(Sr.) Medical Director, Oncology

Aura Biosciences•Boston, MA

4d•Onsite

About The Position

Aura Biosciences is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors that aim to preserve organ function. Our lead candidate, bel-sar (AU-011), is currently in late-stage development for primary choroidal melanoma and in early-stage development in other ocular oncology indications and bladder cancer. Aura Biosciences is headquartered in Boston, MA. Our mission is to grow as an innovative global oncology company that positively transforms the lives of the lives of patients.

Requirements

MD with Board Certification, Board Certification in Oncology required.
5+ years of clinical experience post-training, including approximately 3+ years of experience in biotech/pharma/industry clinical development
Strong experience in industry Research & Development, with experience across early- and late-phase oncology clinical development (Phase 1–3).
Proven ability to strategize, prioritize and manage multiple projects simultaneously to ensure quality, timely, on target and within budget of accomplished tasks.
Attention to detail while discriminating between critical and non-critical activities and to follow established processes when identifying areas process improvement.
This person will have an entrepreneurial approach and have a ‘roll up your sleeves and get it done’ approach that is critical in biotech.
Highly developed ethics and integrity, with demonstrated ethical medical decision-making skills.
Excellent planning, time management, and organizational skills.

Responsibilities

Provide significant input on clinical development plans, trial designs, clinical trial execution, medical governance and monitoring in the Urologic Oncology TA.
Serve as Medical Lead/Medical Monitor for assigned clinical trials/programs, including responsibility for patient eligibility review, safety signal assessment, and ongoing medical oversight of trial conduct. Ensure support of operational trial execution across Clinical Operations, Regulatory Affairs, Data Management, Statistics, and other cross-functional teams.
Contribute to clinical decision-making including cohort expansion, dose evaluation, and emerging safety/efficacy signal interpretation.
Accountable for ethical conduct of studies in the Oncology/Oncology therapeutic area.
Assist in preparation of clinical sections of regulatory documents (INDs, IND annual reports, briefing packages, etc.); collaboratively prepare for meetings with FDA.
Stay current with GCP and regulatory requirements in the preparation and review of the clinical submission in the US and EU for drug and device. Champion clinical excellence in the therapeutic area.
Manage and maintain strong effective relationship with key external stakeholders and partners, key opinion leaders, investigators, consultants, patient advocacy groups as well as external clinical trial participants to demonstrate the primary goals of clinical development in all programs.
Support design and execution of investigator meetings and participate in site visits with Clinical trial investigators when needed.
Explore opportunities for simplification, ensuring that the therapeutic area is as effective and efficient as possible.