Clinical Study Group Lead

Why Patients Need You
Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best-in-class medicines to patients around the world.

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 Group Lead, you will be an operational and clinical development leader accountable for delivery of your assigned portfolio comprised of multiple, complex global programs and studies. You will partner with the Clinical Operations Head and other leaders in early and late phase development to generate innovative operational strategies that are aligned with the clinical development plans and advance the portfolio. Your clinical development expertise in the leadership and execution of clinical trials will enable contributions to the design and conduct of clinical studies in the respective Therapeutic Area(s). You will ensure appropriate operational contributions are provided to governance committees relating to clinical study operations and submissions. You will be accountable for Clinical Operations leadership of Module 2 & 5 submission subteams and endgame inspection readiness. In the Clinical Study Group Lead role, you will be responsible for talent development and supervision of Clinical Study Team Leads (CSTLs) in your group along with mentoring and coaching CSTLs on best practices – in alignment with the Clinical Operations Head’s strategy. You will also be responsible to ensure the CSTLs are effectively leading the studies through the various stage gates of development (i.e. First in Human/ First in Patient, Proof of Concept, Decision Points, Quality Gates, etc.). You will also oversee the management and driving of overall study timelines, the quality and accuracy of data inputs for reporting on study performance, budgets and quality targets to meet or exceed business needs. Your ability to collaborate cross-functionally and leverage relationships across divisions will be instrumental in ensuring optimal resourcing of the study teams. Your ability to anticipate potential project risks, exercise foresight and judgment in initiating, planning, organizing and guiding complex projects will help make Pfizer ready to achieve new milestones and help patients across the globe.

ROLE RESPONSIBILITIES

Portfolio Operational Leadership

• Accountable for operational strategic planning and delivery of respective portfolio of assets or studies
• Accountable to deliver excellence in clinical study team leadership for a portfolio of clinical trials, ensuring the trials progress in accordance with agreed clinical and operational plans
• Ensure appropriate operational contributions are provided to governance committees relating to clinical study operations and submissions
• Oversee management and driving of overall study timelines, quality and accuracy of data inputs for management reporting on study performance, budgets and data quality targets for assigned portfolio
• Provide single point of responsibility for partner lines and stakeholders for assigned portfolio
• Ensure CSTL leadership of Module 2/5 submission subteams with accountability for overall operational strategy and delivery of data and documents in support of submissions and rapid response
• Accountable for endgame inspection readiness for assigned portfolio
• Responsible to ensure adequate resourcing for projects in assigned portfolio

Clinical Operations Line Management

• Support CSTLs to address emergent issues and ensure rapid communication of critical issues to Clinical Operations Head as appropriate
• Responsible for the identification, selection, development, performance management, mentoring/training, retention and engagement of a group of up to 15 CSTLs.
• Accountable to ensure assigned group of CSTLs possess appropriate team leadership, functional, and technical skills to enable successful leadership of the study teams
• Hold regular coaching and feedback sessions with CSTLs within group and maintains a diverse, high performing team
• Develop & implement strategies to maximize competency in leadership and clinical project management and skills related to cross functional team leadership
• Potential to work at the program/asset or study level if needed and assume CSTL respo