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

Aura Biosciences•Boston, MA

About The Position

Aura Biosciences, Inc. is currently expanding its Clinical Development team to support several early- and late-phase clinical assets and is searching for 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. Aura is developing AU-011 as a biologic/drug-led combination product. This individual will report directly to the VP, Clinical Development (Urologic Oncology) and will play a key role in supporting clinical trial execution, data review, and cross-functional coordination. This position will collaborate closely with senior clinical scientists and with Medical Directors; in ocular oncology, and non-ocular solid tumors, with an initial focus in urologic cancer. (Medical Directors retain responsibility for clinical strategy, medical monitoring, and patient-level decision-making).

Requirements

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.

Nice To Haves

advanced degree (MS/PhD/PharmD, MD, etc.) is strongly preferred.
Urology clinical development experience strongly preferred
Knowledge of device global regulatory requirements such as 21 CFR 820, 21 CFR 4, 21 CFR 3.2, and ISO 13485 preferred.

Responsibilities

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.