About Aura:

Aura Biosciences is a clinical stage oncology company. We are developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively, while activating the immune system to create long lasting anti-tumor immunity.

We have a goal of developing this technology in multiple cancer indications, focusing initially on two therapeutic areas – ocular oncology and bladder cancer – with a goal to expand into other areas of solid tumor oncology. Initially we have focused our clinical development in the medical field of ocular oncology, a group of rare diseases that have no drugs approved. We are in Phase 3 with our lead VDC AU-011 in choroidal melanoma.  We are also in development in non-muscle invasive and muscle invasive bladder cancer, currently in a Phase 1 trial. 

We have commenced a global Phase 3 program investigating the delivery of AU-011 for the treatment of small choroidal melanoma and indeterminate lesions.  AU-011 has to date demonstrated an excellent efficacy and safety profile in Phase 2 for choroidal melanoma, and enrolment is ongoing in the pivotal Phase 3 trial.

Roles & Responsibilities:
Reporting to the Monitoring Oversight, CDO Manager this role will be responsible for managing investigational devices and ancillary supplies for assigned clinical studies and sites, in coordination with Clinical Operations, Device, Regulatory, Quality, and Finance teams.  This role will also closely collaborate with R&D Functions to oversee key suppliers and vendors needed to effectively enroll and support each clinical trial.

The position includes the responsibility for external clinical trial inventory management and distribution to ensure timely delivery of investigational devices and supplies to clinical sites.  This includes demand planning management, budgeting, cost and resource planning, ensuring timely delivery of site documentation, surveillance, and cost control.  This position will ensure full GCP compliance and documentation for medical device and related clinical supply activities.

Provide oversight of investigational medical devices used for our global clinical research programs. Serving as clinical operations management representative to internal team members and clinical trial site staff. This role requires good judgment and strong initiative with the ability to effectively prioritize and manage a diversified workload, often to strict deadlines.

Essential functions:

• Collaboration: participate as a member of cross-functional project team and/or sub-teams
• Establish Preferred suppliers to leverage purchasing power for clinical studies and other R&D categories and continually evaluate their effectiveness and performance.
• Manage and support RFI and RFP processes, including bid comparison, analysis, negotiation, and project award
• Support preparation of study documents from a medical device clinical trial management perspective including protocols, procedure manuals, Investigator brochure, informed consent forms, monitoring plan, and device installation records.
• Responsible & accountable for on-time distribution of devices and related clinical supplies to US and worldwide clinical sites
• Responsible & accountable for coordinating shipments and working with freight forwarders in the US and worldwide and ensuring timely delivery of study medical devices, materials and equipment
• Responsible for reconciliation of investigational hardware devices at end of study and ancillary clinical trial materials.
• Ensure that all supplies are controlled and distributed in accordance with GMP, GCP and GDP regulations
• Lead discussions with device vendors and the Clinical CRO on investigational device supplies, replenishments, returns and destructions.
• Manage invoicing against approved purchase orders and budgets.
• Communications: Ensures clear written communication to clinical sites and project team members through monitoring reports, follow up letters, study memos, and general correspondence. Thorough documentation and proper escalation of issues is essential in all visit reports
• Training: Ensures all site personnel training documentation is appropriately and prepared to conduct the clinical study in accordance with the clinical protocol and Instructions for Use. Monitor and maintain site personnel list, qualification, and training records
• Site compliance: Ensures any identified non-compliance issues are addressed, clearly communicated, documented, and escalated as requires through monitoring visits, analyzing study metrics, and general study data overview. Support regulatory inspection activities as required
• Event reporting: Ensures that all reportable events are identified, clearly documented and reported per protocol and as per applicable requirements and regulations.
• Author or respond to clinical sections of Regulatory dossiers and briefing packages
• Responsible for device clinical Project Management to plan, execute and monitor study timelines and track progress
• Lead and participate in process improvement initiatives
• Conduct practices in alignment with relevant ICH, ISO and GCP guidelines/regulations and SOPs

Qualifications:

• Project management skills and experience as a sub-team leader preferred.
• Excellent verbal and written ability
• Ability to interact across functional areas, gain cooperation of others and to provide direction and leadership
• Ability to manage and prioritize competing priorities
• Creative problem solver with strong conflict resolution and leadership skills and ability to build and maintain strong relationships in a hybrid (in-person and remote) team environment
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. Requires the ability to change the thinking of or gain acceptance of others in sensitive situations
• Minimum of a BS or equivalent, in Chemistry, Biology, Engineering, or Electronics.
• Minimum of 3 years medical device experience and 5 years clinical trial experience
• Strong computer and computer network skills
• Strong technical writing skills
• Must be an effective communicator with strong analytical skills to work with both internal and external Ph.D. scientists and senior management
• Ability to travel up to 20% of the time globally
• Knowledge of Quality Assurance Programs and requirements, statistical methods and computer literacy required
• Strong interpersonal, people, and problem-solving skills and strong clinical site interaction skills

Salary & Benefit Information

Salary Range: $100,000/yr – $140,000/yr

(Placement within the listed range depends on many factors including, but not limited to: geographic location, degree, years of experience, and internal company equity.)

• Health insurance with FULL premium coverage
• 401K with company match
• Employee Stock Purchase Program (ESPP)
• Competitive Paid time off (PTO)
• Company-paid short & long-term disability insurance and life insurance