Los Angeles, CA
23 days 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 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.