Who We Are And What We Do
RenovoRx (NASDAQ: RNXT) is a Los Altos, CA-based biopharmaceutical company fighting cancer with a novel, targeted therapy platform currently in a Phase III clinical trial for its first indication: locally advanced pancreatic cancer. Our Company was the 2020 Winner of Fierce Biotech’s Life Sciences Innovation Award for Drug Delivery Technology.
What’s In It For You?
RenovoRx offers a competitive compensation and benefits package, including an annual bonus opportunity, stock options, medical/dental/vision, 401(k) (with match program), and paid holidays, vacation, and sick time. Additionally, you will have the opportunity to:
- Make an impact: your work will directly impact cancer patient populations where no improvements have been made in their treatment in decades
- Work with the best: The RenovoRx team is comprised of highly experienced and successful team members devoted to making an impact on cancer as well as helping others grow their careers
- Become your best: RenovoRx believes in culture and offers frequent team building events as well as employee growth and promotion opportunities
- Own it: you will be the CEO of your own job and be recognized for your hard work by your colleagues, investors, and, most importantly, study sites and patients
RenovoRx is an Equal Opportunity Employer and values diversity. We provide equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic characteristics, or any other category protected by applicable laws, regulations, and ordinances.
Open job opportunities:
Director of Clinical Operations
What You Will Bring to the Team
As the Director of Clinical Operations, your presence in our Los Altos office is critical to developing culture, maintaining accountability, and overseeing the day-to-day operations of the clinical team. You will report to our Chief Medical Officer, partner with our management team, and be responsible for translating our overall clinical strategy to short-term plans and ensuring the execution of those plans to achieve our overall annual and long-term corporate objectives.
This role is geared toward an individual who understands the fast-paced clinical environment, does not require definition to be effective, and spots issues and dives in. His/her key responsibilities include:
- Manage all aspects of clinical development, including handling the needs of a Phase III pancreatic cancer randomized trial, upcoming Phase II/III bile duct cancer trial, as well as other upcoming trials
- Manage multi-center oncology trials:
- Become a subject matter expert on RenovoRx clinical trial protocols
- Respond promptly to questions from Study Sites regarding protocol and study conduct
- Oversee patient enrollment, including enrollment goals and timelines, and ensure study proctors are prepared so they may assist as appropriate
- Oversee data collection and monitoring
- Assist with FDA inspections as needed
- Assist in pipeline development, including participating in protocol, CRF and strategy development, Clinical Study Report preparation, and NDA submissions
- Participate in the development, review, and implementation of departmental SOPs and processes
- Ensure all activities conducted by internal and external resources are performed following SOPs, established guidelines and work instructions, and appropriate industry, FDA, ICH guidelines and Good Clinical Practices (GCPs)
- Coordinate and manage vendors, including eTMF, study database, safety database, statisticians, data management, etc.
- Coordinate IRB submissions and communications
- Manage communication and regular meetings with Data Monitoring Committees (DMC)/Data Safety Monitoring Boards (DSMB)
- Present clinical project statuses to the clinical team and management as needed
- Oversee a team of 2-4 employees and contractors (i.e., Clinical Assistants, Clinical Research Associates, Clinical Specialists, Monitors, etc.)
- Oversee other clinical studies/goals in the future as determined by RenovoRx
Required Education
- Bachelor’s degree, RN or equivalent
Desired Experience
- Minimum of 10 years of experience in clinical research; oncology experience preferred
- Experience in clinical trials and clinical data analysis with the ability to manage large databases and maintain paper and electronic documents
- Experience leading and growing teams
- Energetic, forward-thinking, and creative with high ethical standards and good judgment
- Analytical, technical, and project management skills with the ability to work well under pressure and time constraints from competing priorities
- Possess the ability to see the larger picture perspective while being well-versed in different aspects of the company
- Broadly experienced with senior executives, ideally with both large pharma and emerging biotechnology organizations
- Resourceful, strategic, and analytical thinker who can help shape the future strategy of the company, anticipate potential challenges, and develop viable options to ensure successful outcomes
- Highly developed cross-functional collaboration and planning capabilities with the ability to integrate multiple points of view and inputs into an aligned plan with appropriate buy-in
- Detail-oriented with a high degree of accuracy and exactitude; ability to successfully lead and complete projects with multiple stakeholders
- Excellent interpersonal, analytical, and leadership skills
- Highly proficient with Microsoft Office applications (Outlook, Word, Excel, and PowerPoint)
Additional Details
This in-house position is based in Los Altos, California but may require travel to clinical sites as necessary. The role will require the ability to sit for extended periods using a computer or a phone, share a workspace maintained in good order, potentially lift up to 20 lbs., and work alone or with others in a small office environment.
