Vice President of Clinical Operations

Vice President/Sr Vice President of Clinical Operations Location: U.S. remote based, with extensive travelThe SVP of Clinical Operations is the single accountable leader for our client's pivotal clinical trial — from protocol and statistical design, through FDA engagement and IDE submission, site activation, enrollment and monitoring, data curation and analysis, to the clinical modules of the De Novo submission.This is a build-and-run role at a small company: you will personally write, negotiate, and decide, while directing a CRO, a biostatistics group, an imaging core lab, and a growing internal team.You will be their clinical center of gravity. The clinical evidence you generate is the company's principal asset — it determines regulatory authorization, reimbursement, and hospital adoption.You will work directly with the CEO, the Board, outside regulatory counsel, their quality partner, their manufacturing partner, and the academic investigators who have carried the science this far.SCOPE OF RESPONSIBILITYTrial Design, Protocol & Statistical Strategy:Own the pivotal trial protocol end to end — authorship, cross-functional review, versioning, amendments, and final sign-off.Own the Statistical Analysis Plan (SAP) with the biostatistics group: endpoint definitions, powering and sample size, randomization and stratification, poolability analysis, missing data handling, interim analyses, and multiplicity control.Direct the mock pivotal analysis on the existing 50-patient cohort that finalizes study powering, and translate its output into the protocol and SAP.Define blinding and sham integrity procedures for a double-blinded, sham-controlled device trial — blinding of sites, patients, assessors and sponsor; sham device handling; emergency unblinding procedures; and a blinding-success assessment.Define inclusion/exclusion criteria enrollable in a neuro-ICU setting, including device-fit handling and confounder management.Design the imaging protocol and core lab charter: standardized acquisition, severity criteria, a 2+1 adjudication process with core-lab tiebreaker, and reader qualification.Define the informed consent strategy for an acutely ill population, including legally authorized representative consent, consent windows, and re-consent.FDA Engagement & Regulatory Submissions:Serve as clinical lead in all FDA interactions with the relevant device division.Own preparation, assembly, and submission of the IDE application under 21 CFR Part 812.Close open items flagged by FDA on the imaging core lab protocol, severity definitions, and reader assessment structure.Manage IDE lifecycle obligations: supplements for protocol changes, annual progress reports, and FDA information requests.Leverage Breakthrough Device Designation — sprint discussions, interactive review, Q-submissions — to de-risk open questions before they become deficiencies.Author and own the clinical sections of the De Novo classification request, including the benefit-risk narrative and proposed special controls.Support Pre-Submissions for follow-on indications and the clinical research plan supporting indication expansion.Sites: Identification, Activation, Contracting & Budgets:Build the site network — minimum three US sites, targeting a geographically and academically diverse group of leading neurovascular and neurocritical care programs.Run site feasibility and qualification: patient volume, ICU workflow, competing trials, PI engagement, and realistic enrollment forecasts.Own clinical trial agreements and site budgets: negotiation, indemnification, fair-market-value budgets, and payment triggers.Own the site payment process and associated Open Payments / Sunshine Act reporting.Drive IRB strategy — central versus local, reliance agreements, and continuing review.Own site activation timelines and the critical path to first-patient-in, and hold sites accountable to enrollment commitments.Design enrollment risk mitigation before it is needed: over-recruitment, staggered activation, and site-level intervention triggers.CRO & Vendor Selection and Management:Complete the CRO decision; negotiate scope, rate card, and change-order control terms.Select and manage the full vendor stack: biostatistics, data management, EDC platform, imaging core lab, central IRB, medical monitor, and device logistics.Own vendor qualification, contracting, and ongoing performance oversight.Control CRO change orders; track budget-to-actual monthly and flag variance to the CEO early.Trial Conduct & Operational Management:Own the trial operational plan, timeline, and critical path; report status, risk, and mitigation to the CEO and Board.Own the clinical monitoring plan — risk-based strategy, source data verification, visit cadence, CRA oversight, and follow-up.Own protocol and device training for investigators, coordinators, and ICU nursing