Manager, Preclinical Operations – Program Coordination

HistoSonics, Inc.

. Direct operational execution of HistoSonics’ new-application preclinical portfolio .

Posted 11/4/2026full-timeRemote • United StatesMid-LevelSenior💰 $150,000 - $170,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing preclinical and clinical research programs, including study coordination, regulatory submissions, and cross-functional collaboration. Proficient in operational execution, project management, and providing clinical training and support in medical device development.

Highest-signal resume keywords

Preclinical Research ManagementClinical Study CoordinationRegulatory Submission SupportCRO Relationship ManagementImage-Guided Procedure Expertise

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Study CoordinationProject ManagementData CollationProtocol PreparationIn Vivo MethodsIn Vitro MethodsGLP KnowledgeISO 10993 FamiliarityMedical Device DevelopmentRisk Management

Soft Skills

Organizational SkillsCross-Functional CommunicationAttention to Detail

Tools & Technologies

Master Service AgreementsStatement of WorkClinical Training MaterialsScientific Presentations

Certifications & Qualifications

Active Clinical License (RN, NP, PA, MD)

Industry Keywords

Med TechPreclinical ResearchClinical ResearchRegulatory FrameworksKOL Engagements

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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