Clinical Operations

  • location: Malvern, PA
  • type: Permanent
  • salary: $160,000 - $170,000 per year

job description

Clinical Operations

Job Title: Director, Clinical Development

Position Description

  • The Associate Director/Director, Clinical Operations is responsible for the strategic and operational oversight of the Clinical Development programs. This includes trial development and management activities, including staffing, timelines and budget management. The Director will supervise internal staff and oversee use of outside vendors.
  • We are looking for a highly motivated, organized and efficient person who is passionate to make a difference in lives of people with psychiatric disorders. This person is a solid leader and a mentor to the clinical organization.
Position Responsibilities

  • Provide strategic and operational support for clinical programs, including protocol development and successful study execution
  • Develop strong expertise in relevant disease states and build productive relationship with KOLs
  • Interact with senior management regarding critical issues and status updates
  • Represent Clinical Operations on interdepartmental teams, including safety committee
  • Provide support to other departments to ensure timely execution of cross-functional objectives
  • Expand Clinical staff as needed to ensure timely program deliverables
  • Comply with US and International regulatory and clinical regulations
  • Ensure that Clinical Operations staff are trained and appropriate SOPs are in place
  • Other duties as needed or required
Position Requirements

  • Bachelor of Science degree required: preferable in Life Sciences or related discipline
  • Experience in clinical research, including hands on experience in clinical study execution

    • 10+ years experience denotes a Director level
  • 5+ years experience in a leadership/management role within clinical research
Preferred Skills

  • Medical device and/or Pharmaceutical experience in Psychiatry or Neurology preferred
  • Advanced degree in Life Sciences desirable
Other

  • Travel by air, rail, auto (% of time) - Required travel up to 50%
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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