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, to realize the broader potential histotripsy across multiple disease states and medical specialties.
We offer an exciting work culture where cutting-edge science meets real-world application, and each team member’s contribution is important to our success in ensuring our physicians and their patients get what they need most.
Location: Remote
Position Summary (Why this role matters):
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.
Key Responsibilities (What you’ll do):
- 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 & CROlogistics: Coordinate the day-to-daylogisticsof 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 andmaintainstudy 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,monitoringmilestones 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.
Qualifications and Skills:
- 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.
- Education: Clinical background as a licensed professionalrequired— for example, radiologic technologist, sonographer/ultrasound technologist, registered nurse (RN), orotherlicensed clinical/allied-health credential. An advanced degree is notrequired.
- Experience: Experience in medical device, med tech, or a regulated life-sciences industry environment, ina researchcoordination, clinical/preclinical research support, or project/program coordination capacity. Combination of clinical practice and industry experiencestronglypreferred.
- Organization & execution: Exceptional organizational skills, attention to detail, anda track recordof reliable task completion across multiple concurrent workstreams and deadlines.
- Tools: Comfort with project tracking, spreadsheets, and document management tools; ability to build andmaintainclear 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: We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
U.S. Work Authorization & Sponsorship: Employer will not sponsor visas for position.
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