Head of Clinical Affairs
Title: Head of Clinical Affairs
Location: California (Hybrid)
Department: Clinical Affairs
Employment Type: Full‑Time
Industry: Medical Devices - Electrophysiology
Position Overview:
The Head of Clinical Affairs will be the leader responsible for overseeing the full clinical strategy, evidence generation roadmap, and execution of all clinical programs across feasibility, pivotal, and post‑market studies. This individual will shape clinical direction, drive regulatory‑critical evidence generation, build high‑performing teams, and serve as the company's primary clinical voice across internal and external stakeholders.
This role requires deep electrophysiology expertise, strong leadership capability, and a strategic mindset to guide the company through global product approvals, commercialization, and clinical adoption.
Key Responsibilities:
Clinical Strategy & Vision
- Develop and own the global clinical affairs strategy aligned with product development and corporate priorities.
- Shape the evidence roadmap to support regulatory submissions, labeling, reimbursement, and clinical adoption.
- Assess evolving clinical, scientific, and industry trends in electrophysiology to inform strategic direction.
Clinical Program Leadership
- Lead design and oversight of early feasibility, pivotal IDE studies, post‑market registries, and real‑world data initiatives.
- Serve as the senior clinical representative for protocol strategy, endpoint justification, and study design.
- Ensure clinical programs meet quality, scientific, regulatory, and ethical standards globally.
Regulatory & Scientific Leadership
- Lead clinical strategy for submissions to FDA, EMA, PMDA, and other global regulatory agencies.
- Represent the company in meetings with regulators, clinical bodies, and advisory panels.
- Oversee preparation and accuracy of clinical content for submissions, publications, presentations, and scientific communications.
Cross‑Functional Collaboration
- Partner with R&D on design inputs, risk analysis, preclinical‑to‑clinical transitions, and human factors planning.
- Support Health Economics & Market Access with clinical evidence for payer strategies.
- Guide Marketing and Commercial teams on clinical messaging, KOL engagement, and product training.
Stakeholder Engagement
- Build and maintain strong relationships with electrophysiologists, EP lab leaders, research centers, and global KOLs.
- Chair or support Clinical Advisory Boards and scientific steering committees.
- Represent the company at conferences, symposia, and scientific forums.
Team Leadership
- Hire, mentor, and lead Clinical Affairs staff across clinical operations, medical writing, clinical science, and monitoring.
- Define organizational structure, processes, and KPIs for a world‑class clinical organization.
- Foster a culture of excellence, collaboration, and continuous improvement.
Qualifications
Required
- Bachelor's degree in biomedical engineering, life sciences, nursing, or related field (advanced degree preferred).
- 12+ years of clinical research experience within the medical device industry, including significant experience in electrophysiology, cardiac rhythm management, mapping/ablation systems, or related technologies.
- Proven track record leading global pivotal trials and interacting with regulatory authorities at a senior level.
- Strong understanding of EP clinical workflows, arrhythmia mechanisms, intracardiac signals, and EP lab operations.
- Expert knowledge of GCP, ISO 14155, and global clinical regulatory requirements.
- Exceptional leadership, communication, and strategic‑thinking abilities.
Preferred
- Experience with Class III cardiac implantable devices (ICD, CRT, pacemakers).
- Prior leadership experience in a startup or fast‑growth medtech environment.
- Established relationships within the electrophysiology/KOL community.
Why:
- Lead the clinical vision for breakthrough electrophysiology technologies.
- Directly shape global clinical evidence and regulatory strategy.
- Work with world‑class engineers, clinicians, and innovators in a mission‑driven culture.
- Competitive compensation, equity, and a comprehensive benefits package.
- Opportunity to impact patient care and define the future of EP therapy.
FAQs
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