Calyxo, Inc.

Manager

• Support program coordination and execution through planning, logistics, and execution of HCP educational programs, peer‑to‑peer events, and hands‑on trainings.
• Assist with field and faculty communication, and post‑program follow‑up activities.
• Coordinate program materials, content, equipment, venue logistics, and customer travel (as needed).
• Support faculty onboarding and prepare faculty to facilitate Calyxo messaging.
• Assist with program reporting, tracking attendance, budget monitoring, and documentation.
• Support peer-to-peer events and activities including regional speaking engagements, virtual consultations/webinars, and Calyxo Direct Events at society meetings.
• Assist with management of speaker logistics, contracts, and payment processing.
• Maintain and update faculty rosters and records.
• Provide administrative and logistical support for engagement activities, including meetings, advisory boards, and ongoing communication.
• Assist with drafting and processing speaker agreements, honoraria, and expense documentation.
• Develop, foster and maintain relationships with KOLs in the endourology field.
• Work closely with Marketing, Sales, Commercial Acceleration, and Clinical/Medical Affairs to ensure alignment and smooth execution of all professional education activities.
• Assist in collecting and organizing program feedback, metrics, and performance insights for continuous improvement.
• Support execution of virtual education initiatives, including webinar setup, invitations, and backend technical coordination.
• Perform on-going needs assessments in partnership with Sr. Manager to ensure professional education initiatives contribute and align with commercial priorities.
• Participate in society meetings, forums, symposia, educational and scientific programming meetings for promoting product & procedural awareness and guideline development as needed.
• Maintain program documentation, calendars, and tracking tools.
• Assist with compliance processes, including speaker contracting, needs assessments, documentation requirements, and invoicing.
• Manage inventory for professional education programs.

Professional Education Manager

• Serve as the primary technical owner for sterility assurance, biocompatibility, and environmental & microbial monitoring programs, including overall program development, management, maintenance, and execution.
• Oversee compliance and continuous improvement of sterility assurance and biocompatibility processes, testing strategies, execution, and documentation.
• Provide hands‑on technical leadership and execution over programs including bioburden, sterility, endotoxin, and EO residuals.
• Lead execution and review of EO sterilization validations, re-qualifications, and repeatability studies with external sterilization service providers.
• Serve as the primary interface to sterilization, biocompatibility, and microbiology suppliers and laboratories, driving schedules, deliverables, and issue resolution.
• Execution of testing, validation, and documentation activities within functional scope.
• Subject-matter expert and decision authority within functional scope.
• Accountable/responsible for issue resolution impacting compliance & supply continuity within functional scope.
• Support manufacturing transfers, alternate site qualifications, and supplier changes from a sterility and microbiology perspective.
• Partner closely with R&D, Operations, Quality and Regulatory in execution against aggressive timelines and resolving urgent issues as they arise related to functional areas.
• Support R&D, Operations, Quality and Regulatory with sterility, biocompatibility, and microbiology related technical assessments and risk evaluations as needed.
• Author, review, and approve sterility, biocompatibility, and microbiology related protocols, reports, rationales, and technical documentation.
• Ensure compliance with applicable standards and regulations including ISO 14937, ISO 11135, ISO 11737, ISO 10993, and FDA QMSR.
• Support regulatory submissions, inspections, and audit activities related to functional areas
• Provide mentoring and technical guidance to the organization and cross-functional team members.

Biocompatibility and Sterility Assurance Manager

• This leadership role within Medical and Clinical Affairs is responsible for strategic management of Scientific Affairs activities including scientific communications, publication and podium planning, KOL engagement and pre-clinical evidence generation.
• The role requires cross-functional collaboration with Clinical Operations, Marketing, R&D, Sales, and Regulatory to drive impactful outcomes.
• The ideal candidate will have a deep understanding of scientific research and clinical development and will oversee medical writing, as well as biostatistical support for all scientific affairs research engagements.
• This position requires strong communication skills and the ability to lead and support a fast-paced, dynamic team.

Professional Education Manager

Biocompatibility and Sterility Assurance Manager

Manager, Scientific Affairs