Vice President of Clinical Affairs

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. CardiaCare has completed multiple clinical studies, raised over $7/15 million in

funding, and is entering a pivotal regulatory phase with a multi-center trial and subsequent

commercialization. CardiaCare's mission is to redefine how millions of AFib patients are treated

worldwide.

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

CardiaCare's clinical portfolio includes multiple ongoing and planned studies—spanning pilot,

and pivotal trials—focused on atrial fibrillation reduction and additional potential indications

through neuromodulation therapy.

The
Vice President of Clinical Affairs
will be responsible for the design, execution, and

operational leadership of CardiaCare's 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

CardiaCare's clinical studies, with direct accountability for pivotal trial readiness,

contracting, protocol development, site activation, enrollment oversight, monitoring, and

data quality management.

●
Operational Excellence:
Ensure trials are executed on aggressive timelines with

outstanding site engagement, fast enrollment, tight compliance, and smooth patient

follow-up including ensuring first-patient-in (FPI) and last-patient-out (LPO) milestones

are achieved per the master timeline.

●
Data Strategy & Clinical Analytics:
Oversee clinical data infrastructure for real-time

monitoring, evidence generation, and data analytics (including AI-driven insights from

wearable use).

●
Governance & Risk Management:
Lead clinical risk management and chair a Clinical

Review Committee ensuring ongoing patient safety, data integrity, and compliance

●
Regulatory Alignment:
Partner closely with regulatory teams and consultants to ensure

compliance with FDA, GCP, and ICH requirements (including KOLs and FDA-facing

consultants) to align clinical trial design with regulatory expectations and reimbursement

endpoints.

●
Collaborate with Product & R&D
: Define clinical requirements for next-generation

devices. Ensures clinical work directly supports market success.

●
Define
long-term clinical strategy with the regulatory team, including study sequencing,

post-market evidence generation, and real-world data collection to support

reimbursement and market adoption.

●
Vendor & CRO Oversight:
Select and manage CRO (if selected) and vendor

relationships; collaborate with partners and hold them accountable for timelines,

deliverables, and budgets.

●
Budget & Resource Management:
Build and manage trial budgets; negotiate favorable

site and vendor terms; optimize operational efficiency.

●
Deliver
FDA-approvable pivotal study data on-time and within budget
.

●
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.

● Bachelor's degree required; advanced degree in life sciences, public health, nursing, or

related field preferred.

Why Join CardiaCare

Join a mission-driven company where you will:

● Lead all clinical programs advancing a first-in-class neuromodulation paradigm shifting

therapy for Afib, the world's most common cardiac arrhythmia.

● Lead the clinical function at a high-growth company developing a transformative therapy

for AFib.

● Be the driving force behind CardiaCare's 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 electrophysiologists and academic centers on a pivotal

IDE study

● 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

● A candidate's salary offer will be market competitive and based on their skills, education,

work location and experience. Compensation may also include bonuses consistent with

CardiaCare's corporate compensation plan. Note, the above description is not all-

encompassing and CardiaCare reserves the right to change or modify job duties and

assignments at any time.

● CardiaCare is an Equal Opportunity Employer. All qualified applicants will receive

consideration for employment 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. Any applicant with a disability who requires an

accommodation during the application process should contact the CardiaCare team to

request reasonable accommodation.