Manager, Medical Device Project Management

About Aura:

At Aura, our mission is to develop a new class of oncology targeted therapies that deliver meaningful therapeutic benefit to a range of cancer indications with high unmet need in which we believe we can establish a new standard of care. We are driven by our passion and commitment to science and the patients battling cancer who are relying on us to pioneer these new therapies.

We are focusing the initial development of our VDC technology platform to treat tumors of high unmet need in ocular and urologic oncology. AU-011, our first VDC candidate, is being developed for the first line treatment of primary choroidal melanoma, a rare disease with no drugs approved. Beyond primary choroidal melanoma, we are developing AU-011 in additional ocular oncology indications, including choroidal metastases. Leveraging our VDCs’ broad tumor targeting capabilities, we also plan to initiate a clinical program in non-muscle invasive bladder cancer, or NMIBC, our first non-ophthalmic solid tumor indication.

Position Summary:

Reporting to the VP of Device Development and Innovation, the Manager, Medical Device Project Management role will be responsible for managing investigational devices and projects related to clinical studies and device development programs, in coordination with Clinical Operations, Device, Regulatory, Quality, and Finance teams.

The position includes the responsibility for external clinical trial investigational medical device inventory management and distribution to ensure timely delivery of investigational devices to clinical sites.  This includes demand planning management, project 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 medical devices used for our global clinical research programs. Serving as clinical device 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.

Responsibilities:

• Responsible for medical device clinical Project Management to plan, execute and monitor study timelines and track progress
• Participate as a member of cross-functional project team and/or sub-teams
• Support preparation of study documents from a medical device clinical trial management perspective including protocols, procedure manuals, Investigator brochure, and device installation records.
• Responsible for development of Technical Information and Customer Information Bulletins
• Responsible & accountable for on-time distribution, installation and training of investigational medical devices to US and worldwide clinical sites
• Responsible for reconciliation of investigational medical devices at end of study.
• 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, and returns.
• Perform effective project management to ensure timely completion of activities and manage invoicing against approved purchase orders and budgets.
• Ensure completeness and accuracy of all medical device records and proper archiving such as in the trial history file or combination product design history file.
• Lead and participate in process improvement initiatives

Communication:

• Ensure clear written communication to clinical sites and project team members through monitoring reports, follow up letters, study memos, and general correspondence.
• Represents device department by preparing effective presentations, Gantt charts, taking meeting mins, etc. to report on status of medical device clinical activities at study sub team meetings.

Training:

• Ensures all site investigational medical device personnel training documentation is appropriately prepared to conduct the clinical study in accordance with the clinical protocol and Instructions for Use.
• Conduct practices in alignment with relevant ICH, ISO and GCP guidelines/regulations and SOPs

Preferred Requirements:

• Project management skills and experience as a sub-team leader preferred.
• Experience with managing investigational medical devices in a clinical trial
• 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

Key Requirements/Minimum Qualifications:

• Minimum of a BS or equivalent, in Chemistry, Biology, Engineering, or Electronics.
• Minimum of 3 years medical device 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, engineers and senior management
• Ability to travel approximately 5-10 % 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: $110,000/yr - $150,000/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

Salary : $110,000 - $150,000