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