Aura Biosciences

Manager

• Prepare and negotiate CDAs, MSAs, Consulting Agreements, CTAs and other agreements.
• Engage with Legal and support companywide contract review, negotiation, tracking and renewals, ensuring alignment with the procurement process.
• Support contract execution and ensure proper signature authority.
• Ensure proper maintenance of all executed agreements, including management of contract expirations by engaging stakeholders and preparing renewals when needed.
• Support Legal in assisting internal stakeholders with management of vendor relationships, compliance with contract terms and with the assessment of vendor performance.
• Work with CLO on projects as assigned.
• Seek support with external counsel as needed in connection with ongoing activities companywide.

Senior Contracts Manager

Director

• Collaborating on, or leading where appropriate, the preparation of clinical trial related documents including protocols, Investigator Brochure updates, charters, result presentations, and clinical sections of regulatory documents.
• Reviewing safety and efficacy data, data listings and preparing/ supporting data presentations.
• Support ongoing review, reconciliation, and quality control of clinical and efficacy data listings across active studies in close coordination with Data Management and Biostatistics.
• Rapid response to data or results questions from senior management.
• Participate in trial level activities for multiple trials including review of Clinical Operations documentation such as operational plans, data management plans, etc.
• Support safety/PV related activities including working with safety management vendor for safety monitoring and reporting activities.
• Support activities related to training of internal team, vendors, and site staff as required.
• Conduct literature reviews and contribute to competitive assessments for each therapeutic area.
• Collaborate on projects as necessary with other functions within Clinical as well as across project teams (Regulatory, Medical Writing, Medical Affairs, etc.).
• Proven ability to effectively support/contribute to multiple complex studies or projects.
• Adhere to SOPs, systems, and other process related training.

Director, Clinical Development Scientist – Urologic Oncology

Medical Director

• 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.

Senior Contracts Manager

Director, Clinical Development Scientist – Urologic Oncology

Senior Medical Director, Oncology