Aura Biosciences

Aura Biosciences

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

Brighton, Massachusetts · Director

Sponsorship not specifiedDetected 33 days ago
GCPData AnalysisStatisticsProject ManagementHIPAAClinical TrialsClinical ResearchFDA RegulatoryMedical DevicesResearchExperimental DesignCommunicationPublic Speaking

About the role

  • 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.

Responsibilities

  • Support ongoing review, reconciliation, and quality control of clinical and efficacy data listings across active studies in close coordination with Data Management and Biostatistics.
  • Support safety/PV related activities including working with safety management vendor for safety monitoring and reporting activities.

Requirements

  • 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.
  • Knowledge of FDA regulatory guidelines, drug development process and ICH/GCP is required.

Nice to have

  • Reviewing safety and efficacy data, data listings and preparing/ supporting data presentations.
  • 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 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.
  • Adhere to SOPs, systems, and other process related training.
  • Skills and Experience
  • Bachelor's degree in life sciences field is required

Skills

  • Effective written and spoken communication skills are essential.
  • Strong project management skills and drive for excellence.

Compensation

  • $170,000/yr - $245,000/yr
  • 401K with company match

Benefits

  • Health insurance with FULL premium coverage
  • Employee Stock Purchase Program (ESPP)
  • Competitive paid time off (PTO)
  • Company-paid short & long-term disability insurance and life insurance
  • Collaborate on projects as necessary with other functions within Clinical as well as across project teams (Regulatory, Medical Writing, Medical Affairs, etc.).
  • (Placement within the listed range depends on many factors including, but not limited to: geographic location, degree, years of experience, and internal company equity)

Company info

  • 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 patients.
  • For more information, visit aurabiosciences.com.
  • Follow us on X (formerly Twitter) AuraBiosciences and visit us on LinkedIn.
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This listing is sourced directly from Aura Biosciences's careers page and normalized into a canonical job model.