Vice President of Clinical Affairs (Los Angeles)

Location : HQ (Los Angeles, CA; preferred) or Remote (exceptional candidates)

Reports to : Reports to CEO and partners closely with Chief Scientific Officer and VP QA / RA &

CTO

About CardiaCare

CardiaCare is a fast-growing medical device company developing a breakthrough non-invasive therapy for atrial fibrillation (AFib). Our novel wearable integrates advanced cardiac arrhythmia monitoring with proprietary neurostimulation to deliver closed-loop, patient-centric AFib management. CardiaCares clinical portfolio includes multiple completed, ongoing, and planned studiesspanning pilot and pivotal trialsfocused on AFib recurrence reduction and symptom improvement, as well as additional potential indications via its neuromodulation platform.

We are a mission-driven, execution-focused team building a category-defining technology in cardiac arrhythmia care. This is a rare opportunity to shape and lead clinical development from the ground up at a transformative stage in our journey.

Position Overview

The Vice President of Clinical Affairs will be responsible for the design, execution, and operational leadership of CardiaCares clinical programs, including our US pivotal trial. This role requires an executive who can combine strategic leadership with hands-on execution comfortable both in the boardroom and at the clinical site level doing the work.

The VP of Clinical must be meticulous and data-driven, with the credibility to engage KOLs, investigators, and regulatory authorities, while also being action-oriented and willing to directly manage budgets, CROs, patient enrollment, and monitoring to ensure flawless study execution. The ideal candidate is a proven leader who thrives in fast-paced environments and one who can engender confidence both internally and externally, inspire a clinical team, and serve as a trusted subject matter expert to hospital systems, investigators, and partners. The VP of Clinical will work collaboratively with the executive leadership team as well as cross-functionally with regulatory, R&D, and reimbursement leaders, while also building and leading a high-performing clinical operations team.

Key Responsibilities

Clinical Trial Leadership : Drive end-to-end operational planning and execution of CardiaCares clinical studies, with direct accountability for clinical trial readiness, contracting, protocol development, site activation, enrollment oversight, monitoring, timeline management, and data quality management. Primary outcome is to deliver first-class pivotal study results that are both on time and within budget.

Operational Excellence : Ensure trials are executed on aggressive timelines with outstanding site engagement, fast patient enrollment, tight patient and site compliance, complete database management, and smooth patient follow-up. Manage the unique complexity of home-based clinical studies. Collaborate with leadership team and clinical investigators, and lead execution on thoughtful patient selection, advanced study protocols, and patient compliance management.

Clinical Strategy Leadership : Define the company clinical strategy (near-term and long-term), in collaboration with the other relevant departments. Scope includes study design, study sequencing, publications, clinical marketing, post-market evidence generation, and real-world data collection. Goal is to maximize company outcomes for regulatory clearance, clinical and user adoption, and reimbursement.

Regulatory Alignment : Partner closely with regulatory, R&D, and market access teams, including external consultants, to ensure tight compliance with FDA, GCP, and ICH requirements (including KOLs and FDA-facing consultants) and alignment of clinical trial design with company goals for regulatory and reimbursement milestones.

Vendor & CRO Management : Select and manage relevant vendor and CRO relationships; collaborate with partners and hold them accountable for timelines, deliverables, and budgets. Decide strategically on what should be done in-house versus with external vendors.

Budget & Resource Management : Build and manage trial budgets; negotiate favorable site and vendor terms; optimize operational efficiency.

Site & Investigator Engagement : Establish strong relationships with KOLs, PIs, research coordinators, and other clinical staff to drive rapid enrollment and world-class trial performance.

Cross-Functional Collaboration : Work closely with executive leadership to align clinical execution with R&D, product, and regulatory goals.

Team Development : Recruit, mentor, and scale a high-performing clinical operations team as CardiaCare grows.

Travel : Willingness to travel frequently to sites, vendors, and HQ to ensure operational excellence.

Qualifications

10+ years of clinical operations / clinical affairs leadership in the medical device industry. Experience as a VP / SVP in an early-stage / growth-stage medical device company is a strong plus.

Demonstrated success leading multi-center pivotal device trials ; cardiac experience highly preferred. Experience with at-home, wearable trials is a strong plus.

Hands-on operator with experience in site contracting, budget negotiations, CRO / vendor oversight, and trial logistics.

Deep understanding of FDA regulations, GCP, and ICH guidelines; proven experience with FDA interactions preferred.

Must have excellent leadership and interpersonal skills, with proven ability to engender credibility and confidence internally and externally, and to represent the company with outstanding executive presence.

Action-oriented with a results-focused work ethic and a positive, can-do attitude.

Effective leadership, people management, and communication skills; a natural team-builder and mentor who is also willing to be hands-on.

Demonstrated ability to thrive in a resource-constrained, fast-paced startup environment and to deliver results under pressure.

Experience in early-stage startups and comfort building processes, systems, and teams from scratch.

Bachelors degree required; advanced degree in life sciences, public health, nursing, or related field preferred.

Why Join CardiaCare

Lead all clinical programs, strategy, and execution at a high-growth company developing a transformative therapy for AFib.

Be the driving force behind CardiaCares clinical trials, shaping the path to FDA approval and commercialization.

Work directly with a proven and dedicated leadership team and world-class advisors deeply committed to clinical excellence.

Collaborate with world-renowned cardiologists, cardiac electrophysiologists, and medical systems.

Build and mentor a high-performing global clinical operations team.

Join a mission-driven organization where your impact is immediate, visible, and transformative.

Benefits & Equal Opportunity Statement

CardiaCare is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity or expression, national origin, age, marital status, disability, veteran status, or any other characteristic protected by law. Applicants requiring accommodation during the recruitment process should contact the CardiaCare team.