[Hiring] Manager, Preclinical Operations & Program Coordination @HistoSonics, Inc.

Role Description

The Manager of Preclinical Operations & Program Coordination directs the operational execution of HistoSonics’ new-application preclinical portfolio, overseeing the flow of studies, contract research organizations (CROs), key opinion leader (KOL) engagements, and cross-functional deliverables across multiple concurrent indication programs. This role keeps programs on schedule and on scope by managing the execution of in vivo, ex vivo, and in vitro studies, owning CRO milestones and contracting status, leading KOL and lab activities, and ensuring that regulatory, clinical, and marketing functions receive the right inputs at the right time.

Key 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.
• Study execution support: Coordinate the planning and execution of preclinical studies — including proof of concept, effectiveness, safety, and biocompatibility testing.
• CRO & vendor management: Manage day-to-day relationships and project execution with external partners, including CROs.
• KOL & lab coordination: Organize and support engagement with internal and external subject matter experts across applications and specialties.
• Cross-functional collaboration: Work closely with various teams to ensure program progression and execution of key tasks and milestones.
• Clinical context & team meeting participation: Attend and actively contribute to cross-functional team meetings, providing clinical context and translational perspective.
• Procedural & imaging expertise: Provide hands-on procedural and image-guidance expertise during animal labs, cadaver labs, and feasibility studies.
• Regulatory & clinical affairs support: Provide operational and documentation support for pilot/pivotal animal labs and for regulatory and clinical submissions.
• Clinical & marketing support: Contribute to clinical landscape synthesis, indication rationale materials, and KOL/advisory network mapping.
• Medical affairs & scientific exchange: Support scientific exchange with clinicians and KOLs, contribute to medical education materials and scientific presentations.

Qualifications

• Degree in a relevant scientific, biomedical, engineering, or clinical field.
• A clinical/medical background and active license (e.g., RN, NP, PA, MD, or equivalent) is strongly preferred.
• 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.
• Working knowledge of preclinical science and study conduct, including in vivo/ex vivo/in vitro methods.
• Hands-on experience in image-guided, interventional, or surgical procedures is strongly preferred.
• Exposure to regulatory submission support and to contracting structures is advantageous.
• Excellent organizational, written, and cross-functional communication skills.

Requirements

• 3–5+ years of experience in industry, med tech, preclinical/clinical research, or program coordination.
• Experience supporting or coordinating studies across one or more indication/application areas.

Benefits

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

Company Description

HistoSonics is a commercial-stage medtech company advancing the Edison® System, a novel non-invasive sonic beam therapy based on histotripsy. The company has progressed beyond initial market entry into commercial expansion, reimbursement momentum, and ongoing clinical and pipeline development.