---
title: 'Clinical Research Manager at BiVACOR Inc'
canonical: 'https://feeny.ai/job/clinical-research-manager-bivacor-inc-huntington-beach-fasfw5r8rsfb'
type: 'job'
last_seen: '2026-09-13'
---

# Clinical Research Manager at BiVACOR Inc

- **Company:** BiVACOR Inc
- **Location:** Huntington Beach, CA
- **Employment:** full-time
- **Work type:** onsite
- **Posted:** 2026-05-26
- **Last confirmed live:** 2026-09-13
- **Apply:** https://jobs.ashbyhq.com/bivacor-inc/1478ae35-c60a-47b1-bc03-22ca6a60d5f0

## Job description

Help Us Build the Future of the Human Heart.

At BiVACOR, we’re developing the world’s most advanced total artificial heart, a technology capable of saving millions of lives around the world. We’re a team united by purpose, working on something truly unprecedented. Every site you activate, every team member you develop, and every data point you interpret plays a direct role in giving patients another shot at life. If that’s the kind of work that gets you out of bed in the morning, we think you belong here.

## About the Role

This is a senior, high-impact leadership role at the center of BiVACOR’s US clinical program, where your expertise will shape how we conduct, manage, and report on one of the most groundbreaking medical device studies of our time. As a Clinical Research Manager, you will own end-to-end US IDE study operations, leading a team of clinical research professionals, ensuring regulatory compliance across all active sites, and driving the clinical strategy that will help bring the world’s first Total Artificial Heart to patients who need it most. You will bring deep clinical trial expertise, strong leadership instincts, and the scientific acumen to translate complex data into compelling, accurate clinical narratives.

## Key Responsibilities

- Manage all US IDE clinical study operations including site activation, enrolment, and monitoring
- Lead and develop a team of Clinical Research Specialists/Site Managers and Clinical Research Associates
- Ensure US sites maintain GCP compliance, FDA regulations, and protocol adherence
- Serve as the primary liaison with US IRBs, site Principal Investigators, and study coordinators
- Maintain the Trial Master File per ICH E6(R2) and ISO 14155:2020; prepare for and support inspections and audits
- Collaborate on clinical strategy and author key clinical documents including clinical study protocols, clinical study reports, clinical evaluation plans/reports, annual progress reports, risk-benefit analyses, and clinical marketing materials
- Develop a deep understanding of clinical data; interpret and communicate complex results in a clear, concise, and scientifically accurate manner across a wide range of audiences

## What You Bring

- Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, or a related field; advanced degree preferred
- 5+ years of clinical research experience in a medical device or pharmaceutical environment, with at least 3 years in a management or team leadership role
- Extensive experience managing US IDE studies; thorough knowledge of FDA regulations (21 CFR 812), ICH E6(R2) GCP, and ISO 14155:2020
- Demonstrated experience authoring regulatory and clinical documents including protocols, CSRs, CEPs/CERs, and annual progress reports
- Strong data interpretation skills with the ability to synthesize complex clinical results and present them clearly to scientific, regulatory, and lay audiences
- Prior experience with cardiac or implantable device studies strongly preferred; Class III medical device experience an advantage
- Can-do attitude, strategic thinker with strong leadership and cross-functional communication skills
- Willingness to travel to US clinical sites and attend key meetings and conferences as required

## What We Offer

BiVACOR offers a competitive compensation package and comprehensive benefits, including:

- 401(k) with company matching
- Medical, dental, and vision insurance
- Health Savings Account (HSA) & Flexible Spending Account (FSA)
- Life insurance & Employee Assistance Program
- Generous paid time off

This role may be based at BiVACOR’s Huntington Beach headquarters. The expected salary range for this position based in Huntington Beach California is $110,000 - $150,000. Actual compensation will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Relocation benefits are not available for this posting.

Apply today and be part of something extraordinary.

BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

## About BiVACOR Inc

## Company Overview
- **One-liner**: BiVACOR is a clinical-stage medical device company developing the world’s first titanium Total Artificial Heart (TAH) using magnetic levitation technology to replace both ventricles of a failing heart.
- **Entity Type**: Private (Clinical-stage, Series B-III)
- **Headquarters**: Huntington Beach, California, USA (with clinical offices in Houston, Texas, and international offices in Gold Coast, Australia)
- **Founded**: 2008
- **Founders**: Daniel Timms, PhD (Founder & CTO)

## Core Business
- **Primary industry**: Medical Devices / Cardiovascular Therapeutics
- **Target customers**: B2B (Hospitals, Cardiac Surgery Centers, Transplant Centers); End-users are patients with end-stage biventricular heart failure awaiting a heart transplant.
- **Mission or purpose statement**: "Replacing Hearts. Restoring Lives." The company is committed to addressing the global unmet need of patients with end-stage heart failure by providing a next-generation, long-term life-extending solution.