Clinical Research Associate
What You Will Bring to the Team
As a Clinical Research Associate (CRA), your presence in our Los Altos office is critical to collaborate with the entire clinical research team. You will report to a Clinical Trial Manager (CTM) and the Director of Clinical Operations. You will help with the execution and maintenance of RenovoRx clinical studies according to ICH and GCP standards.
This role is geared toward an individual who understands the fast-paced clinical environment, does not require definition to be effective, and spots issues and dives in. His/her key responsibilities include:
- Develop a strong understanding of RenovoRx clinical study protocols
- Collaborate closely with clinical research sites to ensure adherence to study protocols and terms of the studies
- Drive clinical sites to maintain the EDC on a timely basis and collaborate with field based CRAs to query and assist in accurate data management
- Collect screening logs from sites and work to assist in enrollment challenges
- Maintain, update, and, when required, establish databases for clinical activity tracking
- Track incoming and outgoing clinical and regulatory documents and updates for investigator sites
- Assist CTA with maintaining the electronic Trial Master File (eTMF) following the Drug Information Association’s reference model and periodically reviews (QCs) to ensure accuracy and completeness
- Monitor subjects through their journey to ensure successful enrollments, randomization and treatment according to the protocol
- Coordinate clinical study training when appropriate with the Clinical Trial Manager and field based CRAs
- In collaboration with the clinical study team, responsible for tracking, filing, and follow up of SAEs with clinical sites promptly, per the Safety Management Plan
- Prepare for CRA, Study Coordinator, or Investigator Meetings, as needed, including scheduling, tracking, preparation and creating, distributing, and filing of meeting minutes
- Maintain tracking information for study activities, including site qualification, site activation, site initiation, interim monitoring, and close-out visits
- Assist in audits and inspections to ensure data is available and clean
- Ensure site IRB statuses are current and the CTM is notified of changes to 1572s, site contacts and other critical contacts
All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with the company’s Standard Operating Procedures. This is an opportunity for an experienced CRA/CTA position to have the opportunity to function at a higher level with mentorship in a fast-paced start-up environment.
Required Education
- Bachelor’s degree
Desired Experience
- Minimum of 2 years of experience as a CRA/CTA
- Experience working on oncology clinical trials is preferred
- Experience working on Phase II/III oncology clinical trials
- Energetic, forward-thinking, and creative with high ethical standards and good judgment
- Analytical, technical, and project management skills with the ability to work well under pressure and time constraints from competing priorities
- Possess the ability to see the larger picture perspective while being well-versed in different aspects of the company
- Resourceful, strategic, and analytical thinker who can help shape the future strategy of the company, anticipate potential challenges, and develop viable options to ensure successful outcomes
- Highly developed cross-functional collaboration and planning capabilities
- Detail-oriented with a high degree of accuracy and exactitude; ability to successfully lead and complete projects with multiple stakeholders
- Excellent interpersonal, analytical, and leadership skills
Additional Details
This is an in-house position based in Los Altos, California but it may require travel to clinical sites. The role will require the ability to sit for extended periods using a computer or a phone, share a workspace maintained in good order, potentially lift up to 20 lbs., and work alone or with others in a small office environment.
Clinical Trial Associate
What You Will Bring to the Team
As a Clinical Trial Associate (CTA), your presence in our Los Altos office is critical to collaborate with the entire clinical research team. You will report to a Clinical Trial Manager (CTM) and the Director of Clinical Operations (DCO). You will support the entire clinical team to assist with the execution and maintenance of RenovoRx clinical studies according to ICH and GCP standards.
