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Job

Head of Clinical Operations

  • Location

    Los Angeles, CA

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Competitive

  • Contact:

    Cortland Hotz

  • Contact email:

    c.hotz@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    23 days ago

  • Expiry date:

    2020-08-31

  • Startdate:

    ASAP

Head of Clinical Operations

Location: Orange County, CA

Type: Full Time Permanent 

Salary: Excellent salary, bonus and accompanying benefits package

Amazing opportunity with a medical device company looking to widen their product's global presence.

This leadership role will lead the resourcing, development, training and management of a successful global clinical team.

 

Essential Duties and Responsibilities:

  • Provide leadership, strategic oversight, and guidance for Clinical Operations to the Executive team and key internal stakeholders (investors).
  • Create, execute and proactively manage clinical trial CROs and processes.
  • Plan, implement and oversee, Quality Checks for clinical projects, provide leadership and direction to ensure the highest standards for compliance with Company SOPs, GCP guidelines and global regulations.
  • Lead the effort to review and update clinical SOPs.
  • Lead the authorship of study protocols and investigator guides and managing the identification of and interaction with investigative sites, investigators, and study execution.
  • Develop and maintain strong relationships with CROs, external experts and Investigators to ensure effective execution of internal and external clinical projects.

Education and Experience:

  • The ideal candidate will have a bachelor’s degree in Life Sciences or Pharmacy, and an advanced degree (OD or MD) is preferred. 
  • A minimum of 10 years of direct experience with increasing levels of responsibility in the areas of clinical operations development and strategic planning; developing, implementing, and leading early to late stage clinical trials. 
  • In-depth understanding and experience across the clinical trial spectrum, with a track record of success in study planning, execution, and direct interface with FDA.
  • Therapeutic experience in Optometry and/or Ophthalmology with pivotal, multi-site clinical trials is highly desirable, and experience with clinical data management is a plus.
  • A results-oriented team player with strong interpersonal and communications skills, capable of working collaboratively with colleagues in a small high energy work environment.  

This position requires the individual to work at the office in the Orange Country area, with about 30%-40% travel.