At Aura Biosciences, we are developing a new class of therapies based on virus-like particles (VLPs) to target and destroy cancer cells selectively, while leaving surrounding tissue unharmed. By safely eliminating cancer locally, we can treat early and transform the lives of people with a wide range of cancers that are not optimally managed today.
Our lead program in choroidal melanoma is designed to selectively kill cancer cells in the choroid and our expectation is that this product will be utilized as a first-line therapy, as the existing radiotherapy treatment options have a large number of side effects. Aura is expanding its targeted therapy to other oncology indications and is currently initiating a program in bladder cancer. Come be a contributing team member in the development of a first-in-class treatment to selectively destroy cancer cells!
Role & Responsibilities:
This position will provide clinical trial management for ongoing and future clinical trials in either our lead program in ocular melanoma or our newest program in bladder cancer. Candidate will function as the Clinical Trial Lead with primary oversight on at least one trial that is managed in-house by the Aura Clinical Team. Partnering closely with the cross-functional stakeholders (Clinical, Regulatory, Quality, and Product Development), candidate will apply strong clinical and project management fundamentals for the implementation of all aspects of our clinical trial conduct.
- Reporting to the Associate Director, Clinical Operations, the Clinical Trial Manager will be responsible for managing all aspects of clinical trial conduct with subject matter experts including clinical development, contract vendors, quality and regulatory to achieve clinical trial goals on time and within budget.
- Develop clinical trial documents including informed consent templates, source documents, and Study Procedure Manual contents.
- Collaborate with Data Management Vendor to develop eCRF and completion guidelines as well as conduct user acceptance testing prior to release.
- Manage various clinical trial processes including all study start up activities, negotiating site budgets/contracts, investigator payments, protocol compliance reporting, central IRB reporting, and investigational product management.
- Provide oversight and management of regional Clinical Research Associates (CRAs) including review of site visit reports, oversight of quality metrics, and training records.
- Oversee data entry timelines and query management, including metric reporting.
- Conduct periodic clinical review of data entered into the Electronic Data Capture (EDC) system.
- Oversee investigative site and CRA adherence to SOPs, Good Clinical Practice and FDA regulations.
- Oversee vendor management of the Trial Master File (TMF) and ensure contents current.
- Facilitate and manage productive team communication and collaboration, both internally and externally.
The ideal candidate will offer:
- A minimum of a bachelor’s degree in the life sciences
- 3-5 years of direct and progressive experience specific to biopharma clinical trial management with a track record of successful management of complex programs using multiple external vendors
- Experience in oncology required and experience in ophthalmology highly preferred
- Experience with Microsoft office programs and web-based data entry platforms
- A passion for learning, creating, relating, communicating, and helping drive the success of cross functional teams
Based in the Company’s West Cambridge (Alewife) office, with travel as required to support Site Qualification and Site Initiation Visits. Remote-based candidates will be considered.
How we Work:
Aura is powered by a passion for bringing together diverse people, ideas and technologies behind common purpose: to create breakthroughs in diseases with significant unmet medical needs. We constantly seek opportunities to broaden our impact and reach, using new platforms and technologies, and partnering to ensure that our drug development expertise reaches its full therapeutic potential.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.
Email a cover letter and a copy of your CV to HR@aurabiosciences.com referencing the position description in the subject line.