Preclinical Program Manager

HistoSonics is a commercial-stage medtech company advancing the Edison® System, a novel non-invasive sonic beam therapy based on histotripsy. Since receiving FDA De Novo grant for the non-invasive destruction of liver tumors in 2023, the company has progressed beyond initial market entry into commercial expansion, reimbursement momentum, and ongoing clinical and pipeline development. In addition to its current liver tumor indication, HistoSonics is pursuing future indications across multiple applications including kidney, pancreas, prostate, neuro, women’s health, and other significant underserved human health areas.

About the role

The Preclinical Program Manager serves as the true “air traffic controller” for HistoSonics’ new-application preclinical studies — keeping the many moving parts of concurrent indication programs organized, on schedule, and visible to the team. Reporting to the Director of Translational Medicine & New Applications, this execution-focused role maintains master timelines and trackers, coordinates study and CRO logistics, manages documentation, and serves as the operational bridge between the New Applications team and other functions (regulatory, clinical, marketing, RAD, and operations). The ideal candidate is a licensed clinical professional with industry experience who is exceptionally organized and excels at task completion, follow-through, and keeping programs running smoothly behind the scenes.

Responsibilities

• Air-traffic control for studies: Serve as the central coordination point across concurrent preclinical studies — building and maintaining master timelines and living trackers (CRO status, study progress, contracting status, indication readiness), monitoring dependencies and milestones, and flagging schedule risks early to the Director and Manager so programs stay on track.
• Cross-team bridge: Act as the operational link between the New Applications team and other functions — regulatory, clinical affairs, upstream marketing, RAD, risk management, and operations — routing requests, tracking hand-offs, and ensuring deliverables and documentation move between teams on schedule.
• Study & CRO logistics: Coordinate the day-to-day logistics of in vivo, ex vivo, and in vitro studies and CRO-conducted work — scheduling, shipment and sample tracking, meeting coordination, action-item follow-up, and deliverable tracking from study kickoff through report delivery.
• Documentation & records: Organize and maintain study documentation, protocols, reports, SOW/contracting paperwork, and program files; ensure version control, completeness, and easy retrieval for regulatory, clinical, and audit needs.
• Contracting & vendor support: Support CRO and vendor coordination by tracking SOW execution status under existing Master Service Agreements, monitoring milestones and invoices/pass-through costs, and helping schedule check-ins — escalating issues to the Director and Manager.
• KOL & event logistics: Provide logistical support for KOL engagements and lab/training events — scheduling, travel and meeting coordination, preparation of materials, and capture of notes and follow-up items.
• Status reporting: Compile and circulate regular program status updates, meeting notes, and action-item lists, giving the Director, Manager, and broader team clear visibility into where each program stands.

Requirements

• 10-15 years of experience in industry (medical device, med tech, or regulated life sciences), including research coordination, clinical/preclinical research support, or project coordination.
• Active license as a clinical/allied-health professional (e.g., radiologic technologist, sonographer, RN, or equivalent).
• Demonstrated ability to manage multiple tasks, timelines, and stakeholders simultaneously with strong attention to detail.
• Comfort working in a fast-paced, multi-program environment and coordinating across internal teams and external vendors.

Qualifications

• Education: Clinical background as a licensed professional required — for example, radiologic technologist, sonographer/ultrasound technologist, registered nurse (RN), or other licensed clinical/allied-health credential. An advanced degree is not required.
• Experience: Experience in medical device, med tech, or a regulated life-sciences industry environment, in a research coordination, clinical/preclinical research support, or project/program coordination capacity. Combination of clinical practice and industry experience strongly preferred.
• Organization & execution: Exceptional organizational skills, attention to detail, and a track record of reliable task completion across multiple concurrent workstreams and deadlines.
• Tools: Comfort with project tracking, spreadsheets, and document management tools; ability to build and maintain clear trackers and timelines.
• Communication & coordination: Strong written and verbal communication and the ability to coordinate across teams and external partners, keeping stakeholders informed and aligned.
• Process awareness: Familiarity with GLP/non-GLP study frameworks, ISO 10993, or medical device development processes is a plus; willingness to learn these is essential.

Benefits

• Health, dental, and vision insurance
• Life, short-term and long-term disability insurance
• 401(k)
• Paid time off

U.S. Work Authorization & Sponsorship: Employer will not sponsor visas for this position.