Note: The job is a remote job and is open to candidates in USA. HistoSonics, Inc. is hiring a Manager of Preclinical Operations & Program Coordination to lead operational execution across its new-application preclinical portfolio. The role coordinates studies, CROs, KOL engagements, and cross-functional deliverables while contributing clinical and procedural expertise, physician education, and medical affairs support.
Responsibilities
- 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), and develop and deliver clinical training and educational content for physicians, advanced practice providers, and internal teams
- 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
- Procedural & imaging expertise: Provide hands-on procedural and image-guidance expertise (e.g., ultrasound, CT, fluoroscopy) during animal labs, cadaver labs, and feasibility studies. Advise on procedural technique, peri-procedural care considerations, and clinical workflow; provide end-user feedback to RAD and product development teams; and contribute clinical input to risk management activities (e.g., use-related hazards and adverse event context)
- 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, including clinical input on patient selection, peri-procedural care, and safety considerations
- Clinical & marketing support:Contribute to clinical landscape synthesis, indication rationale materials, and KOL/advisory network mapping (including leveraging professional society relationships to identify and engage clinical experts), and support upstream marketing with indication-readiness inputs and program status as needed
- Medical affairs & scientific exchange: Support scientific exchange with clinicians and KOLs, contribute to medical education materials and scientific presentations, and help communicate preclinical and clinical evidence accurately to internal and external audiences
Skills
- Degree in a relevant scientific, biomedical, engineering, or clinical field
- 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
- 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
- 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
- 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 (e.g.,oncology, urology, neurosciences, vascular, cardiac, general surgery, women's health, or metabolic and degenerative diseases)
- A clinical/medical background and active license (e.g., RN, NP, PA, MD, or equivalent) is strongly preferred
- Preferably in medical devices or a regulated therapeutic environment
- Experience coordinating CRO-conducted studies is strongly preferred
- Familiarity with the medical device product development and risk management process is preferred
- Hands-on experience in image-guided, interventional, or surgical procedures (e.g., interventional radiology, vascular, or cardiothoracic surgery) is strongly preferred
- Experience in clinical education, protocol development, quality improvement, or professional society leadership, and medical affairs credentials (e.g., BCMAS), are a plus
- Exposure to regulatory submission support (Q-Sub, IDE, 510(k), De Novo, PMA) and to contracting structures (MSA/SOW) is advantageous
Benefits
- Remote work
- For full-time employees: health, dental, and vision insurance
- For full-time employees: life insurance
- For full-time employees: short-term and long-term disability insurance
- For full-time employees: 401(k)
- For full-time employees: paid time off
Company Overview