Poseida is seeking an outstanding candidate to join our Clinical team. The Senior Director, Clinical Operations is accountable for the leadership, strategic planning, oversight, execution of clinical operations and the management of staff responsible for our cell therapy and gene therapy products. The individual must have the ability to work independently and also as an effective and engaged team member in a dynamic, fast-paced environment.
These may include but are not limited to:
- Build out and oversee the Clinical Operations function, processes and all activities related to execution of clinical studies and programs in accordance with regulatory guidelines
- Develop efficient, scalable system approaches to planning and implementing clinical trial operations that effectively integrate clinical operations and other functional areas
- Recruit, motivate and provide oversight for all in-house clinical operations and external department staff and resources associated within clinical operations, CRO’s and vendors
- Direct the successful execution of all clinical trials, programs, timelines and clinical milestones
- Oversight of Clinical Program Leaders for interdisciplinary project teams to ensure the successful execution of clinical programs and clinical operations
- Identify and resolve clinical operations issues related to data management, monitoring, timelines, drug distribution, safety assessment, regulatory compliance, and timely review of trial master files, etc.
- Manage all budgets, contracts, agreements, vendor payments and processes to conduct clinical trial programs in an effective manner.
- Oversee data collection activities for all clinical programs: CRF, SAE assessment, queries, and follow-up, annual reports, investigator brochures, BLA, etc.
- Perform other duties as assigned.
Requirements, Knowledge, Skills and Abilities
- BS in a scientific discipline with 10+ years of Clinical Operations line management experience (an equivalent combination of education and experience may be considered). MS, PharmD or PhD is preferred.
- Extensive background in oncology pharmaceutical and biotech clinical research and development. Experience with CAR-T clinical programs is highly desirable
- Proven history of strategic drug development, demonstrated through comprehensive clinical trial design and execution and prior regulatory accomplishments (NDAs/INDs).
- Proven experience hiring, leading clinical operations teams and overseeing their career growth skills
- Experience managing a rapidly changing organization and integrating new personnel is essential, as well as, ability to evaluate and resolve complex problems
- Demonstrated experience in CRO and vendor management to support global clinical trials, including excellent senior leadership, project management, budgeting, and negotiation skills, required
- Strong knowledge of FDA/EMEA regulations and GCP/ICH guidelines regarding clinical trial management.
- Excellent verbal and written communication skills and ability to relay vision/strong sense of department organization, processes, and change to management and staff
- Travel may be required up to 15%.
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.