staff, including bedside in-service on device application and workflow integration.Own device accountability, shipment, storage, and reconciliation at sites, and coordinate clinical supply with manufacturing.Manage protocol deviations: prevention, capture, trending, and corrective action.Build and lead the internal clinical team over time — clinical trial manager, CRAs, data manager.Safety, Oversight Committees & Compliance:Establish and charter the Data and Safety Monitoring Board (DSMB) and any clinical events committee; select members and run meetings.Select and manage the independent medical monitor and safety review process.Own safety reporting: AE/SAE definitions and capture, UADE determination and reporting to FDA, IRBs, and investigators within required timeframes.Ensure conduct complies with 21 CFR Parts 812, 50, 54, 56, 11, ISO 14155, ICH E6 GCP, and HIPAA.Own the Trial Master File and BIMO inspection readiness from day one — not reconstructed at submission.Interface with the Quality Management System on clinical procedures, training records, CAPA, and complaint handling.Own the clinical trial risk register, with documented mitigations.Data Management, Analysis & Reporting:Own eCRF design, EDC build, edit checks, user acceptance testing, and the data management plan.Own data curation and quality: query management, medical coding, external data reconciliation, interim data reviews, and database lock.Direct the statistical analysis, interpret the results, and own the clinical study report.Ensure the dataset is submission-ready and the analysis is reproducible and defensible under audit.Ensure ClinicalTrials.gov registration and results reporting obligations are met on time.Evidence Strategy Beyond the Pivotal:Build the clinical evidence roadmap for the second indication, real-world data pathway, and post-market strategy.Design the pivotal to also generate health economic endpoints and coverage-relevant data.Coordinate investigator-initiated studies at partner institutions so they strengthen, not compete with, the pivotal.Own the publication and scientific communication plan — abstracts, manuscripts, and podium presence at major relevant conferences.Build and manage the steering committee and KOL network; convert investigators into advocates.Corporate & Cross-Functional Leadership:Contribute to the Series A raise: clinical diligence materials, data room content, and investor meetings.Own the clinical budget — build it, forecast it, and manage to it.Report to the Board on clinical progress with clear metrics and honest risk assessment.Partner with engineering and quality on design freeze, V&V, and summative human factors.Support strategic partner and acquirer conversations with credible clinical and regulatory narrative.QUALIFICATIONSRequired:10+ years in clinical research within medical devices, with progressive leadership responsibility; 5+ years leading clinical operations functions or programs.Has personally led at least one pivotal IDE trial from protocol through database lock and regulatory submission. Program participation is not the same as ownership.Direct, hands-on experience preparing and submitting an IDE to FDA and managing the IDE lifecycle, including UADE reporting and supplements.Demonstrated command of 21 CFR Part 812, 50, 56, 11, ISO 14155, and ICH E6 GCP as applied to device trials — not pharma-only experience translated by analogy.Track record selecting, contracting, and managing CROs and specialty vendors, with successful control of scope and change orders.Experience negotiating clinical trial agreements and site budgets with academic medical centers.Fluency in clinical biostatistics sufficient to challenge a statistician productively — powering, endpoint selection, poolability, and bias control.Experience with blinded, sham- or placebo-controlled trial designs and the operational integrity they demand.Advanced degree (MS, MPH, PhD, PharmD, RN/BSN with equivalent experience, MD) or equivalent demonstrated expertise.Comfort operating without infrastructure — you will write the SOP, not request it from a department.Strongly PreferredNeurocritical care, stroke, neurosurgery, or neurology trial experience — particularly SAH, ICH, or acute ischemic stroke.Experience with imaging endpoints and imaging core lab management, including adjudication design.Prior experience at a venture-backed, pre-commercial medical device company through a successful regulatory authorization (De Novo, PMA, or 510(k) with clinical data).Experience with FDA Breakthrough Device Program mechanics.Experience generating reimbursement- and coverage-relevant evidence within a pivotal trial.Experience building a clinical function from the ground up — SOPs, systems, vendor stack, and team.Experience supporting fundraising or M&A diligence from the clinical side.ICU device deployment experience, including nursing workflow integration.