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Ed/vp, Cmc Project Management

4 months ago

Brighton, United States Aura Biosciences Full time

**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**:
**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