This role is geared toward an individual who understands the fast-paced clinical environment, does not require definition to be effective, and spots issues and dives in. His/her key responsibilities include:
- Develop a strong understanding of RenovoRx clinical study protocols
- Work with the clinical team for designated project communications, correspondence, and associated documentation
- Maintain, update, and, when required, establish databases for clinical activity tracking
- Track incoming and outgoing clinical and regulatory documents and updates for investigator sites
- Prepare, handle, distribute, file, and archive clinical documentation and reports
- Maintain the electronic Trial Master File (eTMF) following the Drug Information Association’s reference model and periodically reviews (QCs) to ensure accuracy and completeness
- Maintain and update the CTMS (Clinical Trial Management System) with site information, study contacts, regulatory documents, Interim Monitoring Visits (IMV) visits, tracking of IMV reports, and runs reports as needed
- Update and maintain clinical systems within project timelines
- In collaboration with the clinical study team, responsible for tracking, filing, and follow up of SAEs with clinical sites promptly, per the Safety Management Plan
- Take and issue meeting agendas and minutes for designated clinical team meetings
- Prepare for CRA, Study Coordinator, or Investigator Meetings, as needed, including scheduling, tracking, preparation and creating, distributing, and filing of meeting minutes
- Maintain tracking information for study activities, including site qualification, site activation, site initiation, interim monitoring, and close-out visits
- Maintain training documents for newly onboarded team members
- Prepare Regulatory Binders for Clinical Sites
- Partner with other functional areas and clinical sites to track clinical samples for the specialty studies per the protocol (i.e., PK studies)
- Conduct a data review and/or informed consent development and review as needed
Required Education
- Bachelor’s degree
Desired Experience
- Experience working on oncology clinical trials is preferred
- Experience working on Phase II/III oncology clinical trials
- Energetic, forward-thinking, and creative with high ethical standards and good judgment
- Analytical, technical, and project management skills with the ability to work well under pressure and time constraints from competing priorities
- Possess the ability to see the larger picture perspective while being well-versed in different aspects of the company
- Resourceful, strategic, and analytical thinker who can help shape the future strategy of the company, anticipate potential challenges, and develop viable options to ensure successful outcomes
- Highly developed cross-functional collaboration and planning capabilities
- Detail-oriented with a high degree of accuracy and exactitude; ability to successfully lead and complete projects with multiple stakeholders
- Excellent interpersonal, analytical, and leadership skills
Additional Details
This is an in-house position based in Los Altos, California but it may require travel to clinical sites. The role will require the ability to sit for extended periods using a computer or a phone, share a workspace maintained in good order, potentially lift up to 20 lbs., and work alone or with others in a small office environment.
Research Assistant Intern
What You Will Bring to the Team
As a Research Assistant Intern you will report to our Chief Medical Officer (CMO). The ideal candidate has excellent written communication and organizational skills, experience writing abstracts and publications, and is able to prioritize projects while maintaining a strong attention to detail.
This role is geared toward an individual who understands the fast-paced clinical environment and does not require definition to be effective. His/her key responsibilities include:
- Research publications: help prepare manuscripts and coordinate submissions
- Presentations: assist with preparation of PowerPoint slides and conference posters
- Literature Searches: conduct limited literature searches for relevant articles in coordination with in-house teams
- Data Analysis: assist in pulling data from relevant databases, prepare tables
- Other assignments as may be agreed to by Consultant and the Company’s Chief Operating Officer(COO) or CMO as appropriate.
Required Education
- BA/BS degree
Desired Experience
- Excellent written and verbal communication skills
- Excellent organizational skills, with attention to detail
- Comfortable in a highly collaborative environment with the ability to work well independently
- Ability to prioritize, problem solve, manage time effectively and work with minimal supervision
- Positive and enthusiastic attitude with the ability to adapt to changing project demands
- Ability to follow instructions and be a proactive problem solver
- Detail-oriented with a high degree of accuracy and exactitude
Additional Details
The role will require the ability to sit for extended periods using a computer and work alone or with others in a small office environment.