At Aura Biosciences, we are developing a new class of therapies based on a 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, with radiotherapy that has a large number of side effects. Come be a contributing team member in the development of a first-in-class treatment to selectively destroy cancer cells!
Role & Responsibilities:
Aura Biosciences is actively recruiting for an Associate Director/Director, Clinical Operations. The successful candidate will have significant experience in ophthalmology and/or oncology R&D, support the Clinical R&D leadership team, and support the head of Clinical Operations in leading the operational strategies and execution of Aura’s drug development programs.
The candidate will perform various duties including helping execute the operational directives of the drug development program, developing and managing clinical trial budgets and timelines, and mentoring and managing internal Clinical Operations team members and outsourced activity. Partnering closely with the cross-functional stakeholders (Clinical, Regulatory, Project Management, Quality, Product Development), candidate will apply strong clinical and project management fundamentals for the implementation and oversight of all aspects of our clinical operations activities.
- Reporting to the head of Clinical Operations, the Associate Director/Director will be responsible for assisting in the oversight of all aspects of clinical trial conduct with subject matter experts including clinical development, contract vendors, quality, and regulatory to achieve all clinical trial goals on time and within budget.
- In collaboration with the head of Clinical Operations, develop clinical trial budgets and work closely with Project Management and Finance in the management and forecasting of these budgets.
- Provide input and review clinical protocols, specifically the development of the Schedule of Assessments and other key operational details.
- Assist, along with head of Clinical Operations and Project Management, on global development planning and specific development plans for clinical programs as needed.
- Develop clinical trial documents including Clinical Trial Plans, Safety Management Plans, Pharmacy Manuals, informed consent templates, and other Study Procedure Manual contents.
- Assist in the review and preparation of Requests for Proposals, Master Service Agreements, and Vendor Work Orders.
- Support the Clinical Leadership Team in the preparation and review of key data/results.
- Provide oversight and management of Clinical Operations team members and oversee adherence to SOPs, Good Clinical Practice and FDA regulations.
- Collaborate with the Data Management Vendor to develop eCRF and completion guidelines as well as conduct user acceptance testing prior to release.
- Develop and oversee the implementation of clinical processes and procedures including site budgets, investigator payments, protocol compliance reporting, and investigational product management.
- Act as the primary liaison between Clinical and QA including overseeing individual Clinical Trial Manager (CTM) management of quality activities for their assigned programs and oversight monitoring, as needed.
- Conduct periodic clinical review of data entered in the Electronic Data Capture (EDC) system.
- Facilitate and manage productive team communication and collaboration, both internally and externally.
- Responsible for line management of selected CTMs and Clinical Trial Associates.
- Act as back-up to CTMs with clinical operations of programs, as needed (i.e., vacation coverage or periodic increases in workloads).
The ideal candidate will offer:
- A minimum of a bachelor’s degree in the life sciences.
- 5-8 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 ophthalmology and/or oncology highly preferred.
- Experience working with small companies in the start-up environment is a strong plus.
- Experience with Microsoft office programs and web-based data entry platforms.
- Well versed and current in GCP, ICH, FDA, EMA and other relevant regulations and guidance’s that govern clinical trial conduct.
- 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 < 20% travel required. 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.