Clinical Operations Manager at BiVACOR Inc (Huntington Beach, CA)

BiVACOR Inc· Huntington Beach, CA·1d ago

Role details

Work type

Onsite

Employment

Full-Time

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 prepare, every milestone you track, and every compliance requirement you uphold 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 high-impact, cross-functional role at the heart of BiVACOR’s clinical program, where your operational expertise will directly shape the success of our first-in-human and pivotal clinical studies. As Clinical Operations Manager, you will be the organizational backbone of site-level activity, ensuring every participating center is prepared, compliant, and ready to support patients receiving the world’s first Total Artificial Heart. You will bring meticulous attention to detail, a deep understanding of clinical trial operations, and a collaborative approach that keeps complex, multi-site programs on track.

Key Responsibilities

Oversee day-to-day operational logistics for clinical study activities at participating sites
Maintain site qualification documentation, essential regulatory binders, and operational SOPs
Track site-level operational milestones and flag deviations
Coordinate supply chain activities related to clinical device inventory and investigational materials
Support site initiation visits and ensure operational readiness prior to patient enrolment
Liaise with clinical research and regulatory affairs on site-level compliance requirements

What You Bring

Bachelor’s degree in Life Sciences, Health Sciences, or a related field; advanced degree or CRA/CRC certification preferred
3–5+ years of clinical operations, clinical trial management, or site management experience in a medical device or pharmaceutical environment
Solid understanding of ICH-GCP, FDA IDE regulations, and essential document requirements for investigational device studies
Experience managing regulatory binders, site qualification documentation, and investigational supply logistics
Proficiency with clinical trial management systems (CTMS) and electronic trial master file (eTMF) platforms
Can-do attitude — highly organized — strong cross-functional communication and stakeholder management skills
Willingness to travel to clinical sites as required; flexibility to support BiVACOR as our program scales

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 $118,000 to $154,000. 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.

Why work at BiVACOR Inc

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.

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.

Sources