Job Description

Position Summary 

Advanced Bifurcation Systems (ABS) is a coronary medical device developer and manufacturer based in the San Francisco Bay area (Livermore, CA), with a fully developed FDA Class III platform designed to treat all indications of bifurcation disease. With over 75 issued US and international patents, as well as an FDA Breakthrough Device Designation, ABS is poised to become the industry’s standard of care.

Reporting to the President/COO, the Manager/Director of Clinical Operations has assigned responsibilities across ABS’ clinical research, clinical trial management, and regulatory affairs arms. Job responsibilities will include, but are not limited to, designing clinical studies for an FDA Class III device, overseeing the timely execution of clinical investigations, and developing enterprise strategies in concert with ABS go-to-market timelines. The Manager/Director of Clinical Operations will have, first and foremost, a deep understanding of clinical workflows, clinical research protocols, and a strong ability to communicate with physician investigators. They will also possess a robust understanding of regulatory (both domestic and international) requirements and submission processes, playing an essential role in demonstrating the safety and performance of the ABS platform. The Manager/Director of Clinical Operations will collaborate closely with physicians, site administrators, clinical research coordinators (CRCs) and CROs to identify and implement appropriate clinical protocols and assist in enrolling and monitoring study participants. They will moreover be responsible for ensuring compliance with IRBs/DSMBs, managing informed consent and case report forms (CRFs), and the completion of all related regulatory (FDA, EMA, Health Canada, etc.) documents of a clinical nature.

This position will be structured as a contractual role, anticipating a transition to full-time (W-2) employment, contingent on performance, upon completion of the contract period and in alignment with regulatory timelines. Upon commencement of the W-2 role, in-person attendance at ABS headquarters in Livermore, CA will be required. This position requires travel up to 40%

Qualifications 

• Bachelor’s or Master’s degree in the health sciences or life sciences (e.g., nursing, health administration, public health, biology, bioengineering, etc.) 
• Functional leadership experience in a clinical program focused on the development and commercialization of a medical device, ideally an FDA Class III drug-coded combination implantable
• Ability to coordinate and communicate effectively with physicians and other care team members, possessing a granular understanding of hospital workflows and competing interests 
• Experience in translating research from preclinical (animal) studies to clinical (human) trials, ensuring effective transition between phases
• Strong working knowledge of applicable domestic and international regulatory requirements, such as US FDA Regulations Relating to Good Clinical Practice and Clinical Trials (21 Title Parts 50, 54, 56), International Conference on Harmonization − Good Clinical Practice (ICH-GCP), EU MDR, etc.
• 5+ years of relevant industry or research experience

Responsibilities 

• Complete and submit all necessary documentation to relevant IRBs/DSMBs (e.g., protocols, recruitment materials, investigator/site forms, adverse event reporting plans, etc.)
• Maintain appropriate study records according to Federal Regulations (US and international) and ICH Good Clinical Practice
• Formulate and communicate clinical study objectives (such as  clinical endpoints) , plan study implementation, manage partnerships, and monitor Clinical Research Organizations (CROs)
• Drive activities to identify, evaluate, and qualify clinical sites
• Prepare, submit, and negotiate effective and timely clinical site budgets and study contracts through to execution; identify and communicate resource gaps for studies
• Be proactive with physician investigators in onboarding, reviewing documents, directing appropriate care, and ensuring compliance, training and crafting educational materials (in various mediums) as necessary
• Safeguard the integrity of collected clinical data, ensuring adherence to appropriate access controls and privacy standards in accordance with regulatory requirements (including HIPAA)
• Maintain inspection readiness for Trial Master Files (TMFs), sites, and studies by overseeing regular audits and ensuring timely resolution of findings
• Ensure the prompt delivery of any required clinical analyses, summaries, presentations, or other outputs to internal or external stakeholders
• Regularly report to the ABS management team on clinical study progress, challenges, achievements, and planned or recommended next steps
• Continuously monitor the ABS device by conducting  Post-Market Clinical Follow-Up (PMCF) activities to collect, evaluate, and report long-term safety and performance data
• Other related duties and responsibilities as mutually agreed upon with the ABS management team

Attributes 

• In-depth understanding of clinical research (including medical terminology), hospital operations, and clinical regulatory requirements
• Advanced social and negotiation skills (including assertiveness, when necessary and the ability to “read the room”) to effectively serve as an intermediary between stakeholders with sometimes differing perspectives
• Strong organizational and time management skills, setting priorities and actively driving clinical projects with competing interests, in high-pressure situations
• Ability to navigate a rapidly evolving “startup” environment, “wearing multiple hats”, proactively and nimbly shifting responsibilities as necessary
• Ability to earn influence among management as trusted counsel and to mentor junior team members
• A commitment to continuous learning and professional development, with motivation for career growth with commensurate skill cultivation

Physical Demands 

Requirements of this position include the need to frequently stand, walk, sit, and use a computer for extended periods. Specific vision abilities required by this job include close/distant vision and depth perception. This position also requires the use of Personal Protective Equipment (PPE), as needed.

Compensation

• Contractual Period: Hourly rate between $85 and $135 per hour, with no hours cap, but in accordance with company needs.
• W-2 Employee : Title of “Manager” or “Director” will be determined based on performance during contractual period, with salary range for Manager being $140,000 – $180,000 and for Director being $180,000 – $220,000 USD per annum, plus benefits, potential for performance-based bonus, and opportunity for equity participation.

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