## Products & Services
- **BiVACOR Total Artificial Heart (TAH)**: A clinical-stage, implantable medical device designed to completely replace the function of both ventricles of a failing heart. It is a valveless, electro-mechanical rotary blood pump that uses a single, magnetically levitated (MAGLEV) rotor to pump blood to both the body and the lungs. The device is made of titanium, has no mechanical bearings or flexing diaphragms, and is designed to be compact, durable, and powerful (capable of flows over 12 L/min). It is intended as a bridge-to-transplant for patients with end-stage biventricular heart failure.

## Market Standing
- **Valuation/Market Cap**: Not publicly available (Private company).
- **Key Metric**: Total funding raised is **$59.75M** (latest round: Series B-III of $9M, raised ~2 years ago). The company is currently conducting an FDA-approved Early Feasibility Study (EFS).
- **Notable Investors/Partners**: Key partners include the Texas Heart Institute, Baylor St. Luke’s Medical Center, and St. Vincent’s Hospital Sydney. The company has received funding from various sources including an $18M round to move the TAH through first-in-human studies. The company has a robust collaborative network extending nationally and internationally.
- **Growth Signals**: The BiVACOR TAH has been successfully implanted in five patients as part of an FDA Early Feasibility Study (EFS), with all five bridged to a donor heart transplant. The FDA has greenlit an expansion of the EFS to an additional 15 patients. The device was accepted into the FDA’s Total Product Life Cycle (TAP) Advisory Program. The first Australian implantation occurred in November 2024, with the TAH in place for over 100 days. The company received FDA Breakthrough Device Designation.

## Competitive Advantages
- **Proprietary MAGLEV Technology**: The BiVACOR TAH uses a single, magnetically levitated rotor with no mechanical bearings, valves, or flexing diaphragms, eliminating mechanical wear and friction. This is a fundamental design innovation compared to traditional volume-displacement TAHs.
- **Simple, Durable Design**: The device has only one moving part (the rotor), which is suspended via magnetic levitation. This simplicity is a major differentiator, promising greater long-term durability and reliability.
- **Compact and Powerful**: The TAH is designed to fit most men and women (BSA >1.4 m²) and can provide high flows over 12 L/min, sufficient for an adult male during exercise.
- **Regulatory Momentum**: The device has received FDA Breakthrough Device Designation, is part of the FDA’s TAP (Total Product Life Cycle Advisory) Program, and has successfully completed a first-in-human Early Feasibility Study (EFS) with all five patients bridged to transplant. The EFS has been expanded to an additional 15 patients.

## Strategic Focus
- **Clinical Validation & Regulatory Approval**: The primary focus is on completing the expanded Early Feasibility Study (EFS) and progressing toward a pivotal study and eventual FDA premarket approval (PMA).
- **Global Expansion**: Following successful implants in the US and Australia, the company is building a global footprint and clinical evidence base.
- **Commercialization Preparation**: With the appointment of a new CEO (Jim Dillon, a veteran medical device executive) and acceptance into the FDA’s TAP program, the company is preparing for eventual commercialization and market entry.

## Why Work Here
- **Mission-Driven Work**: Employees directly contribute to a life-saving technology that addresses a critical global unmet need for patients with end-stage heart failure.
- **World-Class Team**: Work alongside leading biomedical engineers and renowned cardiac surgeons, including pioneers in the field of artificial hearts.
- **Innovative Technology**: Be at the forefront of a paradigm shift in artificial heart design, working with cutting-edge MAGLEV and rotary blood pump technology.
- **Culture**: The company emphasizes collaboration, hard work, and recognizing team members. It is described as having a "highly driven and performing team" with a "robust collaborative network."
- **Remote/Hybrid/Office Policy**: Not explicitly stated, but the company has multiple physical office locations (Huntington Beach, CA; Houston, TX; Gold Coast, Australia), suggesting an on-site or hybrid model is likely for engineering and lab roles.
- **Benefits & Perks**:
    - **Health**: Medical (HMO/PPO options with fully employer-funded premiums for some plans), Dental, Vision, Short-term & Long-term Disability.
    - **Time Off**: Generous vacation (80 hours in year one, increasing to 136 hours by year 7) plus an additional 80 hours of PTO per year.
    - **401(k)**: 4% non-elective employer contribution (immediately vested after 90 days) plus an elective employer match up to 6%.
    - **Incentives**: Short-term and long-term incentive plans are part of the benefits package.
    - **Culture**: Described as collaborative, hard-working, and focused on recognizing team members. The company is an equal opportunity employer committed to an inclusive environment.

## Sources
1. [bivacor.com](https://bivacor.com/)
2. [bivacor.com/careers](https://bivacor.com/careers/)
3. [bivacor.com/news](https://bivacor.com/news/)
4. [cbinsights.com](https://www.cbinsights.com/company/bivacor)
5. [jobs.ashbyhq.com](https://jobs.ashbyhq.com/bivacor-inc)

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