Manager, Preclinical Operations – Program Coordination

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the operational implementation of HistoSonics’ preclinical portfolio for new applications.

• Take ownership of the operational health of multiple concurrent preclinical programs, which includes managing master timelines, prioritizing tasks, handling dependency management, and mitigating schedule risks.

• Organize and execute studies focused on proof-of-concept, effectiveness, safety, and biocompatibility.

• Handle logistics, documentation, scheduling, and tracking of deliverables for studies.

• Aid in the preparation of protocols, data compilation, and timely completion of study reports.

• Manage relationships with CROs and vendors from proof of concept to GLP confirmatory studies.

• Coordinate the execution of Statements of Work under Master Service Agreements, track contract statuses, monitor budgets and pass-through costs, and ensure deliverable acceptance.

• Organize engagements with Key Opinion Leaders (KOLs), including meeting logistics, briefing materials, note-taking, follow-ups, training events, and lab activities.

• Design and present 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 insights during cross-functional meetings.

• Offer hands-on procedural and image-guidance expertise during animal labs, cadaver labs, and feasibility studies.

• Provide advice on procedural techniques, peri-procedural care, clinical workflow, risk management, and end-user feedback.

• Support pilot and pivotal animal labs as well as regulatory and clinical submissions, including GLP, Q-Sub, IDE, 510(k), De Novo, and/or PMA filings.

• Assist in the assembly of preclinical evidence packages and support the development of feasibility and market-access studies and protocols.

• Contribute to the synthesis of the clinical landscape, indication rationale materials, KOL/advisory network mapping, medical education materials, and scientific presentations.

• Report directly to the Director of Translational Medicine & New Applications.

• Collaborate with the Preclinical Program Coordinator on daily tracking and logistical tasks.

⛳️ Requirements

• A degree in a relevant scientific, biomedical, engineering, or clinical discipline.

• 3–5+ years of experience in the industry, medical technology, preclinical/clinical research, or program coordination, or equivalent clinical/procedural experience in a relevant specialty.

• Experience in supporting or coordinating studies across one or more indication/application areas.

• Proven track record in preclinical and/or clinical research and development, study coordination, or program/project management.

• Strong preference for experience in coordinating studies conducted by CROs.

• Demonstrated capability to manage multiple concurrent projects, maintain detailed timelines and trackers, foresee dependencies, and drive tasks to completion.

• Working knowledge of preclinical science and study execution, including in vivo/ex vivo/in vitro methodologies.

• Familiarity with GLP and non-GLP study frameworks and ISO 10993.

• Preference for candidates with knowledge of medical device product development and risk management processes.

• Strong preference for hands-on experience in image-guided, interventional, or surgical procedures.

• Advantageous to have exposure to Q-Sub, IDE, 510(k), De Novo, and/or PMA regulatory submission support.

• Familiarity with MSA/SOW contracting structures is a plus.

• Excellent organizational, written, and cross-functional communication abilities.

• Strong attention to detail and capacity 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; the 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.