Sr. Director, Clinical Strategy and Clinical Operations

Company Profile

Hyperfine (NASDAQ: HYPR) is the groundbreaking MedTech company that created Swoop, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) system capable of providing neuroimaging at the point of care. Our mission is to transform patient care by creating access to life-saving diagnostics and actionable data at the point of care.

Today, eighty percent of the world’s population lacks access to MRI. Hyperfine is on a mission to address the limitations of current imaging technologies and make MR imaging accessible anytime and anywhere.

Do you have a background in magnetic resonance imaging, deep learning, electrical engineering, physics, or related fields? What about health equipment sales, business development, or marketing? Hyperfine lives and works on the cutting edge of medical imaging accessibility. If you enjoy a challenge as much as you value a committed workplace, we could be the next step in your rising career.

 

Job title: Sr. Director, Clinical Strategy and Clinical Operations

Location: Palo Alto, California

 

SUMMARY:

As the Senior Director of Clinical Strategy & Clinical Operations at Hyperfine, you will develop and drive our clinical strategy, lead a dynamic team to generate clinical evidence in our existing use cases and drive our clinical focus in neurodegenerative and neurointerventional areas for our groundbreaking portable MRI (Magnetic Resonance Imaging) technology. Collaborating closely with engineers, product managers, medical directors, regulatory, quality, and commercial teams, you will play a pivotal role in advancing Hyperfine's mission to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging and data solutions.

 

RESPONSIBILITIES:

Overall Responsibilities:

• Cultivate a strategic clinical ecosystem through fostering collaborator and corporate business partnerships aligned with Hyperfine’s growth objectives.
• Lead and develop Hyperfine's Clinical teams, aligning with business, regulatory, and product objectives.
• Develop strategies to assess feasibility, expand clinical evidence, and support adoption of ultra-low-field portable MRI.
• Collaborate cross-functionally to design studies, establish study goals, timelines, deliverables, and oversee study progress.
• Implement best practices for clinical study design, data collection, analysis, and regulatory compliance.
• Manage clinical studies with our user groups to generate evidence for clinical/patient claims and Hospital ROI, contributing to clinical use case growth.

 

Clinical Operations:

• Efficiently manage, plan, and execute clinical studies ensuring patient safety, protocol adherence, and quality.
• Build and sustain relationships with clinical partners and Key Opinion Leaders to optimize study design, execution, and explore new value propositions.
• Design, oversee, and report on innovative clinical studies assessing feasibility, viability, and new product development.
• Manage clinical  team budget, ensuring resource allocation for efficient, high-quality studies.

 

KNOWLEDGE AND SKILL:

• Strong experience working with external and internal stakeholders including Clinical, R&D, Product, Quality and Regulatory, Service, etc.
• Exceptional team leadership skills with a capacity to take ownership of processes or projects.
• Ability to collaborate effectively across functions, influence stakeholders, and manage regulatory requirements.
• Excellent written and verbal communication skills, coupled with strong organization and multitasking capabilities.
• Analytical, articulate, technically savvy, and professional, adept at managing schedules, travel plans, and expenses.
• Demonstrated success in managing clinical business partnerships and studies.

 

EDUCATION/EXPERIENCE REQUIRED:

• Master's degree (Ph.D. preferred) in biomedical engineering, medical physics, or related field.
• 10+ years of experience in clinical studies, clinical study design.
• Minimum 5 years of supervisory experience, demonstrating strong team management skills.
• Proven success in clinical research, multi-center trials, and medical device industry.
• Demonstrated leadership in a medical device startup environment supporting business needs throughout the product lifecycle.

 

PHYSICAL DEMANDS:

• Flexibility to travel (up to 30% time) and work from our Palo Alto, CA or Guilford, CT offices as needed to fulfill work goals.