(Assoc.) Director, Clinical Development Scientist-Urologic Oncology

Position Summary

Aura Biosciences, Inc. is expanding its Clinical Development team to support several early- and late-phase clinical assets. They are seeking a highly motivated and hands-on Associate Director/Director level Clinical Development Scientist to support the continued development of AU-011 in the treatment of ocular and urologic cancers.

Essential Functions And Duties

• 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.
• 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.
• 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.

Skills And Experience

• Bachelor's degree in life sciences field is required; advanced degree (MS/PhD/PharmD, MD, etc.) is strongly preferred.
• Minimum of 5-10 years relevant Pharma or Biotech clinical drug development experience (PhI-IV) in a Clinical Scientist role.
• Urology clinical development experience strongly preferred, Oncology required.
• Experience in development of clinical documents to support regulatory submissions (eg, IND), clinical protocol/IB development, medical writing, literature reviews, data reviews and other similar clinical development projects.
• Knowledge of and experience applying the principles of clinical research methodology, statistics, data analysis and interpretation.
• Proficiency in data review tools for data interpretation to both design/execute clinical trials and to extract data/prepare results for relevant clinical trials.
• Demonstrated evidence of writing clinical documents.
• Experience working with and managing third party vendors, such as CRO’s.
• Effective written and spoken communication skills are essential.
• Knowledge of FDA regulatory guidelines, drug development process and ICH/GCP is required.
• Knowledge of device global regulatory requirements such as 21 CFR 820, 21 CFR 4, 21 CFR 3.2, and ISO 13485 preferred.
• Strong project management skills and drive for excellence.
• Effective written and spoken communication is essential.

Salary & Benefit Information

Salary Range: $170,000/yr - $245,000/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