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.
Position Summary:
Reporting to the Chief Technology Officer, the ED/VP of CMC Project Management is responsible for all program management activities within the CMC organization, including the development and monitoring of CMC strategy plans, timelines and budgets, and acting as the subject matter expert (SME). The incumbent will utilize program management standard methodologies while partnering with CMC functional leads to further develop and manage the integrated CMC project plan. The ED/VP of CMC Program Management will provide project management expertise to ensure CMC activities are executed in coordination with and support of the integrated product development plan for late clinical-stage programs at Aura Biosciences.
Responsibilities include but are not limited to:
- Develop and execute the pre-BLA CMC strategy by working in collaboration with cross-functional teams and leading operational planning and implementation of CMC program plans
- Integrate clinical, regulatory, and commercial timelines into CMC strategy
- Facilitate internal CMC decision-making processes and preparing regular updates for senior management and other key stakeholders
- Manage external vendors and tech transfers to enable efficient and effective manufacturing, testing, stability, storage and logistics, CMC regulatory documentation preparation & review, and other related CMC operations
- Oversight of external CMOs, including alliance management, supply chain activities, budgets and proposals; coordinate internal program timelines and priorities with external CMOs
- Maintain program-related CMC specific documentation, including, but not limited to, program plans, timelines, risks, budget, and inventory
- Manage “requests for information” and prepare progress reports and ad hoc reports as required; coordinate compilation of data and implement best practices assuring project timelines are met
- Proactively identify knowledge gaps and risks, and work with teams to develop mitigation plans
Minimum Requirements:
- Bachelor’s or master’s degree in a scientific discipline required, PhD or MBA preferred
- 10+ years of relevant project/program management experience in BioPharma industry
- Deep understanding of pharmaceutical drug development; in-depth knowledge of CMC functions, including analytical development & stability programs, clinical trial materials, GMP manufacturing, quality & regulatory requirements
- Inspiring leadership capable of influencing across boundaries, motivate large teams, build collaboration, keep people accountable and drive for results in a versatile matrix environment
- Strong oral and written communication skills with ability to set priorities, resolve conflicts, and deliver effective presentation to stakeholders
- Experience in planning systems and tools (MS Project, Excel, Gantt, etc.)
- Ability to accomplish projects by deadline in a dynamic environment