Senior Clinical Research Scientist

About the role

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. This role supports our Electrophysiology business, working on a Flex/Hybrid schedule with 2-3 days per week onsite in our Irvine, CA office.

Responsibilities

• Produce clinical study protocols and clinical study reports, ensuring scientific soundness and compliance with regulatory requirements
• Conducts literature & landscape reviews to identify concepts of importance to patients to inform evidence strategy
• Support and coordinate multiple real-world evidence research studies in partnership with external groups: participating study site staff, Clinical Research Organizations (CRO), and vendors, and with internal teams: medical affairs, data management, biostatistics, data programmers, and regulatory affairs
• Manage with supervision clinical trials including study budget assessment, fair mark value appraisal, contract development and execution, payments, and development of study related materials
• Ensure clinical research studies follow regulatory standards and maintain accurate, detailed documentation for audits and submissions
• Develop and deliver high-quality scientific manuscripts, abstracts, posters, and podium presentations for publication in peer-reviewed journals and presentation at major cardiovascular and Electrophysiology congresses
• Collaborate closely with internal cross-functional teams (Clinical, Biostatistics, Medical Affairs, Global Strategic Marketing, Health Economics and Market Access) and external physician authors to ensure accuracy, alignment, and scientific integrity
• Analyze and interpret clinical data; effectively communicate data using well-structured tables and visually compelling figures
• Support the strategic evidence planning for key products and studies, including first-in-human trials, pivotal studies, indication expansions, post-market surveillances, and registries
• Engage with Clinical Science & External Research associates and cross-functional teams to develop evidence strategy
• Adhere to external guidelines and Company policies governing the ethical development of clinical data publications while continuing to look at innovation in publication and scientific communications
• Maintain awareness of emerging trends and competitors in cardiovascular and electrophysiology therapy spaces to inform content development

Requirements

• Minimum of a bachelor’s degree in Life Sciences, Physical Science, Nursing, Biological Science, or closely related field
• Minimum of 2 years of direct involvement in clinical research trials and scientific publications in a medical industry or related setting
• Excellent written and oral communication skills
• Strong project management skills to balance multiple projects
• Excellent interpersonal skills, with the ability to build relationships and collaborate effectively with key partners across different time zones
• Demonstrated adaptability in fast-paced, evolving environments
• Knowledge of Good Clinical Practices, Evidence Generation Strategy, and ICMJE standards

Qualifications

• PhD/MD/PharmD with industry/academic research experience (Preferred)
• 3+ years of experience in cardiovascular and/or electrophysiology therapeutic areas (Preferred)
• Prior experience designing and executing clinical studies (Preferred)
• ISMPP CMPP™ or AMWA MWC® credentials (Preferred)
• Knowledge of electrophysiology procedures and terminology (Preferred)

Skills

• Analytical Reasoning
• Clinical Data Management
• Clinical Evaluations
• Clinical Trial Protocols
• Coaching
• Consulting
• Data Savvy
• Drug Discovery Development
• Good Clinical Practice (GCP)
• Medicines and Device Development and Regulation
• Persistence and Tenacity
• Regulatory Affairs Management
• Research Documents
• Resource Management
• Safety-Oriented
• Scientific Research
• Tech-Savvy

Pay

The anticipated base pay range for this position is: $92,000.00 - $148,350.00