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Head of Clinical Operations

Company: Alexza Pharmaceuticals
Location: Mountain View
Posted on: February 20, 2021

Job Description:

  • Manages overall clinical operations of all clinical programs including project planning, budget, resource management and contract research organization (CRO) management.
  • Contributes to the development and implementation of clinical product development plans
  • Manages all aspects of clinical studies to ensure studies are completed on time, within budget, and in compliance with SOPs, applicable regulations, and other drug/device requirements
  • Overall management of clinical trial conduct and all deliverables beginning with site/investigator selection through delivery of clinical study reports
  • Manages GCP Compliance for all Alexza clinical programs
  • Process owner for all GCP and Pharmacovigilance SOPs.
  • Manages the GCP Audit Program including investigational site and vendor audits.
  • Oversees the selection of Investigational Sites and external Contract Research Organizations (CRO)
  • Works closely with clinical personnel including in-house and contract staff
  • Collaborate with R&D staff on product development
  • Collaborate with R&D staff on clinical supplies required for conducting clinical trials
  • Acts as cross functional liaison to ensure study plan aligns with business development strategies.
  • May serve as host for GCP regulatory inspections. Skills required
    • Previous clinical operations experience and judgment to plan and accomplish goals.
    • Perform a variety of complicated tasks, and will be expected to show a wide degree of creativity and latitude under limited guidance.
    • Project prioritization skills and ability to plan and execute tasks in a structured manner.
    • Able to solve complex technical problems independently or as part of a team.
    • Solid hands on management of daily tactical operations
    • Strong interpersonal skills to facilitate interaction among clinical groups and project teams
    • Strong oral and written communication skills
    • Strong organizational and project management skills and attention to details
    • Creative in developing solutions to resolving technical and business issues
    • Self-motivated, goal-oriented, and able to work effectively with minimal supervision
    • Broad overview of clinical pharmacology and safety
    • Knowledge of drug development and clinical trials in multiple therapeutic areas and hands-on experience in the design and implementation of clinical studies
    • Advanced data analysis and modeling skills, a plus
    • Ability to work in an early-stage company environment which requires flexibility, innovative resource identification, and hands-on operational responsibilities Education and experience
      • BA/BS in Life Sciences or health-related field with a minimum of 8 years practical clinical operations management experience and 10+ years relevant life sciences experience.
      • Experience in GCP Compliance or auditing of clinical sites
      • Experience in the pharmaceutical or medical device industries
      • Thorough knowledge of FDA regulatory requirements and guidelines essential
      • Demonstrated proficiency in the implementation and monitoring of clinical trials
      • Ability to manage contract personnel, investigational sites and CRO's
      • Willingness to travel as necessary
      • Experience in CNS and specifically in Neurology is preferred Physical Requirements
        • Prolonged periods of sitting at a desk and working on a computer
        • Must be able to lift up to 15 pounds at times

Keywords: Alexza Pharmaceuticals, Mountain View , Head of Clinical Operations, Healthcare , Mountain View, California

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