Senior Clinical Trial Manager, Patient Support Operations

About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who are passionate about delivering the possible to patients, and who lead with the desire to work on novel ideas.

As the Senior Manager, Patient Support Operations, you will report to the Head of Clinical Operations to serve as the primary "Patient and Site Navigator" for our Type 1 Diabetes (T1D) program. You will lead the operational orchestration of drug product movement once received at the clinical site. Your primary focus will be managing the chain of custody responsibilities from a clinical operations perspective, ensuring seamless logistics and receipt at the site, while providing expert support for successful surgical outcomes for our patients.

Additionally, you will be an integral part of the Clinical Development Operations team supporting the planning, execution, and management of clinical trials in accordance with regulatory requirements and industry best practices for Sana programs.

This is a builder-operator role: you will translate strategy into execution by standing up workflows, pressure-testing processes, and ensuring systems, teams, and partners are aligned and ready to deliver reliably at the clinical site level.

What you’ll do

• Own and manage the clinical operational chain of custody for drug products, with accountability for clinical trial sites, including clinical site logistics, documentation, and receipt protocols.
• Partner closely with Technical Operations and Clinical Development stakeholders to refine and finalize the hand-off procedures between manufacturing and clinical operations.
• Serve as the primary, site-facing, single point of contact accountable for ensuring sites are fully equipped and prepared for receipt, handling, and surgical implantation of cellular medicines; proactively identify gaps and drive closure.
• Collaborate with surgical and transplant teams in hospital settings to provide real-time operational support and technical guidance during dosing/transplant; lead issue triage and escalate time-critical risks to Clinical Operations leadership as needed.
• Coordinate between Technical Operations and clinical providers to ensure execution aligns to program timelines and quality standards; track milestones, surface risks early, and drive timely resolution with clear owners.
• Onboard and manage clinical sites, owning readiness assessments and capability evaluations for complex cell therapy procedures; monitor ongoing operational performance and implement corrective actions in partnership with stakeholders.
• Develop, maintain, and continuously improve specialized playbooks for site-level patient operations and surgical logistics, ensuring controlled documentation and consistent implementation across sites.
• Responsible for both remote and on-site monitoring, training, documentation, and coordination of site teams, schedules and operational details.
• Oversee clinical trial conduct at assigned sites to ensure protocol compliance, patient safety, data integrity, and accurate documentation
• Provide a single point of contact and operational guidance for the site, managing general triage of questions or issues that arise; handling communication pathways.
• Participate in regular study team meetings providing regular updates on site performance and execution.
• Support the cross functional teams at Sana across programs.
• Help develop consistent SOPs and Work Instructions to support development of clinical site training playbooks and guidelines for Sana product delivery.
• Collaborates with development, maintenance and training of the Clinical Trial Management System (CTMS) and Trial Master File (TMF).
• May be assigned Project Management, or other operational tasks working with Clinical Operations Leads.
• May participate in audits and associated meetings, including preparation at study sites as needed.
• Collaborate with study team members for project execution and perform additional duties and tasks as assigned.
• Strong background in supporting authorship of clinical protocols/manuals, patient facing documents, IRB submissions and informed consents.
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines.
• Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment.

What we’re looking for

• A bachelor’s degree in a life sciences field or a nursing degree (RN); however, significant professional experience in transplant or cell therapy operations may be considered in exchange for a specific degree.
• 8+ years of experience in clinical development operations or as a clinical research associate (CRA) with experience in transplant, apheresis, or cell therapy studies; direct experience working in the cell therapy or transplant space (e.g., former Transplant Nurse, Apheresis Nurse, or specialized Clinical Technician), with surgical experience a plus.
• Deep comfort and proficiency working within a hospital/clinical setting, including interacting with surgical staff and navigating clinical trial site logistics.
• Proven ability to manage complex clinical logistics and ensure compliance with regulated chain of custody requirements during site delivery.
• Strong communication skills with the ability to convey clear, concise technical outcomes to both internal teams and external clinical partners.
• Committed to quality with a proven track record of being thorough and detail-oriented in ensuring protocol adherence and data integrity.
• Excels in organizational and time management skills, enabling effective multitasking in fast-paced environments while managing priorities, organizing time efficiently, and solving complex problems.

What will separate you from the crowd

• Prior experience as an onsite representative of a sponsor or "Site Concierge" for a first-in-human cell therapy trial.
• Knowledge of FACT/JACIE and ISBT accreditation procedures as they relate to cellular products.
• Experience with specialized cell therapy instrumentation and best practices for handled-product delivery.

What you should know

• This role requires domestic travel to clinical trial sites, approximately 25–40% of the time, to ensure site readiness and provide in-suite surgical support.
• You must be comfortable working in a sterile hospital environment and adhering to clinical gowning and safety protocols.
• The base pay range for this position at commencement of employment is expected to be between $160,000 and $200,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.