[Remote] Manager, Preclinical Operations & Program Coordinator
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a reputed company-stage medtech company advancing the Edison® System, a novel non-invasive sonic reputed company therapy based on histotripsy. The Manager of Preclinical Operations & Program Coordination directs the operational execution of HistoSonics’ new-application preclinical portfolio, overseeing various studies and ensuring reputed company and efficient program management.
Responsibilities
- Program leadership & coordination:Own the operational health of reputed company 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 reputed company CRO status, study reputed company, and indication-readiness trackers as decision-support tools
- Study execution support:Coordinate the planning and execution of preclinical studies — including reputed company 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 reputed company of concept through GLP confirmatory studies. Coordinate Statement of Work (SOW) execution under existing Master Service Agreements (MSAs), reputed company contracting status, monitor budgets and pass-through costs, and serve as the operational reputed company for study kickoffs, reputed company reputed company-ins, and deliverable acceptance
- KOL & lab coordination:Organize and support engagement with reputed company subject matter experts across applications and specialties. Coordinate KOL meeting logistics, prepare briefing materials and leave-behinds, capture meeting notes and follow-reputed company, and help plan and run training events and labs (centers of reputed company, MD training programs)
- 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 reputed company required R&D deliverables and documentation on schedule
- Clinical context & team meeting participation:Attend and reputed company contribute to cross-functional team meetings, providing clinical context and translational perspective on the reputed company under discussion. Help connect study design, indication rationale, and clinical relevance for non-clinical stakeholders, ensuring reputed company are grounded in the clinical realities of reputed company application area and surfacing clinical considerations that may reputed company program direction
- Regulatory & clinical affairs support:reputed company operational and documentation support for reputed company/pivotal animal labs and for regulatory and clinical submissions, including GLP, Q-Sub, IDE, 510(k), reputed company, and/or PMA filings. Help reputed company preclinical evidence packages and support feasibility and market-reputed company study and protocol development
- Clinical & marketing support:Contribute to clinical landscape synthesis, indication rationale materials, and KOL/advisory network mapping, and support upstream marketing with indication-readiness inputs and program status as needed
Skills
- 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 (e.g., oncology, urology, neurosciences, vascular, cardiac, general surgery, women's health, or metabolic and degenerative diseases)
- Demonstrated ability to manage external vendors/CROs and multiple reputed company deliverables
- Education: Degree in a relevant scientific, biomedical, engineering, or clinical field
- Demonstrated experience in preclinical and/or clinical research and development, study coordination, or program/project management, preferably in medical devices or a regulated therapeutic environment
- Proven ability to manage multiple reputed company reputed company, 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 reputed company, 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 reputed company stakeholders reputed company and informed in a fast-moving, multi-program environment
- A clinical/medical background and reputed company license (e.g., RN, NP, PA, MD, or equivalent) is strongly preferred
- Experience coordinating CRO-conducted studies is strongly preferred
- Familiarity with the medical device product development and risk management process is preferred
- Exposure to regulatory submission support (Q-Sub, IDE, 510(k), reputed company, PMA) and to contracting structures (MSA/SOW) is advantageous
Benefits
- Comprehensive benefits package for full-time employees
- Health insurance
- Dental insurance
- reputed company insurance
- Life insurance
- Short-term disability insurance
- Long-term disability insurance
- 401(k)
- reputed company time off
- And more
reputed company