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.
These may include but are not limited to:
- 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.
Requirements, Knowledge, Skills and Abilities
- 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.)
Who We Are and What We Do
Poseida is a San Diego based biotechnology leader in the development of cell and gene therapies. We have built a wholly-owned pipeline of autologous and allogeneic chimeric antigen receptor T cell, or CAR-T, product candidates, initially focused on the treatment of hematological malignancies and solid tumors. Here at Poseida we are constantly innovating and growing as we advance our CAR-T therapies in the clinic and our gene therapies currently under development. The Poseida team is passionate about the impact we are making in developing treatments, or even cures, for patients with cancer or other genetic diseases.
The company’s CAR-T product candidates are manufactured with Poseida’s non-viral piggyBac® DNA Modification System, resulting in a high percentage of stem cell memory T cells (TSCM). Tscm cells are the only T cells that are self-renewing and long-lived, potentially resulting in product candidates that are more efficacious, less toxic and more durable. Poseida is currently developing the following CAR-T product candidates:
- P-BCMA-101 is an autologous CAR-T therapy for the treatment of relapsed/refractory multiple myeloma, currently enrolling patients for a Phase 2 registrational trial with initial dosing expected in the first half of 2019.
- P-PSMA-101 is an autologous CAR-T product candidate targeting PSMA-specific cancer cells in castrate resistant prostate cancer, with filing of an IND anticipated in the second half of 2019.
- P-BCMA-ALLO1 is an allogeneic, or universal donor, CAR-T product candidate, manufactured using Poseida’s proprietary Cas-CLOVER™ site specific gene editing system and is being developed as a treatment for relapsed/refractory multiple myeloma, with an IND filing anticipated by late 2019 or early 2020.
- P-MUC1C-101 is an autologous CAR-T product candidate in late-stage preclinical development for numerous solid tumor indications, including ovarian, breast, lung, colorectal, pancreatic and renal cancers, with filing of an IND anticipated in 2020.
Poseida plans to broadly advance its current CAR-T programs and emerging pipeline programs, including gene therapies for orphan genetic diseases.
To apply send your resume and cover letter to email@example.com.