Careers

As an innovative and growing biopharmaceutical company, RenovoRx is seeking team members with talent and skills to work in an evolving and fast-paced environment focused on the shared goal of improving patient outcomes for those undergoing cancer treatment.

Open job opportunities:

Senior/Clinical Trial Manager

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 3 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 You Will Bring to the Team

As the Sr./Clinical Trial Manager, 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 Director of Clinical Research, partner with our management team, and be responsible for translating our overall clinical strategy to short-term plans and ensuring execution on 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 who spots issues and dives in. His/her key responsibilities include:

  • Manage all aspects of clinical development including handling the needs of a Phase 3 pancreatic cancer randomized trial, upcoming Phase 2/3 bile duct cancer trail as well as other upcoming trials
  • Overall management of multi-center oncology trials conducted by the company- Responsibilities 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/ECs
  • Work with internal and external teams including, but not limited to, safety, regulatory affairs, statisticians, CROs, and others as necessary
  • Coordinate communication with Data Monitoring Committee/Data Safety Monitoring Board and organize regular meetings
  • Maintain Clinical Research Project status and present updates to company’s weekly meetings and to management as needed
  • Establish study/program milestones and ensure accurate tracking and reporting of study/program metrics and timelines, and critical study activities
  • Develop and maintain enrollment and budget forecasts
  • Oversee team of 2-4 employees and contractors (i.e., Clinical Assistants, Clinical Research Associates, Clinical Specialists, Monitors, etc.)
  • Develop and Finalize ICFs, protocols/amendments, IB, site budget/CTA and contribute to IND filings
  • Oversight and project management of individual studies as well as relevant program related activities with minimal supervision including managing team meetings (Agendas, Minutes, Action Items, Follow Up)
  • Assist in development of study plans, including vendor oversight, risk, safety, communication
  • Provide supervision, coaching and mentoring, and contribute to hiring new staff
  • Proactively identify risks, develop, and implement mitigation strategies
  • Oversee other clinical studies/goals in the future as determined by the company
  • Other assignments may be added in the future
Required Education
  • Bachelor’s degree, RN or equivalent
Desired Experience
  • Minimum of 5-10 years of experience in clinical research; oncology experience preferred
  • Experience as a Clinical Trial Manager preferred but strong Sr/CRA looking to take a step up is possible with the right fit
  • Experience in clinical trials and clinical data analysis with the ability to manage large databases and maintain paper and electronic documents
  • 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 high degree of accuracy and exactitude; ability to successfully lead and complete projects with multiple stakeholders
  • Excellent interpersonal, analytical, leadership skills
  • Highly proficient with Microsoft Office applications (Outlook, Word, Excel and PowerPoint)
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.

Additional Details

This is an in-house position 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 of time 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

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 3 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.

Our innovative therapy platform, RenovoTAMPTM, is designed to deliver well-established chemotherapeutic agents for localized treatment of solid cancer tumors with the aim of increasing patient survival and improving quality of life. RenovoRx has secured FDA Orphan Drug Designation for two indications pancreatic cancer and cholangiocarcinoma (bile duct cancer) which gives us 7 years of market exclusivity applied post-FDA approval. Our goal as a company is to leverage RenovoTAMPTM to develop a robust pipeline of targeted therapeutics to provide enhanced treatments for patients with solid tumors.

As a newly public company with a dedicated and close-knit team, we are working hard to execute on RenovoRx’s mission and are looking for an entrepreneurial, intellectually curious, and detail-oriented Associate/Director of Clinical Research to join our team.  You are a cross-functional connector, an architect and a problem-solver who is always willing to get into the weeds for the betterment of the team, our patients, and our mission. You are a people-oriented leader who leads with empathy and humility. While we are still a small company, our passion and commitment to developing effective and targeted cancer treatments is significant.

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) as well as 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 who 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) in accordance with 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 in a timely manner, 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
  • Other assignments may be added in the future

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 2/3 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 high degree of accuracy and exactitude; ability to successfully lead and complete projects with multiple stakeholders
  • Excellent interpersonal, analytical, leadership skills
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), snacks in the office, and paid holidays, vacation, and sick time. An Employee Referral program is offered to thank employees who refer top notch colleagues to the RenovoRx team. 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.

Additional Details

This is an in-house position based in Los Altos, California but may require travel to clinical sites. The role will require the ability to sit for extended periods of time 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.