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.
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Manager, Financial Reporting and Accounting
RenovoRx (NASDAQ: RNXT) is a 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). Our goal as a company is to leverage RenovoTAMP to develop a robust pipeline of targeted therapeutics to provide enhanced treatments for patients with solid cancer tumors.
As a newly public company with a dedicated and close-knit team, we are working hard to execute on RenovoRx’s mission. We are excited to add a full-time finance professional to our team to help ensure timely and accurate financial reporting, while also bringing continued sound finance practices to the business. Based in Los Altos, CA, RenovoRx values a candidate who is ready to roll their sleeves up and be actively involved in day-to-day business operations that build to the Company’s financial reporting responsibilities. While we are still a small company, our passion and commitment to developing effective and targeted cancer treatments is significant.
The Manager, Financial Reporting and Accounting will be the boots on the ground Finance representative for our Los Altos office. You will report to our Controller and be responsible for assisting with day-to-day finance team operations.
- Financial Reporting (Forms 10-Q; 10-K and 8-K)
- Interfacing with Legal, the printer and others involved in the preparation of securities filings
- Prepare quarter and annual financial statement footnotes in accordance with US GAAP and SEC reporting requirements
- Review footnote support prepared by the corporate team and make additional inquiries of preparers and/or the business as necessary
- Perform US GAAP and SEC accounting research and assist in providing technical guidance regarding implementation of new accounting standards. Work with the Corporate Technical Accounting Group to gather and support information necessary to address new standards requirements. Assist with resolving technical accounting and disclosure issues as new accounting standards are implemented.
- Coordinate the monthly close process to include reviewing and approving journal entries, reconciliations, profit and loss analysis, payroll processing, including automation when applicable.
- Maintain and update the Company’s stock compensation records within the stock compensation software system.
- Prepare quarterly accounting, reporting, and analysis for the Company’s stock compensation plans. Manage the execution of specific financial reporting and share based compensation controls. Provide necessary financial reporting information to auditors and respond to auditor inquiries, as necessary.
- Assist the Company’s initiatives to implement more timely financial reporting requirements and improve quarter and annual close cycle times.
- Support internal controls over the financial reporting process to ensure compliance with SOX. Assist in the implementation and design of internal controls.
- Make recommendation for continuous process improvements to maximize efficiency in financial reporting and operations.
- Assist with annual budget process and quarterly forecasting
NOTE: This is an in-house position based in Los Altos, California.
- 4-6 years of experience in accounting (including public accounting)
- Public company experience required
- Experience with Sarbanes Oxley (SOX) and implementing controls
- Experience working with life sciences companies is desired
- Degree in Accounting or Finance
- Certified Public Accountant desired
- Detail-oriented with high degree of accuracy and exactitude
- Knowledge of US GAAP and SEC rules and regulations
- Knowledge of accounting systems, including third party cloud-based systems.
- Excellent interpersonal, analytical, leadership skills
- Ability to work effectively under strict time constraints
- Ability to successfully lead and complete projects with multiple stakeholders
- Ability to effectively interact with all levels of management and across functions
- Highly proficient with Microsoft Office applications (Word, Excel and PowerPoint)
We offer our team members a competitive compensation and benefits package, including an annual bonus opportunity, stock options, healthcare, and 401(k) (with match program).
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.
Clinical Trial Manager I
RenovoRx, (NASDAQ:RNXT) is an exciting biopharmaceutical company fighting cancer with a novel, logical therapy platform, currently in a Phase 3 registrational trial for its first indication: locally advanced pancreatic cancer. The Company’s therapy platform utilizes approved chemotherapeutics with validated mechanisms for delivery and well-established safety and side effect profiles, with the goal of increasing their efficacy, improving their safety, and widening their therapeutic window. RenovoRx has secured FDA Orphan Drug Designation for its first two indications: pancreatic cancer and bile duct cancer (cholangiocarcinoma). Previous studies have demonstrated a median overall survival of 27.9 months versus expected survival of 12-15 months in pancreatic cancer patients receiving only intravenous (IV) systemic chemotherapy. The Phase 3 trial is 44% enrolled as of August 15, 2021 and the Company plans to further build out the platform within the next several months.
RenovoRx is a growing and efficient team where the right candidate for this important position, based in Los Altos, CA, will be exposed to many aspects of the study and the business, generally unattainable in larger organizations. The Clinical Trial Manager I position has an opportunity to join a passionate team with the shared vision to make a major impact on the treatment of cancer patients in areas void of significant advancement.
The Clinical Trial Manager I will strive to support the management and execution of one or more clinical trials/programs and be a hands-on professional, who understands a fast-paced start-up environment and can support managing all aspects of clinical development. This will include managing the needs of RenovoRx’s current Phase 3 pancreatic cancer randomized trial, an upcoming Phase 2/3 bile duct cancer trial, and other upcoming oncology trials. Clinical Trial Manager I must be resourceful with excellent problem-solving skills and be able to assist in management with all operational aspects of clinical trial(s)/program(s) including site selection, startup, enrollment, maintenance, and close-out. Additionally, Clinical Trial Manager I will be attentive to detail and able to contribute to deliverables such as writing study protocols, informed consent forms, study manuals and development of SOPs.
Clinical Manager I Responsibilities
- Overall support in management of multi-center oncology trials conducted by the company, including:
- Become a subject matter expert on RenovoRx clinical trial protocols.
- Respond to questions from Clinical Sites regarding protocol and study conduct as they arise.
- Overseeing patient enrollment including 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, Data Management, Imaging, and others as necessary.
- Support coordination with Data Monitoring Committee/Data Safety Monitoring Board and organize regular meetings.
- Maintain Clinical Research Project status and support 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.
- Help manage CROs and third-party vendors to ensure delivery against contracted scope of work and budget.
- Participate in selection of CRO and vendors including development of RFPs, budget negotiations and management.
- Help 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 aspects of vendor oversight, risk, safety and communication.
- Assist to 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.
- Proficient in use of a PC.
- Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook).
- Knowledgeable of various EDC systems (i.e., MediData).
- Ability to use standard office equipment (scanner, copier, phones).
Conceptual Skills Requirements
- Ability to read, analyze, and interpret complex clinical data.
- Excellent communication skills, organization skills, and diligence.
- Excellent computer literacy skills.
- Efficiently prioritize multiple tasks and utilize time management.
- Ability to collaborate well with a small team and an independent initiative-taker.
- Ability to take responsibility and support managing multiple projects as well perform the entire spectrum of work as needed.
- Able to manage large databases and maintaining electronic documents.
- Ability to work well under pressure and time constraints for competing priorities.
- Well-developed focus, and teamwork skills.
- Smart, efficient, and even-tempered.
- Initiative-taking and able to thrive in a fast-paced, start-up environment.
- Energetic, forward-thinking, and creative.
- High ethical standard and appropriate professional image.
- Analytical ability, technical skills, good judgment, and project management experience.
- Possess the ability to see a larger picture perspective and is well versed in the different aspects of the company operation.
- Must have exceptional skills, including motivation and delegation.
- Bachelor’s Degree in life sciences, medicine, nursing, or other health related disciplines.
- Minimum of 2-6 years of experience in clinical research including oncology experience (sponsor or CRO).
- At least 2 years clinical trial management experience.
- Experience in clinical trials and understanding of clinical data analysis within the industry.
Physical and Mental Requirements
- Sit for extended periods of time using a computer or phone.
- Share a workspace and maintain good order.
- Lift up to 20 lbs.
- Ability to work independently or with others in a small office environment.
- Ability to travel to clinical sites equal or less than twenty percent of time.