Director, Data Management

Aura Biosciences • Brighton, MA

70d • $185,000 - $245,000

About The Position

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. 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.

Requirements

• 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 is required
• Creative, capable problem-solver with the necessary attention to details
• Experience leading teams supporting NDA and IND filings
• Demonstrated ability to establish and articulate a plan for a team to ensure appropriate focus and direction
• Adept at outsourcing and managing services provided by clinical data management vendors and contractors
• Strong analytical skills and demonstrated experience in gathering, interpreting, and analyzing data in clinical research and drug development
• Extensive experience interacting with regulatory agencies in GCP inspections/audits, both US and ex-US
• Proven strong leadership and project management skills with the ability to influence decisions and achieve results. Demonstrated ability in managing internal and external functional/multi-functional teams and/or initiatives
• Excellent interpersonal and communication skills, both verbal and written
• Flexible to changing priorities, detail-oriented, works well under pressure with an initiative to take on unfamiliar tasks
• Demonstrated ability to evaluate the business impact of decisions, follow through on agreed-upon decisions, and remain flexible when needed
• Excellent analytical, problem-solving, and organization skills with the ability to work on multiple tasks
• Ability to communicate technical information to non-scientists, and willingness to educate the internal team
• Strong team player with excellent collaboration skills

Responsibilities

• Provide clinical data management leadership to align on and drive data collection requirements to set a high-performance and collaborative culture.
• Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects.
• Responsible for end-to-end clinical data management activities providing data management representation and leadership on internal cross-functional teams, in addition to 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.
• Utilizes knowledge of data management processes to evaluate and recommend new technologies and systems for improved data management functionality.
• Holds accountability to resolve complex issues and proactively develop solutions, within the function and across functions. Leveraging technical/functional expertise to develop solutions. Using clear communications and collaborative strategies to drive to resolution.
• Manages the resource assignments ensuring appropriate support is in place to provide data quality oversight for clinical trials.

Benefits

• Salary Range: $185,000/yr - $245,000/yr
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Master's degree
• Number of Employees: 101-250 employees