Director, Clinical Programs

Director, Clinical Programs

Director, Clinical Programs


Job Code: 72028
Location: Irvine, CA US
Travel Involved: 70-80%
Job Type: Full Time
Job Level: Executive (SVP, VP, Department Head, etc)
Education: Master's Degree
Skills:
Category: Healthcare - Other
Position Summary:

Director, Clinical Programs

In this leadership role, you will be responsible for coordinating and managing all aspects of the Company's Clinical Trials programs, both domestically and in Europe. You will also maintain preparation of documentation packages to enable Clinicians to prepare submissions for review by either IRBs or Safety Committees of local authorities to obtain clearance for clinical trials of evolving versions of our system. Additionally, you will manage the data collection, site audits, CRAs and participate in data review, analysis and creation of detailed clinical reports for each case and site.

Responsibilities:
· Design, document and execute clinical protocols as needed for regulatory approval in the United States and Europe
· Work closely with Product Development, Marketing and Regulatory Affairs
· Report any design deficiencies or product complaints to Product Development
· Attend relevant scientific and/or medical meetings
· Prepare accurate and timely reports to management on study progress
· Assist in the preparation of IDE, 510(k), PMA and/or design dossier submissions
· Develop relationship with investigators to quickly and effectively resolve any study discrepancies
· Ensure compliance with the protocol, FDA and international regulations, IRB/EC requirements, company procedures, and overall clinical objectives
· Direct the activities of subordinates within the department
· Prepare and conduct investigator meetings
· Maintain IRB submissions through tracking of approvals and submission of periodic reports
· Manage external contacts (clinical research organization, DSMB, CEC, investigators, site study coordinators, IRBs/ECs)
· Ensure full compliance with regulations to ensure acceptability of data to meet regulatory requirements



Requirements

Qualifications:
· Master's degree or equivalent or 4-10 years related experience and/or training; or equivalent combination of education and experience
· High familiarity with OR/ICU protocols and procedures
· Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations
· Ability to write reports, business correspondence and procedure manuals
· Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public
· Ability to define problems, collect data, establish facts and draw valid conclusions
· Knowledge of Microsoft Office Word, Excel and Outlook and Internet software
· Ability to travel up to 75% of the time – both international and domestic

Benefits:
We value our employees’ time and efforts. Our commitment to your success is enhanced by our extensive competitive salary of $125K-$175K annually, depending on experience level, and an excellent benefits package including paid time off, medical, dental and vision benefits and future growth opportunities within the company. Plus, we work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning and culture.