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 Manager of Preclinical Operations & Program Coordination directs the operational execution of HistoSonics’ new-application preclinical portfolio, overseeing the flow of studies, contract research organizations (CROs), key opinion leader (KOL) engagements, and cross-functional deliverables across multiple concurrent indication programs. Reporting to the Director of Translational Medicine & New Applications, this role keeps programs on schedule and on scope by managing the execution of in vivo, ex vivo, and in vitro studies, owning CRO milestones and contracting status, leading KOL and lab activities, and ensuring that regulatory, clinical, and marketing functions receive the right inputs at the right time. The Manager also provides clinical, procedural, and translational context in cross-functional settings, supports physician education and medical affairs activities, and partners closely with the Preclinical Program Coordinator, who handles day-to-day tracking and logistics. This is a multidisciplinary role at the center of the preclinical program for a candidate who combines clinical insight with strong program management and follow-through.
Key Responsibilities (What you’ll do):
- Program leadership & coordination: Own the operational health of concurrent preclinical programs - setting master timelines, prioritizing across competing programs, anticipating dependency and schedule risks, and keeping studies, CROs, and internal stakeholders synchronized. Partner with the Preclinical Program Coordinator on tracking and logistics; review and act on CRO status, study progress, and indication-readiness trackers as decision-support tools.
- Study execution support: Coordinate the planning and execution of preclinical studies - including proof of concept, effectiveness, safety, and biocompatibility (e.g., ISO 10993) testing - by managing logistics, documentation, scheduling, and deliverable tracking against development, regulatory, and clinical program requirements. Assist with protocol preparation, data collation, and study report turnaround.
- CRO & vendor management: Manage day-to-day relationships and project execution with external partners, including CROs, from proof of concept through GLP confirmatory studies. Coordinate Statement of Work (SOW) execution under existing Master Service Agreements (MSAs), track contracting status, monitor budgets and pass-through costs, and serve as the operational liaison for study kickoffs, progress check-ins, and deliverable acceptance.
- KOL & lab coordination: Organize and support engagement with internal and external subject matter experts across applications and specialties. Coordinate KOL meeting logistics, prepare briefing materials and leave-behinds, capture meeting notes and follow-ups, and help plan and run training events and labs (centers of excellence, MD training programs), and develop and deliver clinical training and educational content for physicians, advanced practice providers, and internal teams.
- Cross-functional collaboration: Work closely with research and advanced development (RAD), product and new application development, upstream marketing, risk management, clinical, regulatory, and operations to ensure program progression and execution of key tasks and milestones - ensuring regulatory and clinical affairs functions have all required R&D deliverables and documentation on schedule.
- Clinical context & team meeting participation: Attend and actively contribute to cross-functional team meetings, providing clinical context and translational perspective on the projects under discussion. Help connect study design, indication rationale, and clinical relevance for non-clinical stakeholders, ensuring decisions are grounded in the clinical realities of each application area and surfacing clinical considerations that may affect program direction.
- Procedural & imaging expertise: Provide hands-on procedural and image-guidance expertise (e.g., ultrasound, CT, fluoroscopy) during animal labs, cadaver labs, and feasibility studies. Advise on procedural technique, peri-procedural care considerations, and clinical workflow; provide end-user feedback to RAD and product development teams; and contribute clinical input to risk management activities (e.g., use-related hazards and adverse event context).
- Regulatory & clinical affairs support: Provide operational and documentation support for pilot/pivotal animal labs and for regulatory and clinical submissions, including GLP, Q-Sub, IDE, 510(k), De Novo, and/or PMA filings. Help assemble preclinical evidence packages and support feasibility and market-access study and protocol development, including clinical input on patient selection, peri-procedural care, and safety considerations.
- Clinical & marketing support: Contribute to clinical landscape synthesis, indication rationale materials, and KOL/advisory network mapping (including leveraging professional society relationships to identify and engage clinical experts), and support upstream marketing with indication-readiness inputs and program status as needed.
- Medical affairs & scientific exchange: Support scientific exchange with clinicians and KOLs, contribute to medical education materials and scientific presentations, and help communicate preclinical and clinical evidence accurately to internal and external audiences.
Qualifications and Skills:
- Education: Degree in a relevant scientific, biomedical, engineering, or clinical field. A clinical/medical background and active license (e.g., RN, NP, PA, MD, or equivalent) is strongly preferred. Candidates with strong preclinical or program management experience and an appropriate scientific degree will also be considered.
- Experience: Demonstrated experience in preclinical and/or clinical research and development, study coordination, or program/project management, preferably in medical devices or a regulated therapeutic environment. Experience coordinating CRO-conducted studies is strongly preferred.
- Program management: Proven ability to manage multiple concurrent projects, maintain detailed timelines and trackers, anticipate dependencies, and drive tasks to completion across distributed teams and external partners.
- Technical knowledge: Working knowledge of preclinical science and study conduct, including in vivo/ex vivo/in vitro methods, GLP and non-GLP study frameworks, and standards such as ISO 10993. Familiarity with the medical device product development and risk management process is preferred.
- Clinical & procedural expertise: Hands-on experience in image-guided, interventional, or surgical procedures (e.g., interventional radiology, vascular, or cardiothoracic surgery) is strongly preferred. Experience in clinical education, protocol development, quality improvement, or professional society leadership, and medical affairs credentials (e.g., BCMAS), are a plus.
- Regulatory familiarity: Exposure to regulatory submission support (Q-Sub, IDE, 510(k), De Novo, PMA) and to contracting structures (MSA/SOW) is advantageous.
- Communication & organization: Excellent organizational, written, and cross-functional communication skills; strong attention to detail; and the ability to keep stakeholders aligned and informed in a fast-moving, multi-program environment.
Minimum Qualifications:
- 3–5+ years of experience in industry, med tech, preclinical/clinical research, or program coordination, or equivalent clinical/procedural experience in a relevant specialty.
- Experience supporting or coordinating studies across one or more indication/application areas (e.g.,oncology, urology, neurosciences, vascular, cardiac, general surgery, women’s health, or metabolic and degenerative diseases).
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.