InstilBio Inc, a cell therapy company focused on solid tumors, has recently acquired Immetacyte Ltd. InstilBio is developing patient specific immunotherapies in oncology, allowing the patient’s own immune system to be harnessed to fight cancer. The world-renowned team and its scientific advisors/investors have tremendous experience and track record in technology discovery, process development, GMP manufacturing and clinical operations with a track record of developing and gaining approval for successful cell therapies.
We have built upon the expertise of researchers who have successfully undertaken scientific and clinical research alongside Professor Robert Hawkins. Professor Hawkins is a leader in the field having undertaken several complex research projects and clinical trials involving: TIL, CAR-T, TCR based T cell therapies, cell selection, gene therapy, expansion of patient derived cells.
Recent significant investments in InstilBio are enabling the company to undertake Phase 2/3 to registrational clinical trials in melanoma. Further trials are planned in other solid tumor indications and using gene-modified approaches to build a pipeline of TIL-based therapies.
TIL Lead, Clinical Operations
Instil Bio is seeking a driven and experienced TIL Lead. The successful candidate will be able to demonstrate and apply both theoretical and practical knowledge and skills as they relate to clinical trial subject enrollment and TIL Journey oversight. They must also be able to work collaboratively with cross functional teams both internal and external to the Clinical Operations team.
The candidates must be knowledgeable of GCP, clinical trials, and biomedical shipping requirements. This role will comprise multiple critical functions:
- TIL Journey Management
- Subject Enrollment
- Chain of Identity & Chain of Custody Oversight
- Slot Manufacturing Scheduling
- Global Shipping Logistics
- Clinical Vendor Management
- Forms & Documents
- Product Complaints
- Site Initiation Visits & Dry Runs
In this role, the TIL Lead will be expected to oversee all aspects of clinical logistics for one or more clinical trials. They will be responsible for maintaining chain of identity (COI) and chain of custody (COC) for each clinical subject throughout the entirety of the TIL journey. They will be expected to manage all components of shipping logistics for each subject to and from Instil Bio manufacturing. The role will also require the TIL lead to ensure that GCP requirements are being adhered to at all times in any of the clinical logistics processes.
This position will routinely interact with TIL Recovery Specialists, Clinical Study Teams, Medical Monitors, Manufacturing, Quality Assurance, Supply Chain, Clinical Site Staff (Clinical Research Coordinators, Principal Investigators, Investigational Product (IP) Receipt Staff) and Vendors (Couriers, Suppliers). This position will report to the TIL Logistics Coordinator, Manager, within the Clinical Drug Supply, Logistics, Recovery function of the Clinical Operations department.
Responsibilities (include but not limited to):
- Serves as a primary and back-up liaison and clinical trial resource for the screening and enrollment of clinical trial participants across all assigned clinical studies.
- Must maintain adequate training standards and participate in routine refresher training on logistics process.
- Proactively communicates with clinical site research staff, vendors, and manufacturing to schedule and coordinate the TIL journey activities, as well as initiation/completion of study treatment and subsequent patient visits.
- Coordinates all aspects of subject tumor tissue collection and TIL journey including shipping, processing, manufacturing, and return of IP back to the clinical trial sites.
- Communicates with Clinical Recovery team on updates/statues of TIL recovery process.
- Communicates study requirements while ensuring adherence to the TIL journey process.
- Operationally supports the Clinical Recovery team during Dry Run preparation.
- Performs dry runs with clinical site staff to activate and prepare sites for subject enrollment.
- Works with contract research organizations (CRO) to communicate detailed timelines and ensure that performance expectations are being met.
- Participates in and provides TIL logistics updates at meetings as assigned.
- Leads internal team meetings and provides training as necessary at investigator meetings and other clinical trial-specific meetings.
- Manages the refinement and improvement of TIL logistics processes, including the screening/enrollment of trial patients, manufacturing scheduling, and follow-up process.
- Proactively identifies potential TIL logistics process issues/risks and recommends/implements solutions.
- Creates and manages programs as assigned, programs of which pertain to the TIL journey and COI/COC oversight.
- Supports cross functional projects.
- Provides oversight of TIL logistics training.
- Participates in the development, review, and implementation of departmental SOPs and processes.
- May assist with low-level management responsibilities as assigned.
- Assists department with audit and inspection readiness.
- Prepares and presents metrics and updates for management as assigned.
- Attends external/internal cross-functional meetings as assigned.
- Takes detailed meeting minutes as required.
- Participates in 24/7 on-call response program.
- May be required to work outside of normal business hours in support of clinical trial enrollment and TIL journey oversight.
- May be required to travel.
Requirements and Recommendations:
- BS or BA in a relevant scientific discipline with 5+ years of work experience in clinical trials, supply chain or logistics, organ recovery coordination, or related fields preferred
- An ideal candidate will possess all the following:
- Knowledge of clinical trials and logistics, and can assist project teams with this knowledge.
- Knowledge of FDA & ICH requirements as they pertain to clinical trials.
- Knowledge of domestic and international logistics/transport of biologic material (IATA, ICAO, ADR, DOT, WHO).
- Strong project management skills.
- Outstanding organizational skills with the ability to multi-task and prioritize.
- Excellent interpersonal, written, and verbal communication skills to support internal/external education, presentations, training in support of clinical operations and clinical trials.
- Ability to demonstrate strong analytical and problem-solving skills.
- Technical Skills:
- Experience with and ability to work with multiple database and electronic systems as it relates to the trial.
- Microsoft Office Suite proficiency