Director, Clinical Research

About Prenosis

Prenosis Inc. is an artificial intelligence company pioneering precision medicine in acute care. Our Immunix™ precision medicine platform drives the development of precision products and enables real-time delivery of optimal therapy. We've created and validated the first FDA-authorized AI biomarker for sepsis, the Sepsis ImmunoScore™.

We are seeking a Director of Clinical Research to join our growing team. The Director of Clinical Research leads our clinical research strategy and operations, from initial feasibility studies to post-market safety and efficacy evaluations. This role manages all aspects of our clinical research program, including protocol development, hospital site recruitment and management, and regulatory compliance. Working cross-functionally with internal teams and external partners, the Director oversees study implementation and collaborates closely with our data analytics team to ensure high-quality data collection and analysis. This position requires a strategic thinker who can both develop research plans and execute them effectively while maintaining the highest standards of scientific integrity.

Responsibilities

• Strategic Leadership: Develop clinical study strategies, approve protocols, assess research opportunities, and build relationships with key opinion leaders

• Site Management: Recruit and manage hospital research sites, serve as engagement leader with site leadership, and oversee study activation processes

• Program Administration: Provide oversight of program, including preparation of clinical reports, management of budgets, maintain regulatory compliance, and lead cross-functional teams

• Data Oversight: Monitor data collection quality and collaborate with data science teams

• Travel: <40%

Qualifications and Experience

• Bachelor's degree in clinical research, medicine, pharmacology, or related field (graduate degree preferred)

• 5+ years of clinical research experience (7+ years preferred)

• GCP certification and knowledge of regulatory requirements

• Strong understanding of clinical trial processes and methodologies

• Excellent communication, leadership, and strategic planning skills

• Experience in Regulated Medical Device industry preferred

Competencies

• Strong strategic planning and execution abilities.

• Excellent leadership and team management skills.

• Exceptional written and oral communication skills.

• Outstanding interpersonal skills, ability to communicate and build relationships at all levels with internal and external stakeholders.

• Advise senior management in strategic conversations with customers.

• Ability to evaluate and provide program effectiveness and success.

• Fiscal responsibility and accountability for annual budget.

• Ability to understand technical issues and the impact on projects.

• Drive innovation through functional area, think creatively, harness internal resources, lead and motivate staff to solve problems.

• Articulate independent assessments of key business drivers and impact to operations.

What We Offer

• Comprehensive Medical, dental, and vision coverage

• 401(k) with company match

• Unlimited PTO

• Major opportunity for career development to make significant impact at an exciting growth-stage company

• Collaborative and innovative work environment

• Chance to make a real impact on patient care

• Opportunity to work on cutting-edge AI technology in healthcare

Prenosis is an Equal Opportunity Employer