Director, Data Management
Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned and independently operated subsidiary of Bayer AG acquired in 2020, is a fully integrated AAV gene therapy company dedicated to developing life-saving medicines that have the potential to cure genetic diseases. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular and metabolic disease indications with a clinical-stage pipeline that includes therapeutics for Pompe disease, Parkinson’s disease and congestive heart failure, as well as out-licensed clinical indications for hemophilia and Duchenne muscular dystrophy. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, UK, the company has generated hundreds of proprietary third-generation AAV capsids and promoters, several of which have entered clinical testing. Founded in 2001 and an early innovator in the gene therapy field, the company holds more than 850 patents in areas such as AAV production and chimeric and self-complementary capsids. Learn more at www.askbio.com.
The Director, 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.
We are excited about our next Director, Data Management to join the AskBio team!
The Director, Data Management will:
- Provide 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.
- Effectively manage changes to database design and data management requirements as necessary due to protocol amendments and changes to overall clinical development programs.
- Support the development and implementation of innovative strategies and technologies for data management database programming ensuring capture and validation of all required trial data.
- Integrate technology seamlessly to allow for data re-use and operational efficiencies in both data management and statistics
- Provide technical guidance to DM staff and vendors around standards, practices, and specifications to ensure integrated data processing and computing solutions.
- Develop, troubleshoot, and maintain complex programs and utilities leading to database design, creation, validation, & use as well as clinical trial statistical analysis.
- Draw 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.
- Identify 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.
- Serve in 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, and providing status updates.
- Lead or participate in the development of departmental standard operating procedures, working procedures and guidance documents.
Required Education & Experience
- Bachelor’s degree with a minimum of 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.
Preferred Skills & Experience
- Thorough knowledge of CDASH® standards and how they support CDISC® standards (both SDTM & ADaM).
- Hands-on experience with confirming database design and DM principles are consistent with all types CDASH® of and their support of SDTM/ADaM.
- 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.