Poseida Therapeutics, Inc. is seeking a talented Director, Data Management to join our team in San Diego, CA. This position offers an excellent opportunity for a highly motivated individual to contribute to innovative clinical trials for new CAR-T, gene editing and gene therapy products in an exciting and dynamic environment focused on cutting-edge gene editing technology. The Director, Data Management will responsible for leading and managing all data management activities related to the planning, execution, collection, and cleaning of clinical trial data. This position will have oversight of final delivery of data for clinical study reports, publications, and regulatory submissions. This role will be accountable for the oversight of outsourced data management activities and for managing internal staff and processes.
- Responsible for coordination/execution of all data management aspects of clinical studies, including study start-up, enrollment and follow up, and study closure activities.
- Serve as Lead Data Manager for multiple projects/trials and provide guidance to clinical trial and data review teams as applicable.
- Author and review applicable data management related documents including case report forms, data management plans, data transfer specifications, coding standards, line listing review plans, data validation plans, clinical study reports, and any other related documents.
- Coordinate contract vendors and Clinical Research Organization data management related activities to ensure all are conducted according to study plans, timelines, budgets, and relevant SOPs.
- Lead sponsor data review process. Oversee CRO activities to ensure timely management and resolution of data queries.
- Oversee all data management activities leading to the final delivery of a clean clinical database for the purpose of clinical study reports, publications, and regulatory submissions.
- Partner with VP to develop vision and growth plan for data management function and capabilities, including EDC and other clinical system strategies.
- Ensure that data management activities are aligned with business objectives and in compliance with FDA, GCP, and ICH requirements.
- Monitor clinical data quality and progress of trials with data collection providers; drive corrective actions as needed; ensure proper integration of third-party/non-CRF data as applicable.
- Contribute to data management outsourcing strategies and oversight of relationships with external vendors.
- Collaborate with programmers, biostatisticians, and CRO staff to create and validate database designs and edit check specifications.
- Provide oversight of data coding and safety reconciliation process.
- Oversee and coordinate transfer of clinical data between all vendors in a clinical trial.
- Assist in the preparation of and participate in Investigator Meetings (as applicable).
- Lead and/or participate in project team meetings and conference calls to review progress of ongoing clinical trials, including key performance indicators and quality metrics.
- BS/BA in Biological Sciences, Life Sciences, or healthcare required. MS or equivalent preferred.
- 10+ years’ data management experience in biotech, pharma, or CRO setting, including previous experience managing others.
- Experience managing clinical data from oncology clinical trials.
- Experience managing multiple myeloma trial data preferred.
- Experience managing chimeric antigen receptor cell (CAR-T) data preferred.
- Working knowledge of Good Clinical Practices (GCP), ICH, and US and international regulations.
- Ability to travel up to 10%.
- Ability to deliver results and execute on required activities individually and in a team setting.
- Organized and detail-oriented.
- Strong communication skills in a compact clinical team working with aggressive timelines.
- Advanced written, oral, and interpersonal communication skills, including proficient knowledge of medical terminology.
- Computer skills (MS Office products, word processing, spreadsheets, etc.)
Poseida Therapeutics is a clinical-stage biotechnology company leveraging proprietary next-generation non-viral, gene engineering technologies to create life-saving therapeutics for patients with high unmet medical need. The company is developing a wholly-owned pipeline of autologous and allogeneic CAR-T product candidates, initially focused on the treatment of hematological malignancies and solid tumors. Poseida’s product candidates are designed to address the limitations of other CAR-T therapies, including duration of response, the ability to treat solid tumors and safety concerns. P-BCMA-101 is Poseida’s lead CAR-T therapy currently in Phase 1 clinical development for the treatment of relapsed/refractory multiple myeloma. For more information please visit Poseida.com