitor progress against plan; develop and implement formal operational risk management plans across the asset/program.

• Ensure comprehensive operational input to submission plan.

• Leads the delivery of Module 2/5 deliverables to support market authorizations including leading cross functional Module 2/5 submission sub- teams with accountability for overall operational strategy.

• Manage other submissions activities as necessary.

• Accountable for managing overall submission CD&O sub-team timelines, budgets, and quality targets.

• Accountable for building, forecasting, and managing the CD&O submission budget.

• Oversee operational metrics across submission sub-teams and manage trends and escalations. Non-project Initiatives

• Support Clinical Operations continuous improvements initiatives to maintain high standards of operation and quality within the organization.

• The asset team structure/nomenclature may vary between therapeutic areas, eg: Medicine Team, Global Development Team, Global Product Team

QUALIFICATIONS / SKILLS

• Extensive clinical studies conduct, global clinical study operations, and a thorough understanding of the processes associated with project and study management, knowledge of Good Clinical Practices (GCPs), ICH guidelines, monitoring, clinical, and global regulatory operations.

• Bachelor’s degree in one of the disciplines related to drug development or business required. Advanced degree desirable.

• Preferred 10 or more years of relevant experience. Prior Experience

Preferred:

• Broad experience in a clinical study execution discipline (e.g., senior study management expertise, lead data management expertise, clinical leadership expertise).

• Demonstrated project management and cross-functional leadership experience.

• Experience in understanding key drivers impacting budgets and experience building a Clinical Trial Budget and managing project to budget. Skills:

• Strategic thinking and targeted problem-solving skills.

• Ability to lead cross-functional teams, identify, resolve & escalate issues. • Project management expertise.

• Ability to leverage negotiation and conflict resolution skills to enhance team performance and delivery.

• Strong communication and interpersonal skills and ability to represent & communicate clearly to senior leaders and governance bodies.

(CTB) NON-STANDARD WORK