Director, Data Management

About Aura

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.

Job Summary

We are looking to expand our Biometrics team with this newly created position of Director, Data Management. Reporting to the Head of Biometrics, this role is responsible for the strategic leadership of the clinical Data Management function supporting multiple drug development programs. This hands‑on position will manage operational aspects of data management supporting global drug development activities and will lead clinical data management initiatives across multiple therapeutic portfolios, as well as manage the selection and oversight of data management vendor partners.

The position requires a broad, comprehensive, and detailed knowledge of data management platforms and software, clinical trial databases, and the pharmaceutical drug development process. The successful candidate will provide leadership and guidance around clinical data management and will be responsible for supporting end‑to‑end data management activities, including the development and implementation of data standards based on CDASH/SDTM.

Location:

Waltham, MA.

Primary Responsibilities

• Provide clinical data management leadership to align on and drive data collection requirements to set a high‑performance and collaborative culture.

• Efficiently plan, coordinate, and deliver complete, high‑quality and reliable clinical trial data in a timely manner for assigned projects.

• Provide end‑to‑end clinical data management activities with representation and leadership on internal cross‑functional teams and regulatory agencies.

• Provide strong quality and project oversight over third‑party vendor data responsible for data management deliverables.

• Ensure quality processes for data management through subject‑matter ownership of SOPs, training, and internal and external inspection activities. Establish best‑in‑class processes and standards for the generation and reporting of data.

• Work collaboratively with internal and external team members to coordinate the planning and execution of day‑to‑day data management deliverables.

• Provide expertise and guidance to the Clinical Development team regarding CDASH and CDISC data standards.

• Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives.

• Oversee database status with respect to key performance indicators, metrics, and program level deliverables and timelines.

• Contribute to project resource planning, re‑forecasting, and program milestones.

• Utilize knowledge of data management processes to evaluate and recommend new technologies and systems for improved data management functionality.

• Resolve complex issues and proactively develop solutions within the function and across functions, leveraging technical/functional expertise and clear communication.

• Manage the resource assignments ensuring appropriate support is in place to provide data quality oversight for clinical trials.

Qualifications

• BA/BS degree in Computer Science, or a closely related scientific field required.

• Master’s or other advanced degree in related field highly preferred.

• 10+ years of clinical/statistical data management within the biotech/pharmaceutical industry.

• 3+ years of demonstrated leadership experience and career progression.

• Experience in the development and implementation of Clinical data management standards and procedures required.

• Creative, capable problem‑solver with the necessary attention to detail.

• Experience leading teams supporting NDA and IND filings.

• Demonstrated ability to establish and articulate a plan for a team to ensure appropriate focus and…