Preclinical Program Manager

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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

• Coordinate concurrent preclinical studies by maintaining master timelines and living trackers • Monitor CRO status, study progress, contracting status, indication readiness, dependencies, milestones, and schedule risks • Coordinate operational handoffs between New Applications and regulatory, clinical affairs, marketing, RAD, risk management, and operations • Manage logistics for in vivo, ex vivo, and in vitro studies and CRO-conducted work • Coordinate scheduling, shipments, sample tracking, meetings, action items, and deliverables from study kickoff through report delivery • Organize and maintain study documentation, protocols, reports, SOW/contracting paperwork, and program files • Ensure version control, completeness, and retrieval of records for regulatory, clinical, and audit needs • Support CRO and vendor coordination by tracking SOW execution, milestones, invoices, and pass-through costs • Provide logistical support for KOL engagements and lab/training events • Compile and circulate program status updates, meeting notes, and action-item lists

🎯 Requirements

• 10–15 years of industry experience in medical device, medtech, or regulated life sciences • Experience in research coordination, clinical/preclinical research support, or project/program coordination • Active license as a clinical/allied-health professional, such as radiologic technologist, sonographer, RN, or equivalent • Ability to manage multiple tasks, timelines, and stakeholders simultaneously • Strong attention to detail and reliable task completion across concurrent workstreams and deadlines • Experience coordinating across internal teams and external vendors • Comfort with project tracking, spreadsheets, and document management tools • Ability to build and maintain clear trackers and timelines • Strong written and verbal communication skills • Familiarity with GLP/non-GLP study frameworks, ISO 10993, or medical-device development processes is a plus • Willingness to learn relevant study frameworks and processes • Employer will not sponsor visas for this position

🏖️ Benefits

• Health insurance • Dental insurance • Vision insurance • Life insurance • Short-term disability insurance • Long-term disability insurance • 401(k) • Paid time off • Comprehensive benefits package for full-time employees