CARENUUM

Company Description

CareNuum is an independent initiative dedicated to addressing critical data challenges across the therapeutic lifecycle, from trial design to long-term follow-up. We are committed to defining technical standards for longitudinal data integrity, addressing real-world evidence (RWE) data blind spots, and developing systems for verifiable data provenance. Our mission is focused on advancing the scientific methodologies necessary for high-integrity, longitudinal evidence in biomedical research. By addressing the data trust deficit, we aim to accelerate the clinical development of advanced therapeutics.

The Role:

Lead our engagement with federal regulatory agencies and health policy stakeholders. You'll serve as the senior voice translating our technical capabilities into regulatory strategy, ensuring everything we build aligns with FDA requirements and healthcare policy realities. This isn't a figurehead position—you'll shape the scientific direction, co-author grant applications, and serve as primary liaison with federal partners.

What You'll Do:

• Lead grant application development, translating technical concepts into compelling narratives for federal reviewers
• Design study protocols and regulatory strategies that satisfy both scientific rigor and policy requirements
• Serve as primary interface with FDA, NIH, and other federal agencies throughout project execution
• Build and maintain relationships with Critical Path Institute consortia, academic medical centers, and policy organizations
• Guide the team on regulatory pathways for real-world evidence acceptance across different therapeutic areas
• Mentor junior team members on navigating the complex landscape of drug development and health policy

What Makes You Right for This:

• MD or PhD in health policy, biomedical science, or related field—we care more about your judgment than your credentials
• Senior leadership experience at FDA (CBER, CDER, OTP preferred), NIH, or equivalent regulatory/policy role—you've seen how decisions actually get made, not just how they're supposed to be made
• Deep understanding of real-world evidence frameworks, drug approval processes, and post-market surveillance requirements
• Track record of successful federal grant applications (SBIR, STTR, NIH R01, or similar)—you know what reviewers look for
• Ability to explain complex regulatory concepts to technical audiences and complex technical concepts to regulatory audiences
• Comfortable working in lean startup environments where titles matter less than impact

Why This Role Matters:

Regulatory credibility is everything when proposing novel infrastructure to federal agencies. Your experience ensures we're not building something technically impressive but regulatorily irrelevant. You're the reason FDA takes our calls and ARPA-H believes we can execute.

What Success Looks Like:

• Grant applications score in fundable range (top 20th percentile) based on regulatory and policy merit
• Federal partners actively engage with our proposals rather than politely declining
• Study protocols pass regulatory scrutiny on first submission
• Team avoids costly missteps by anticipating regulatory concerns before they become problems

Compensation & Timeline:

Part-time initially (10-20 hrs/month) supporting grant applications and partner outreach. Upon successful funding: full-time role for 2-3 years with competitive salary reflecting senior federal experience. Potential conversion to permanent role with equity participation depending on subsequent funding rounds.

Location: Remote with occasional travel to FDA (Rockville, MD), partner sites, and team meetings