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Clinical Study Team Lead
3 months ago
ROLE SUMMARY
Why Patients Need You
Join us, and be a part of a team that values innovation, collaboration, and the relentless pursuit of excellence. Together, we can lead the way in healthcare and make a lasting impact on society.
What You Will Achieve
As a Clinical Study Team Lead (CSTL), you will be an integral member of Pfizer's clinical development team and a matrix leader accountable for study team delivery of multiple complex global studies and/or programs. Your clinical development expertise in the execution of obesity clinical trials will enable contributions to the design and conduct of obesity clinical studies in alignment with the program and portfolio strategies for the Internal Medicine Therapeutic Area. Your project management skills will be leveraged to develop clinical trial timelines and oversee budgets for the assigned clinical studies/programs. Your ability to partner and collaborate with functional line leadership will be instrumental in ensuring optimal resourcing of the study teams. While managing complex project environments, you will anticipate potential project risks and influence teams to develop proactive risk management and inspection readiness plans. In this role, your strong leadership skills and clinical operations expertise will help make Pfizer ready to achieve new milestones and help patients across the globe.
ROLE RESPONSIBILITIES
Study Team Leadership
- Lead study teams and associated deliverables across all functions; accountable for managing and driving overall study timelines, budgets and quality targets to meet or exceed business needs
- Accountable for strategic planning and decision making at the study-level in line with program objectives
- Represents the study team at appropriate medicine team and sub-team discussions
- Partner and collaborate with functional line leadership to ensure optimal resourcing of the study teams
- Drive functional lines to ensure inspection readiness; ensure maintenance and accuracy of Standard Operating Procedures (SOP) log
- Maintain active awareness and appropriate escalation of all Significant Quality Events (SQEs) reported for study and ensure appropriate prioritization and management of events through to resolution
- Utilize negotiation, facilitation, meeting management, and conflict resolution skills to enhance cross-functional study team performance and be accountable for effective study team operations
- Accountable for issue escalation and resolution
- Lead study team chartering and team health check process
Governance & Decision Points
- Drive proactive planning to navigate the team through governance and decision point milestones to support on-time delivery of study to maintain development timelines
- Develop and lead execution of data and document delivery plans at key milestones such as Proof of Concept and Phase 3 decisions
- Lead preparations for and present the study to relevant governance per organizational norms and expectations
Risk Management
- Proactively identify operational issues and lead the teams in identifying options to de-risk and capitalize on opportunities
- Lead the study teams in proactive problem solving, management and communication of risk management plans including risk assessment and mitigation strategies
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 program status, risks, and issues
- Oversee operational metrics across study(-ies) and partner with functional lines to manage trends
- Accountable for managing overall submission of Clinical Development & Operations sub-team timelines, budgets, and quality targets
Submissions
- Ensure comprehensive operational input to submission plan
- Lead cross functional Module 2/5 submission sub-teams with accountability for delivery and overall operational strategy to ensure data and document delivery to support submissions and rapid response. Manage other submission activities as necessary
- Oversee operational metrics across submission sub-teams and manage trends and escalations
BASIC QUALIFICATIONS
Training and Education:
- Bachelor’s degree (BS/BA) in science, health-related field or epidemiology, or a discipline related to drug development or business required
- 10+ years of relevant experience (prior clinical trial, non-interventional study and/or epidemiologic study)
Prior Experience:
- Extensive experience in conduct of multiple obesity clinical trials and clinical trial operations with glucagon-like peptide-1 (GLP-1) agonists and/or glucose-dependent insulinotropic polypeptide (GIP) compounds strongly preferred.
- Broad experience in a Clinical Trial Execution discipline (e.g. senior study management expertise, lead data management expertise, clinical leadership expertise)
- Demonstrated project management and cross-functional leadership experience associated with project
