Late stage, medical device start-up seeking a new Director of Clinical Research in Orange County. This Director of Clinical Research will be focusing on pre-market clinical work for class II dental medical devices. This role is a direct hire position, on-site, and offers competitive pay with equity.
Day to Day Responsibilities:
- Participate in developing and managing company's product and procedure road map
- Work closely with physicians, key opinion leaders, scientific advisors and various functional teams within the company to develop innovative and paradigm shifting procedures and technologies.
- Work with Sr. management to establish objectives, plans, and time lines and execute pre-clinical (in-vitro and animal) and pre-market clinical studies consistent with business and customer needs. Includes US and international studies, regulatory filings and approvals, marketing requirements including publications, white papers, presentations, and other objectives aligned with the Company's overall goals.
- Develops study protocol, recruit patients, case report forms, data management and procedures required in all aspects of conducting clinical studies.
- Manages clinical study budget and ensures time lines are being driven in accordance with the goals and objectives of the Company.
- Provides leadership and oversight of clinical teams, internal and external (CRO), to ensure GCP compliance and adherence to Quality systems.
Must Have Skills:
- MS or PhD degree in engineering or life sciences
- Minimum 7 years of clinical research experience and publications in prestigious scientific journals
- Must have demonstrated skills and track record of project management and leadership
- Experience in Class II medical devices; dental device experience preferred
- ACRP or SOCRA certified preferred
- Understand GCP ICH E6 and HIPAA requirements
- Management experience of 4 or more direct reports
- Problem solving and
- Must be innovative, entrepreneurial, strategic thinker, Independent, self-motivated, self-starter, fast-learner.
Sthree US is acting as an Employment Agency in relation to this vacancy.