Los Angeles, CA
6 months ago
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 is a leadership position that will work closely with the SVP of RA/QA and report directly to the CMO. 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:
- Bachelor’s degree and an advanced degree is preferred.
- 7 years of experience in clinical operations development and strategic planning
- Extensive experience across the clinical trial spectrum, with a track record of success with the FDA.
- Therapeutic experience in Optometry and/or Ophthalmology
- A results-oriented team player with strong interpersonal and communications skills
This position requires the individual to work at the office in the Orange Country area, with about 30%-40% travel.
My team and I manage a slew of other full-time and contract positions for large, mid-size, and start up companies across the US (Pharma, Biotech, and Medical Device). If the above role isn’t for you but you’d nevertheless like to discuss your options in the market, I’d welcome a confidential discussion by phone or email. Please feel to reach out directly: (619) 350 - 6195 and/or email@example.com