Clinical Pharmacology Study Team Lead (Sr. Manager)

Remote, Virginia
July 30 2021
Position Type
Full Time
Organization Type
Job Type

The Clinical PharmacologyStudy Team Lead (CPSTL) will lead and manage the cross functional study team and is the single point of accountability for the operational delivery of one or more clinical studies from concept through reporting, including inspection readiness, submission and regulatory defense.

The CPSTL is an expert on the operational delivery of clinical trials and brings that expertise to the design & conduct of clinical studies in alignment with the program and portfolio strategies for the specific category(ies). The CPSTL will be responsible for developing timelines and budgets for their clinical studies and leading the execution of these studies according to time, cost and quality targets.

The CPSTL is responsible for proactive operational risk management for their clinical study(ies). This role will be accountable for planning and delivery to the Best-in-Class targets as well as optimal resourcing of the study team(s) and ensuring optimal study team(s) health.

Cross-functional team leadership of clinical trial delivery:
  • Single point of accountability for delivery from vendor selection through CSR/submission
  • Accountable for managing overall study timelines, budgets and quality targets for an individual protocol / program
  • Ability to lead and manage in an ambiguous, dynamic environment
  • Responsible for cross-functional team communication and effectiveness
  • Develop and maintain positive team dynamics and health
  • Disciplined project and risk management approach
  • Overall operational responsibility of clinical trial from study concept in development planning to submission/defense
  • Provides operational strategy for program/protocol development
  • Provides high quality study information to support timely decision making
  • Accountable for building, forecasting and managing the Clinical Trial Budget for the program

Drive operational delivery at the study level and across studies:
  • Establish and charter the study team
  • Lead the study team in achieving goals & milestones manages, facilitates and documents core study team meetings (e.g. meeting agendas & minutes, action logs and decision logs)
  • Accountable for delivery to improved cycle times metrics
  • Facilitate effective decision making
  • Lead the team in managing issues and problem solving
  • Demonstrate Leader Behaviors in motivating and supporting the study team
  • Ensures execution against study plan
  • Manage critical changes and/or variance in financial forecast, schedule scope and deliverables

Leads the study team to manage risk mitigation strategies including:
  • Identifying study level opportunities and risks
  • Preparing, maintaining, and implementing risk mitigation and contingency plans
  • Ensures progression of SQEs and resolutions
  • Ensures cross-functional awareness, buy-in and agreement to risk/opportunities, action plans and resolution
  • Ensures all key stakeholders / senior management are informed of study/program level major risks/opportunities and corresponding contingency /mitigation plans.
  • Ensures communication and integration of study level risks/opportunities at the program level
  • Responsible for coordinating, managing, and maintaining Inspection Readiness documents according to GSOP requirements (maintaining Study Team Roster, Vendor List, Systems List, Decision Log, SOP Log)

May perform some program level additional responsibilities.
  • Represent clinical operations on the asset level teams
  • Lead clinical operations' sub-team(s) where appropriate, in accordance with the organizational expectations and asset team charter
  • Establish and ensure adherence to operational standards and best practices for the asset or program
  • Manage and deliver to timelines, budget and quality for all studies in a program
  • Interface with the GCL and program level roles including at the CRO
  • BS - minimum of 8 years relevant experience
  • MS/PhD - minimum of 7 years relevant experience

Prior Experience 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 / leadership experience
  • Experience in understanding of key drivers impacting budgets
  • Experience in building a CTB and managing project to budget

  • Ability to lead cross-functional teams, identify, resolve & escalate issues
  • Ability to represent & communicate clearly at Governances
  • Ability to understand and assimilate high-level data from all functions



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