Associate Director/Director Data Management
We are a gene therapy company changing lives with every genetic advancement.
Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that cure genetic diseases has never wavered.
As the only end-to-end gene therapy company in the industry, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.
We became a wholly owned, independently operated subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy Platform. Our global headquarters are in Research Triangle Park, North Carolina, a thriving biotechnology hub, and we maintain additional research and development operations in Scotland and France and gene therapy manufacturing in Spain.
We have an opportunity for an Associate Director/Director Data Management professional to join the AskBio team in our Durham, North Carolina, location and be part of our continued success!
About the role
The Associate Director/Director of Data Management provides oversight of all data management activities outsourced to external suppliers and/or conducted in house, including but not limited to database design specification development, database design programming, database User Acceptance Testing (UAT) and database deployment to research sites thereby ensuring the quality and integrity of all databases used in AskBio sponsored trials.
Responsibilities and accountabilities
- Provides oversight of all data management activities outsourced to external suppliers and/or conducted in house, including but not limited to database specification development, database design programming, database User Acceptance Testing (UAT) and database deployment to research sites
- Demonstrated ability to coordinate and oversee multiple ongoing projects; effectively realign resources to changes in business and work priorities
- Effectively manages changes to database design and data management requirements as necessary due to protocol amendments and changes to overall clinical development programs
- Supports the development and implementation of innovative strategies and technologies for data management database programming ensuring capture and validation of all required trial data
- Integrates technology seamlessly to allow for data re-use and operational efficiencies in both data management and statistics
- Provides technical guidance to DM staff and vendors around standards, practices, and specifications to ensure integrated data processing and computing solutions
- Develops, troubleshoots, and maintains complex programs and utilities leading to database design, creation, validation, & use as well as clinical trial statistical analysis
- Draws on experience with identification of challenges, inefficiencies or downstream impacts, identifying solutions, engagement of appropriate stakeholders, garnering of management support, and implementation of a roll out plan (i.e., procedural documents, training materials, and training) to minimize risk and maximize quality
- Identifies opportunities for increased efficiency and consistency and provides leadership and support to improvement initiatives. Delivers expertise to development teams with regard to driving standardization and formulating solutions to complex issues
- Plays a leadership role on cross-functional initiatives and capital projects providing business input into system/user requirements, risk assessments, process document authoring, validation script writing, execution, and approval, as well as development of training materials, providing status updates, and other duties
- Leads or participates in the development of departmental standard operating procedures, working procedures and guidance documents and assists with/leads the development of the DM department
- Conducts objective setting, performance check-ins, and year-end discussions in compliance with AskBio policies; aligns objectives, feedback and performance evaluation with Line Manager
- If a line manager, meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements
- Models acceptable behaviors and communication with stakeholders to ensure effective partnerships
- BS degree with a minimum of 5-7 years clinical trial related data management experience (degree desired in life sciences, statistics, biostatistics, mathematics, computer science, biotechnology)
- Prior use of and/or familiarity with clinical trial database packages such as IBM, Medrio, MedidataRAVE, Oracle InForm
- Thorough knowledge of CDISC® standards (both SDTM & ADaM) and hands on experience of confirming database design and DM principles are consistent with all types of SDTM/ADaM domains design, development and validation
- Experience with Statistical Programming and/or programming experience to produce data displays for data monitoring and review helpful but not required
- Significant knowledge of the drug development process, clinical trial methodology, data management & statistics and relevant regulatory requirements for drug approval
- Demonstrated ability to operate and lead in a matrix organization, building successful working relationships and effective stakeholder management in an environment that requires diverse educational and functional expertise
- Experience identifying and mitigating potential risks in the DM space; problem resolution skills to solve errors/inconsistencies found in data processing to reduce risk to data integrity and validity
- Excellent verbal and written communications skills; able to communicate proactively and effectively
Live an “AskLife™
We offer a competitive total rewards package. Are you our next great discovery?