Poseida Therapeutics, Inc. is seeking a talented Senior/Clinical Trial Manager 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 Senior/Clinical Trial Manager will be accountable for the overall coordination and execution of clinical trial activities. This role is expected to manage and oversee all study-level vendor and site related activities and issues related to one or more clinical trials.
- Responsible for coordination/execution of all operational aspects of clinical studies, including study start-up, patient enrollment and follow up, and study closure activities. Develop and manage study budgets, timelines, and resource requirements. Manage all outsourced activities for assigned trials. Provide management level representation during audits.
- Prepare and update clinical protocols, informed consents, case report forms, clinical study reports, and other study-related documents in consultation with cross-functional project team members.
- May perform co-monitoring and oversight visits at participating sites, CROs, clinical labs, etc., to ensure compliance with the Investigational Plan and appropriate regulations, guidelines, and policies.
- Oversee investigational site startup activities, including the preparation and review of study documents (e.g., ICFs, CRFs, study manuals, study binders, etc.), reviewing/approving essential regulatory document packages, reviewing site changes to ICFs, facilitating completion of clinical study agreements and budgets, and shipment of clinical supplies.
- Conduct/supervise training of CRO staff, investigators, and site staff.
- Set-up and maintain (or supervise) accurate study status and accountability logs.
- Review data listings and tables. Partner with data management to ensure timely management and resolution of data queries.
- Oversee operations of clinical studies to ensure compliance with the study protocol, timeline and budget.
- Coordinate contract vendors and Clinical Research Organizations activities to ensure all are conducted according to study plans, timelines, budgets, and relevant SOPs.
- Partner with CRO to develop and revise study specific plans and detailed timelines, and ensure that transferred obligations and performance expectations are met.
- Assist with protocol, case report form, source document template development, internal SOP/guideline development, and final report preparation.
- Assist in the management and 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.
- BS/BA in Biological Sciences, Life Sciences, or healthcare required. MS or equivalent preferred.
- Clinical Research 5-7+ years’ experience in biotech, pharma, or CRO setting.
- Experience managing oncology clinical trials from protocol development to final report.
- Experience managing prostate cancer trials preferred.
- Experience managing chimeric antigen receptor cell (CAR-T) studies preferred.
- Working knowledge of Good Clinical Practice (GCP) and US and international regulations for clinical trials.
- Ability to travel up to 25%.
- 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