{"id":3650822,"url":"https://alion.io/job/s3-ventures-clinical-lead-contract","title":"Clinical Lead (Contract)","company":{"id":704992,"name":"S3 Ventures","domain":"s3vc.com","url":"https://alion.io/company/s3-ventures","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":true,"listed_via":null,"ats_vendor":"Workable","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"lead","employment_type":"contractor","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Toronto, Canada"],"countries":["CA"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"GCP","optional":false},{"name":"Good Clinical Practice","optional":false}],"status":"live","first_seen_at":"2026-11-02T00:00:00Z","employer_posted_date":"2026-11-02","last_verified_at":"2026-11-12T04:10:53Z","board_verified":true,"closed_at":null,"days_open":10,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":10},"description":"CLINICAL LEAD (CONTRACT)\nCompany: Mitria Medical\nType: Contract\nTerm: January to June 2027 (about 6 months)\nHours: Full-time (about 40 hours per week)\nLocation: Toronto, Ontario - Hybrid\nReports to: Chief Executive Officer\nABOUT MITRIA MEDICAL\nMitria 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.\nABOUT THE ROLE\nAs 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.\nWHAT YOU WILL DO\nOwn the compassionate use plan, case workflow, and timelines.\nCoordinate each case from request to close-out, with the treating physician and site staff.\nRun 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.\nPrepare and track Research Ethics Board (REB) submissions, amendments, and approvals.\nConfirm the local Canadian approvals each case needs, with Mitria regulatory advisors.\nCollect and check informed consent, source documents, and case report forms.\nKeep records and data systems that meet FDA expectations, including 21 CFR Part 11 where electronic records apply.\nTrack product shipment, receipt, use, return, and accountability at each site.\nReport adverse events and device incidents to Mitria’s safety and quality leads within the required time limits.\nKeep the trial master file ready for FDA inspection and audit.\nWrite or approve SOPs, forms, and templates for compassionate use cases.\nDirect vendors and any CRO support, within budget limits that Mitria sets.\nAdvise Mitria leadership on clinical risk, the FDA pathway, and resourcing.\nSend a short status report each week to Mitria leadership.\nWrite a handover plan and file all records, so a permanent lead can take over in July 2027.\nWHAT YOU BRING\n Required\nBachelor’s degree in life sciences, nursing, or a related field. A master’s degree is an asset.\n7 or more years in clinical research (sponsor, CRO, or site), with direct work on regulated trials.\nAt least 2 years in a lead role, such as trial manager, project lead, or clinical operations lead.\nWorking knowledge of FDA rules for clinical investigations (21 CFR Parts 11, 50, 56, and 812 or 312).\nExperience with trials outside the US whose data supports a US submission.\nWorking knowledge of ICH GCP and Canadian REB processes.\nExperience with trial documentation, audit readiness, and FDA inspection readiness.\nStrong written English and strong attention to detail.\nAbility to work on your own and manage many cases at once.\nLegal eligibility to work in Canada, or ability to contract as a Canadian business.\n Preferred\nExperience with compassionate use or expanded access, including FDA expanded access rules.\nMedical device trial experience (ISO 14155, FDA IDE).\nKnowledge of Health Canada trial authorization rules.\nClinical research certification (for example SOCRA or ACRP).\nExperience with an electronic data capture or trial management system.\nFrench language skills.\nExperience with small companies or start-ups.\nLOCATION AND COMPENSATION\nThis is a hybrid contract position based in Canada, ideally near Toronto. Onsite presence is expected as needed to support compassionate use cases at clinical sites; otherwise, work is remote.\nThe anticipated rate for this position is C$14,000 to C$17,000 per month. Actual compensation will be determined based on experience, qualifications, geographic location, and other job-related factors. Mitria Medical is committed to fair and equitable pay practices.\nEQUAL OPPORTUNITY\nMitria Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment decisions are based on qualifications, merit, and business needs. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic.\nTHIRD-PARTY RECRUITER NOTICE\nWe do not accept unsolicited resumes from staffing agencies or recruiters without a signed agreement in place. Any resumes submitted without such an agreement will be considered the property of Mitria Medical, and no fees will be paid if the candidate is hired. Agencies interested in submitting candidates may email .","description_format":"text","description_chars":4923,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[{"language":"French","level":"All levels","optional":true},{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[{"name":"Canada","iso":"CA","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Venture Capital","Angel Networks & Startup Accelerators"],"lifecycle":[{"event":"open","at":"2026-11-03T00:04:02Z"}],"visa":[],"liveness":{"score":85,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.849,"p_room":1,"age_days":9,"expected_fill_days":31,"reasons":["conf:3","win:early"],"computed_at":"2026-11-11T05:49:22Z"},"pay":null,"html_url":"https://alion.io/job/s3-ventures-clinical-lead-contract","json_url":"https://alion.io/job/s3-ventures-clinical-lead-contract.json","meta":{"generated_at":"2026-11-12T04:29:32Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":9761,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-13T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":704992},"rest":"https://alion.io/mcp/rest/get_company?id=704992"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fs3-ventures-clinical-lead-contract"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fs3-ventures-clinical-lead-contract"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fs3-ventures-clinical-lead-contract"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/s3-ventures-clinical-lead-contract\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fs3-ventures-clinical-lead-contract"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3650822}},{"tool":"search_jobs","arguments":{"company":"s3vc.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3650822},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. Docs: https://alion.io/developers"}}