Clinical Study Team Lead

4 weeks ago


La Jolla, California, United States Pfizer Full time

ROLE SUMMARY



Why Patients Need You



Pfizer's purpose is to deliver breakthroughs that positively impact patients' lives. Research and Development plays a vital role in fulfilling Pfizer's purpose by translating advanced science and technologies into essential therapies and vaccines. Whether you are involved in discovery sciences, drug safety, clinical trials support, you will utilize cutting-edge design and process development capabilities to speed up the delivery of top-notch medicines to patients worldwide.



Join our team, where we value innovation, collaboration, and strive for excellence. Together, we can lead the way in healthcare and create a significant impact on society.



What You Will Achieve



As a Clinical Study Team Lead (CSTL), you will play a key role in Pfizer's clinical development team, leading the study team in delivering multiple complex global studies and programs. Your expertise in obesity clinical trials will contribute to designing and conducting studies aligned with program strategies. Your project management skills will be essential in developing trial timelines, managing budgets, and ensuring optimal resourcing of study teams. Your leadership and operational expertise will prepare Pfizer to reach new milestones and help patients globally.



ROLE RESPONSIBILITIES



Study Team Leadership


  • Lead study teams across all functions, managing study timelines, budgets, and quality targets
  • Strategic planning and decision-making at the study level
  • Represent the study team at relevant discussions
  • Collaborate with functional line leadership for optimal team resourcing
  • Drive teams for inspection readiness
  • Ensure proactive risk management
  • Facilitate cross-functional team performance
  • Lead study team chartering and team health check process

Governance & Decision Points


  • Plan for governance and decision point milestones
  • Lead data and document delivery plans
  • Prepare and present the study at relevant governance meetings

Risk Management


  • Proactively identify operational issues
  • Lead teams in risk management strategies

Study Metrics & Reporting


  • Act as a source of study information
  • Oversee operational metrics and trends
  • Manage submission timelines, budgets, and quality targets

Submissions


  • Ensure operational input to submission plan
  • Lead submission sub-teams and manage data delivery
  • Oversee metrics across submission teams

BASIC QUALIFICATIONS


Training and Education:


  • Bachelor's degree in a related field
  • 10+ years of relevant experience

Prior Experience:


  • Extensive experience in conducting obesity clinical trials
  • Project management and leadership skills
  • Good Clinical Practices knowledge
  • Budget management experience
  • Leadership capabilities

Skills:


  • Strategic thinking and problem-solving
  • Strong communication and interpersonal skills
  • Ability to lead teams and resolve conflicts
  • Effective representation to senior leaders
  • Data assimilation skills

PREFERRED QUALIFICATIONS


  • Advanced degree



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