Clinical Lead (Contract)
About this role
CLINICAL LEAD (CONTRACT)
Company: Mitria Medical
Type: Contract
Term: January to June 2027 (about 6 months)
Hours: Full-time (about 40 hours per week)
Location: Toronto, Ontario - Hybrid
Reports to: Chief Executive Officer
ABOUT MITRIA MEDICAL
Mitria Medical, a T45 Labs portfolio company, is an early-stage structural heart company developing a next-generation transcatheter solution for mitral valve repair. Our team brings together physician inventors with T45 Labs’ product development, operations, and clinical and regulatory strategy expertise to advance the device toward broader clinical use.
ABOUT THE ROLE
As Mitria’s first Clinical Lead, you will own the clinical work for our compassionate use trials outside the US on a six-month contract. You will make sure every case produces data and records that FDA can accept, while meeting Canadian ethics rules, local approval requirements, and Good Clinical Practice (GCP). Reporting directly to the CEO, you will work autonomously, running the program day to day and making decisions independently within the plan and budget Mitria sets.
WHAT YOU WILL DO
• Own the compassionate use plan, case workflow, and timelines. • Coordinate each case from request to close-out, with the treating physician and site staff. • Run each case to FDA expectations so the data can support a US submission. This includes 21 CFR Parts 50 and 56 and, for devices, Part 812. • Prepare and track Research Ethics Board (REB) submissions, amendments, and approvals. • Confirm the local Canadian approvals each case needs, with Mitria regulatory advisors. • Collect and check informed consent, source documents, and case report forms. • Keep records and data systems that meet FDA expectations, including 21 CFR Part 11 where electronic records apply. • Track product shipment, receipt, use, return, and accountability at each site. • Report adverse events and device incidents to Mitria’s safety and quality leads within the required time limits. • Keep the trial master file ready for FDA inspection and audit. • Write or approve SOPs, forms, and templates for compassionate use cases. • Direct vendors and any CRO support, within budget limits that Mitria sets. • Advise Mitria leadership on clinical risk, the FDA pathway, and resourcing. • Send a short status report each week to Mitria leadership. • Write a handover plan and file all records, so a permanent lead can take over in July 2027.