Job Description – Director of Clinical Operation - Remote

We are a clinical stage pharmaceutical company in Tucson, AZ. Our mission is to develop breakthrough oxygen therapeutic solutions to life threatening diseases. Director of Clinical Operation manages clinical operation department. This is a very strategic as well as execution role, as the company has just launched oncology trial in US, and we have upcoming trials outside of US. This position is crucial in our success. We are looking for someone who can see the “big picture” of company’s development and clinical map, while does not mind to roll up his/her sleeve for day to day activities. If interested, please send your resume and/or cover letter to accounting@nuvoxpharma.com

Responsibilities

Provide leadership to the Clinical Operations Department; Responsible for overall clinical operation, including but not limited to:

• Site qualification and initiation
• Site and data monitoring
• Site activity coordination, including AE/SAE reporting, Q&A, etc.
• Support medical monitor and DSMB
• CRO and investigator management
• Key member to support regulatory body correspondence of the trials
• Lead the clinical ops team and coordinate with R&D and manufacturing

Job Requirements

• Minimum of a bachelor’s degree in a scientific or health care discipline preferred
• Prior experience in pharmaceutical or biotech industry
• Excellent knowledge of GCP
• Attention to details and “put pieces together”
• 7-10 years supporting clinical trials at sponsor(s)
• Highly effective team player with exceptional interpersonal skills building relationships with clinical trial sites
• Ability to lead employees and coordinate with other departments.
• Ability to utilize critical thinking to analyze problems which may require multiple factors and approaches
• Sound judgement and problem solver – know when to escalate, report and make good decisions based on business objectives.
• Excellent oral and written communication skill
• This position requires some travel
• Knowledge about European and/or Canadian regulatory requirements for clinical trials is highly appreciated, but not mandatory.