Senior Manager, Patient Support Operations
Sana Biotechnology, Inc.
4 months ago
Remote friendly (Cambridge, MA)
United States
Operations
Responsibilities:
- Own and manage clinical operational chain of custody for drug products (clinical trial site logistics, documentation, and receipt protocols).
- Partner with Technical Operations and Clinical Development on hand-off procedures from manufacturing to clinical operations.
- Serve as primary site-facing single point of contact to ensure sites are prepared for receipt, handling, and surgical implantation; identify and drive gap closure.
- Provide real-time operational support and technical guidance with surgical/transplant teams during dosing/transplant; triage and escalate time-critical risks.
- Coordinate execution to meet program timelines and quality standards; track milestones, surface risks early, and drive resolution with clear owners.
- Onboard and manage clinical sites (readiness assessments, capability evaluations, performance monitoring, corrective actions).
- Develop and maintain site-level patient operations and surgical logistics playbooks; support remote/on-site monitoring, training, documentation, and coordination.
- Oversee site conduct for protocol compliance, patient safety, data integrity, and accurate documentation.
- Support SOP/Work Instruction development; collaborate on CTMS and TMF maintenance; may support PM tasks, audits, and other duties.
Qualifications:
- Bachelor’s in life sciences or RN; significant transplant/cell therapy operations experience may substitute.
- 8+ years in clinical development operations or CRA roles with transplant, apheresis, or cell therapy studies; direct cell therapy/transplant experience; surgical experience a plus.
- Hospital/clinical setting proficiency; strong logistics and regulated chain-of-custody compliance.
- Strong communication, quality/detail orientation, and organizational/time-management skills.
Preferred:
- First-in-human cell therapy “Site Concierge”/onsite sponsor representative experience.
- FACT/JACIE and ISBT knowledge; cell therapy instrumentation expertise.
What you should know:
- Domestic travel ~25–40%; work in sterile hospital environment with gowning/safety protocols.
- Base pay range: $160,000–$200,000/year (varies by factors).
- Own and manage clinical operational chain of custody for drug products (clinical trial site logistics, documentation, and receipt protocols).
- Partner with Technical Operations and Clinical Development on hand-off procedures from manufacturing to clinical operations.
- Serve as primary site-facing single point of contact to ensure sites are prepared for receipt, handling, and surgical implantation; identify and drive gap closure.
- Provide real-time operational support and technical guidance with surgical/transplant teams during dosing/transplant; triage and escalate time-critical risks.
- Coordinate execution to meet program timelines and quality standards; track milestones, surface risks early, and drive resolution with clear owners.
- Onboard and manage clinical sites (readiness assessments, capability evaluations, performance monitoring, corrective actions).
- Develop and maintain site-level patient operations and surgical logistics playbooks; support remote/on-site monitoring, training, documentation, and coordination.
- Oversee site conduct for protocol compliance, patient safety, data integrity, and accurate documentation.
- Support SOP/Work Instruction development; collaborate on CTMS and TMF maintenance; may support PM tasks, audits, and other duties.
Qualifications:
- Bachelor’s in life sciences or RN; significant transplant/cell therapy operations experience may substitute.
- 8+ years in clinical development operations or CRA roles with transplant, apheresis, or cell therapy studies; direct cell therapy/transplant experience; surgical experience a plus.
- Hospital/clinical setting proficiency; strong logistics and regulated chain-of-custody compliance.
- Strong communication, quality/detail orientation, and organizational/time-management skills.
Preferred:
- First-in-human cell therapy “Site Concierge”/onsite sponsor representative experience.
- FACT/JACIE and ISBT knowledge; cell therapy instrumentation expertise.
What you should know:
- Domestic travel ~25–40%; work in sterile hospital environment with gowning/safety protocols.
- Base pay range: $160,000–$200,000/year (varies by factors).