Clinical Study Team Lead

Pfizer • Berlin, PA

10h • $176,600 - $294,300 • Hybrid

About The Position

The Clinical Study Team Lead (CSTL) plans and executes clinical studies, ensuring timely delivery within approved budgets and quality standards. The role applies clinical operations and development expertise to trial design and conduct in alignment with program and portfolio strategies, and provides strategic operational input to functional leaders and stakeholders. As the primary operational contact for a study, the CSTL helps ensure its design is feasible and its planning is streamlined.

The CSTL leads multidisciplinary teams and is accountable for execution of multiple complex global studies or programs. Responsibilities can also extend to program-level execution strategy, submissions, operational planning, and continuous improvement initiatives. The position is hybrid and may require travel for team or site meetings and meetings outside standard working hours to accommodate a global team.

Requirements

• Bachelor’s degree in a discipline related to drug development or business.
• Extensive experience in clinical study conduct and global clinical study operations, with thorough understanding of project and study management processes.
• Knowledge of Good Clinical Practices (GCP), ICH guidelines, monitoring, clinical operations, and global regulatory operations.
• Demonstrated project-management and cross-functional leadership experience.
• Strategic thinking and targeted problem-solving skills.
• Ability to lead cross-functional teams and identify, resolve, and escalate issues.
• Project-management expertise.
• Ability to use negotiation and conflict-resolution skills to improve team performance and delivery.
• Strong communication and interpersonal skills, including the ability to represent and communicate clearly to senior leaders and governance bodies.
• Ability to influence and collaborate with peers, develop and coach others, and guide colleagues’ work to achieve meaningful outcomes and business impact.
• Permanent work authorization in the United States; U.S. work visa sponsorship is not available.

Nice To Haves

• Advanced degree.
• 10 or more years of relevant experience.
• Broad experience in a clinical study execution discipline, such as senior study management, lead data management, or clinical leadership.
• Experience understanding key budget drivers, building a Clinical Trial Budget, and managing a project to budget.
• Leadership experience that includes developing and coaching others.

Responsibilities

• Lead study teams and cross-functional deliverables, managing overall study timelines, budgets, and quality targets.
• Coordinate clinical study execution from sourcing strategy and request-for-proposal specifications through start-up, database release, and inspection readiness.
• Provide input to and support compilation of clinical study report sections.
• Ensure effective study-team meeting scheduling, recordkeeping, and communications.
• Make study-level strategic plans and decisions in line with program objectives.
• Resolve study execution issues and serve as a point of awareness for emerging issues; escalate unresolved or inadequately managed issues to Clinical Operations Leadership.
• Use negotiation, facilitation, meeting-management, and conflict-resolution skills to support team performance and operations.
• Lead study-team chartering and team health checks.
• Collaborate with functional line leadership to optimize study-team resourcing.
• Represent the study team at relevant asset-team and sub-team discussions as needed.
• Monitor and remediate quality metrics, and drive functional lines to maintain inspection readiness.
• Track Significant Quality Events for the study, ensure appropriate prioritization and management, and oversee them through resolution.
• Lead study risk planning, assessment, mitigation, communication, and proactive issue resolution.
• Provide quality oversight of CROs and their study deliverables when required by the operating model; collaborate with functions to ensure vendors meet quality and operational expectations.
• Serve as the authoritative source of study information, lead status reporting, and keep systems current with study status, risks, and issues.
• Oversee study operational metrics and work with functional lines to manage trends.
• Plan for governance and decision-point milestones, prepare the study for governance review, and present it according to organizational expectations.
• Where applicable, develop execution strategies and oversee timelines, budgets, and quality across multiple studies; provide operational input to asset teams and clinical development plans.
• Lead clinical operations sub-teams when appropriate and define execution strategies for early development, lifecycle planning, licensing, and partnership opportunities.
• Lead program-level feasibility and country strategy for inclusion in a Program Operational Plan.
• Develop and lead data and document delivery plans for milestones such as proof of concept, key decisions, submissions, and rapid response.
• Contribute to oversight of strategic development partnerships and clinical research collaborations; participate in R&D due diligence as needed.
• Assess program progress against plan and develop and implement formal operational risk-management plans.
• Provide operational input to submission plans and lead delivery of Module 2/5 deliverables, including cross-functional submission sub-teams and operational strategy.
• Manage other submission activities as necessary; oversee submission CD&O sub-team timelines, budgets, quality targets, budget forecasting, metrics, trends, and escalations.
• Support Clinical Operations continuous-improvement initiatives to maintain organizational standards of operation and quality.
• Travel for team or site meetings and attend meetings outside standard working hours when needed to accommodate a global team.

Benefits

• 401(k) plan with Pfizer matching contributions and an additional Pfizer Retirement Savings Contribution.
• Paid vacation, holidays, and personal days.
• Paid caregiver, parental, and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Eligibility for Pfizer’s Global Performance Plan, with a stated bonus target of 20% of base salary.
• Eligibility to participate in a share-based long-term incentive program.
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior