Senior Director managing execution of clinical trial programs to advance gene therapy. Leading clinical operations, ensuring strategic execution, and mentoring clinical teams across multiple clinical programs.
About the role
- Director of Data Management at Aura Biosciences leading clinical data management initiatives for drug development. Providing strategic leadership to drive data collection and quality across multiple projects.
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.
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.
Benefits
- 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
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