Manager, Preclinical Operations – Program Coordinator

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HistoSonics, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2009

🏭 Manufacturing

🏥 Healthcare

🧬 Biotechnology

Manufacturing • Healthcare • Biotechnology

HistoSonics, Inc. is a pioneering medical technology company that has developed a non-invasive sonic beam therapy platform using a treatment called histotripsy. This innovative approach harnesses focused ultrasound to mechanically destroy targeted liver tumors at a sub-cellular level. HistoSonics is dedicated to advancing the science of histotripsy, aiming to provide transformative benefits for patients and physicians worldwide, particularly through its ongoing clinical trials and educational programs.

📋 Description

• 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). • 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. • 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. • Clinical & marketing support: Contribute to clinical landscape synthesis, indication rationale materials, and KOL/advisory network mapping, and support upstream marketing with indication-readiness inputs and program status as needed.

🎯 Requirements

• 3–5+ years of experience in industry, med tech, preclinical/clinical research, or program coordination. • 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). • Demonstrated ability to manage external vendors/CROs and multiple concurrent deliverables. • 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. • 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. • 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. • 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. • Exposure to regulatory submission support (Q-Sub, IDE, 510(k), De Novo, PMA) and to contracting structures (MSA/SOW) is advantageous. • 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.

🏖️ Benefits

• health, dental, and vision insurance • life, short-term and long-term disability insurance • 401(k) • paid time off • more