Director of Clinical Operations

Silicon Valley - Bay Area - California
Feb 27, 2018
Required Education
Bachelors Degree
Position Type
Full time

RenovoRx is an exciting medical technology startup that has developed a chemotherapy delivery system, already cleared by the FDA and CE marked, that is initially slated for targeted pancreatic cancer treatment.  Early human clinical data has demonstrated greater than two year survival in this challenging patient population.  The company is in the process of launching a Pivotal/Phase 3 randomized control trial to further validate these findings and secure an orphan drug/device combination for first line therapy for Stage 3 pancreatic cancer.  


Sr. Manager/Director of Clinical Research Job Description

This employee handles the general needs of RenovoRx’s Pivotal/Phase 3 randomized control trial and post-market clinical registry studies.

Reports to:  Chief Medical Officer

Job Responsibilities:



  • Responsible for the overall management of multi-center oncology trial conducted by the company- responsibilities will include
  • Become a subject matter expert on RenovoRx clinical trial protocols
  • Respond to questions from Study Sites regarding protocol and study conduct as they arise
  • Overseeing patient enrollment including enrollment goals and timelines
  • Overseeing data collection and monitoring
  • Submissions and communications to/with IRBs
  • Help in implantation of database from paper data collection to Electronic database
  • Drive site identification and site qualification 
  • Work with internal and external teams including, but not limited to regulatory affairs, statisticians, and others as necessary
  • Coordinate communication with Data Monitoring Committee/Data Safety Monitoring Board and organize regular meetings
  • Maintain Clinical Research Project Dashboards and present updates to company’s weekly meetings and to management as needed
  • Oversee team of 2-4 employees and contractors (ie. Clinical Assistants, Clinical Research Associates, Clinical Specialists, Monitors, etc)
  • Monitor data, including SAEs
  • Oversee other clinical studies/goals in the future as determined by the company
  • This position is an in house position but may require some travel (<30%) to clinical sites
  • Other clinical and/or regulatory assignments may be added in the future

Minimum Requirements:

  1. Bachelor’s degree, RN, or equivalent
  2. Minimum of 5 years of experience in clinical research including oncology experience
  3. Proficient in computer skills including MS Word, Excel, PoewerPoint, various EDC systems (ie. MediData, Medrio)
  4. Excellent communication skills, organization skills, and attention to detail
  5. Ability to work well with a small team and an independent self-starter
  6. Ability to take the lead and responsibility on multiple projects as well perform the entire spectrum of work as needed