Associate Director, Clinical Research & Operations

Cardiosense is a rapidly growing, venture-backed medical AI company that is redefining how we detect, monitor, and manage heart disease. We're developing novel wearable sensors and advanced machine learning algorithms that translate raw physiological signals into clinically actionable, digital biomarkers used to detect early signs of cardiac worsening, guide personalized therapy, and improve patient outcomes.

Our team brings together experts in data science, biosignal analysis, and medicine united by a common mission to identify and combat preventable cardiac disease. Cardiosense's solutions are built on over a decade of clinical research and we continue to collaborate with the world's leading academic institutions to introduce the next generation of cardiac monitoring and disease management.

ABOUT THE ROLE:

The Associate Director, Clinical Research and Operations will play a pivotal role in designing, planning, and executing clinical studies that validate Cardiosense’s medical AI products. This position is critical in bridging the gap between AI model development and real-world clinical application, ensuring that our products meet regulatory standards and are proven to improve clinical outcomes. The successful candidate will work closely with cross-functional teams, including data scientists, clinical researchers, product managers, and regulatory specialists, to drive the execution of clinical studies, data collection, and validation efforts.

WHAT YOU'LL BE DOING:

Study Design & Planning:

• Lead the design, development, and execution of clinical research studies to validate the performance of AI-based models for cardiovascular conditions.
• Collaborate with cross-functional teams t. o define study objectives, endpoints, inclusion/exclusion criteria, and study protocols.

Clinical Study Management: -Oversee the full lifecycle of clinical studies, including site selection, investigator training, study execution, patient recruitment, data collection, and quality assurance. -Ensure adherence to study timelines, budgets, and regulatory requirements.

Data Integration & Analysis: -Work closely with data science and product teams to define clinical data requirements for AI model validation. Ensure data quality and integrity through rigorous study design and execution processes.

Regulatory & Compliance Oversight: -Partner with regulatory affairs teams to ensure clinical studies are compliant with FDA, EMA, and other relevant regulatory bodies. -Assist in the preparation of regulatory submissions related to clinical trials and AI product validation.

Cross-Functional Collaboration: -Collaborate with internal teams, including engineering, product management, and clinical teams, to align research and clinical strategies with product development objectives. -Ensure seamless integration between AI model development and clinical research.

Clinical Operations Leadership: -Lead and manage clinical operations activitiesteams and vendors (e.g., CROs, clinical research associates) to ensure successful study execution. -Monitor performance, identify issues, and implement corrective actions as needed.

Publication & Reporting: -Author clinical study reports, manuscripts, and other documentation for publication in peer-reviewed journals and presentations at scientific conferences. -Present findings to internal stakeholders and external regulatory bodies as necessary.

Continuous Improvement: -Stay up to date with industry trends, regulatory changes, and best practices in clinical research and AI validation.  - Implement innovative strategies to optimize clinical research processes and enhance the quality and efficiency of study execution.

QUALIFICATIONS:

Education: -Master’s or Doctoral degree in Life Sciences, Clinical Research, Medicine, Engineering, or a related field.

Experience:

• Minimum 8-10 years of experience in clinical research, with at least 5 years in a leadership role managing clinical trials, preferably in the medical device, digital health, or AI/healthcare sectors. -Proven experience designing and executing clinical studies, including model validation trials, for medical AI or digital health products.
• Strong understanding of regulatory requirements (FDA, EMA, etc.) for clinical trials involving medical devices or AI-based solutions.
• Expertise in managing cross-functional teams and collaborating with data scientists, engineers, and product managers.
• Startup experience highly preferred

Skills:

• Strong project management skills with experience leading multi-disciplinary teams.
• Exceptional problem-solving abilities and attention to detail.
• Proficiency in clinical trial management software, electronic data capture (EDC) systems, and data analysis tools.
• Excellent written and verbal communication skills, with the ability to present complex technical information to a broad audience.

Preferred Qualifications:

• Experience in cardiovascular research or clinical trials.
• Background in AI, machine learning, or data science within a healthcare context.
• Knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and other relevant clinical research standards.
• Familiarity with AI model validation methodologies, particularly in healthcare applications.

Other:

• Ability to work in a fast-paced, dynamic environment.
• Strong leadership skills, with the ability to mentor and develop teams.
• Willingness to collaborate actively with others in the organization to define and execute the duties of the role.
• A passion for transforming healthcare through AI and innovative medical technology.