Manager, Preclinical Operations – Program Coordination

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $150k - $170k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

📋 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

• Direct operational execution of HistoSonics’ new-application preclinical portfolio • Own operational health of concurrent preclinical programs, including master timelines, prioritization, dependency management, and schedule-risk mitigation • Coordinate planning and execution of proof-of-concept, effectiveness, safety, and biocompatibility studies • Manage study logistics, documentation, scheduling, and deliverable tracking • Assist with protocol preparation, data collation, and study report turnaround • Manage CRO and vendor relationships from proof of concept through GLP confirmatory studies • Coordinate Statement of Work execution under Master Service Agreements, track contracting status, monitor budgets and pass-through costs, and manage deliverable acceptance • Organize KOL engagements, meeting logistics, briefing materials, notes, follow-ups, training events, and labs • Develop and deliver clinical training and educational content for physicians, advanced practice providers, and internal teams • Collaborate with research and advanced development, product and new application development, marketing, risk management, clinical, regulatory, and operations teams • Provide clinical context and translational perspective in cross-functional meetings • Provide hands-on procedural and image-guidance expertise during animal labs, cadaver labs, and feasibility studies • Advise on procedural technique, peri-procedural care, clinical workflow, risk management, and end-user feedback • Support pilot/pivotal animal labs and 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 • Contribute to clinical landscape synthesis, indication rationale materials, KOL/advisory network mapping, medical education materials, and scientific presentations • Report to the Director of Translational Medicine & New Applications • Partner with the Preclinical Program Coordinator on day-to-day tracking and logistics

🎯 Requirements

• Degree in a relevant scientific, biomedical, engineering, or clinical field • 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 • Demonstrated experience in preclinical and/or clinical research and development, study coordination, or program/project management • Experience coordinating CRO-conducted studies is strongly preferred • Proven ability to manage multiple concurrent projects, maintain detailed timelines and trackers, anticipate dependencies, and drive tasks to completion • Working knowledge of preclinical science and study conduct, including in vivo/ex vivo/in vitro methods • Knowledge of GLP and non-GLP study frameworks and ISO 10993 • Familiarity with medical device product development and risk management processes is preferred • Hands-on experience in image-guided, interventional, or surgical procedures is strongly preferred • Exposure to Q-Sub, IDE, 510(k), De Novo, and/or PMA regulatory submission support is advantageous • Familiarity with MSA/SOW contracting structures is advantageous • Excellent organizational, written, and cross-functional communication skills • Strong attention to detail and ability to keep stakeholders aligned and informed • Active clinical/medical license such as RN, NP, PA, MD, or equivalent is strongly preferred • Candidates must be authorized to work in the United States; employer will not sponsor visas

🏖️ Benefits

• Health, dental, and vision insurance • Life insurance • Short-term and long-term disability insurance • 401(k) • Paid time off • Comprehensive benefits package for full-time employees

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