Mid-level industry position
Clinical Biospecimen Manager
Poseida is seeking an outstanding candidate to join our Clinical Development team. The Clinical Biospecimen Manager will be responsible for developing specimen collection strategy, ensuring accurate laboratory specifications and provide visibility and control of clinical specimens globally. Tasks include sample tracking, retrieval, reconciliation, handling, validating, and storage of biological samples. Additional tasks include ensuring sample integrity and maintaining GCP/GLP compliance for biologic study samples.
ResponsibilitiesThese may include but are not limited to:
- Collaborate with the Clinical Study teams to develop biological sample management plans in concurrence with the Central Laboratory (as necessary).
- Review clinical study protocols and associated documents and service provider laboratory scope of work documents for sample handling details.
- Partner with the Clinical Study team and Translations Medicine to develop sample specimen collection strategy including but not limited to storage and management of biologic specimens (e.g., PK, PD, Genomics, Biomarkers, etc.).
- Collaborate with the Clinical Study team and Translational Medicine to ensure single internal point of contact regarding specimen tracking.
- Partner with the Clinical Study team regarding strategy for specimen data collection and discrepancy management (e.g., Data Transfer Plan with analytical laboratories).
- Manage sample discrepancies as identified by Clinical Study staff or Translational Medicine.
- Manage specimen sample tracking, handling, receiving, storage and inventory process.
- Liaise with Clinical Study teams to ensure proper shipment of specimens and respond to issues as needed.
- Maintain quality control, inventory and organization of specimen samples. Track consent as it relates to testing and analysis. Devise plans and implement a biospecimen repository to cater for clinical and exploratory needs.
- Assist with development and review of laboratory sample management plans and requisitions.
- Interface with laboratory personnel, specimen processing vendors and other vendors as needed.
- Coordinate incoming and outgoing clinical study supply shipments, as needed as they pertain to biological samples.
- Assist in the preparation of study-specific training materials.
- Attend and participate in clinical team meetings, and interact in a positive, professional manner.
- Communicates frequently with vendors to proactively address clinical study site needs regarding sample management.
- Identify and escalate issues appropriately.
- Submit approval to ship biological samples for analytical assays per study timelines.
- Review status of samples received and completeness of data and create reports for study teams when requested.
- Participate in and/or leads process improvement projects under the direction of manager
- Supports manager in providing projections for annual and long-term planning.
- Authors necessary SOPs and Process Documents.
- Trains news hires as necessary
Requirements, Knowledge, Skills and Abilities
- Bachelor’s degree in Biochemistry, Chemistry, Biology, Immunology, Medical Technology or related field with a minimum of 2-3 years Clinical Operations (Sample Management) including work experience in related laboratory procedures, or scientific related field and/or training (an equivalent combination of education and experience may be considered). Advanced degree preferred.
- Technical knowledge to maintain electronic files.
- Knowledge of clinical laboratory assays and specimen handling. Experience with LIMS and specimen management tools a plus.
- Knowledge of clinical trials process and biological sample management role in a study.
- Working knowledge of FDA & ICH/GCP/GLP regulations and guidelines.
- Excellent analytical and assessment skills.
- Excellent judgment and problem-solving skills.
- Demonstrated ability to develop and implement SOPs and Work Processes and Instructions.
- Demonstrated project and operational management experience (e.g., effectively managing relationships with key internal stakeholders as well as external collaborators).
- May require up to 10% travel.
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.