Program Operational Lead, Clinical Operations

Posted 2 months ago

Key responsibilities:

  • Serves as a core member of Core Team and Sub-team(s) representing Global Clinical Operations and contributes to the development of the Clinical Development Plan of the assigned program/indication
  • Conducts program level planning of the assigned program/indication to establish global resource requirements and high-level recruitment strategies
  • Accountable for the operational delivery (including risk management and mitigation) of the assigned program/indication and associated clinical trials and for all related strategic planning, prioritization of activities, within the program
  • Partners with the Medical Director and other Core Team members, actively offers operational insights and options to contribute to the program/indication and clinical trial strategy, with respect to clinical trial design and protocol optimization and timelines planning
  • Leads the Clinical Trial Teams in the execution of clinical trials and oversee the progress and deliverables (including trial budget and spending)
  • Provides guidance to Clinical Trial Teams during the development of the trial execution plan, managing trial budgetary issues, resolving trial issues, and implementing appropriate measures
  • Monitors Clinical Trial Teams and CRO/vendor performance through KPIs, and work with the appropriate Development Functional Leaders to optimize Clinical Trial Teams and CRO/vendor performance
  • Point of contact for escalation and resolution of trial related issues. Participates in vendor governance meetings to monitor and address performance issues and escalation/resolution of issues encountered by the Clinical Trial Teams
  • Provides oversight on operational quality and compliance in conjunction with Quality Assurance
  • Supervises Clinical Trial Teams in inspection readiness activities and attend Health Authority inspections to manage and answer/coordinates responses to inspection requests
  • Contributes and provides operational input into the due diligence activities
  • Authors/reviews Standard Operating Procedures (SOPs) for the conduct of clinical trial and acts as a Subject Matter Expert for training or SOPs
  • Participates in Clinical Operations Meetings and/or cross-functional forums to exchange information, best practices, and issues

Your profile

  • Bachelor’s Degree/Master’s Degree/PhD in Science or Healthcare
  • 8 years or more years of experience in pharmaceutical drug development with management in a matrix organization
  • Experience with FDA or EMEA inspections including sponsor GCP inspections
  • Strong team leadership with ability to manage multiple individuals and teams simultaneously
  • Strong problem-solving skills with ability to resolve issues with minimal supervision and understand when to escalate
  • Strong interpersonal skills with ability to effectively communicate, interact and work with individuals and teams and to bridge cross-functional stakeholder (business, scientific and technical)
  • Performance driven with ability to deliver results and fast in implementation
  • Strong knowledge of therapeutic area and fully knowledgeable in area of responsibility serving as source of expertise for others
  • Strong knowledge of clinical development processes and understanding roles and responsibilities of Clinical Trial Team members to drive execution of clinical development program
  • Strong knowledge in clinical trial forecasting, budgeting, and contracting
  • Fluent in English (French and another European language are an asset)

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