Manager, Preclinical Operations & Program Coordination (Medtech)

Location: Remote in the US; U.S. work authorization required. Visa sponsorship is not available.

Salary: USD 150,000–170,000 annually.

Company

hirify.global is a commercial-stage medtech company developing the Edison® System, a non-invasive histotripsy therapy platform, and expanding into additional clinical indications.

What you will do

• Lead the operational execution of concurrent preclinical programs, including master timelines, dependencies, risks, trackers, and cross-functional milestones.
• Coordinate in vivo, ex vivo, and in vitro proof-of-concept, effectiveness, safety, biocompatibility, and GLP studies.
• Manage CRO and vendor execution, including SOWs under MSAs, contracting status, budgets, pass-through costs, kickoffs, progress reviews, and deliverable acceptance.
• Coordinate KOL engagements, expert meetings, training events, centers of excellence, MD training programs, and clinical education content.
• Collaborate with research, product development, marketing, risk management, clinical, regulatory, and operations teams to deliver required documentation and milestones.
• Provide clinical and procedural input during animal, cadaver, and feasibility labs, including ultrasound, CT, and fluoroscopy image guidance, and support regulatory submissions and scientific exchange.

Requirements

• Relevant degree in a scientific, biomedical, engineering, or clinical field.
• 3–5+ years of experience in industry, medtech, preclinical or clinical research, program coordination, or equivalent relevant clinical/procedural experience.
• Experience supporting or coordinating studies across at least one indication or application area, such as oncology, urology, neurosciences, vascular, cardiac, general surgery, women's health, or metabolic and degenerative diseases.
• Experience in preclinical or clinical R&D, study coordination, or program/project management; CRO-conducted study coordination is strongly preferred.
• 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 in vivo, ex vivo, and in vitro methods, GLP and non-GLP frameworks, and ISO 10993; familiarity with medical-device development and risk management is preferred.
• Strong organizational, written, cross-functional communication, attention-to-detail, and stakeholder-alignment skills.

Nice to have

• Clinical or medical background with an active license such as RN, NP, PA, MD, or equivalent.
• Hands-on image-guided, interventional, or surgical experience, including interventional radiology, vascular, or cardiothoracic surgery.
• Experience in clinical education, protocol development, quality improvement, professional-society leadership, or medical affairs credentials such as BCMAS.
• Exposure to Q-Sub, IDE, 510(k), De Novo, or PMA submission support and MSA/SOW contracting structures.

Culture & Benefits

• Full-time employment in a multidisciplinary, commercial-stage medtech environment combining science with clinical application.
• Health, dental, and vision insurance, life insurance, short- and long-term disability insurance, 401(k), and paid time off.
• Work is remote within the US.
• Equal opportunity workplace committed to diversity and non-discrimination.