CARENUUM

Agency Affiliation: U.S. Food & Drug Administration, CDER/CBER, Office of Surveillance and Epidemiology]

Carenuum is seeking a senior scientific or medical leader currently employed at the FDA to serve as the Principal Collaborator on our joint research efforts, starting with the FDA Research Collaboration Agreement.

The purpose of this role is to provide internal, real-world context and guidance on the design, execution, and interpretation of Post-Market Pharmacovigilance (PV) surveillance protocols that leverage Carenuum’s novel, resilient RWE platform (SAGA). The Collaborator ensures that our RWE methodologies are scientifically rigorous, clinically relevant, and have the highest probability of transitioning into an official, scalable surveillance standard for the Agency.

The Collaborator's efforts will be focused on maximizing the scientific, regulatory, and policy impact of the joint research:

• Co-Design & Review: Provide subject matter expertise on the development of the joint RCA protocol, ensuring that the RWE cohort definition and endpoint definitions (structured and unstructured) meet the Agency's internal data quality and clinical standards.
• Safety Signal Translation: Advise Carenuum’s Causal AI team on the internal FDA standards for classifying, adjudicating, and reporting a Drug Safety Signal. Ensure Carenuums unique computational signals are translated into formats (e.g., CIOMS, MedDRA) that are immediately actionable within the Agency’s existing PV infrastructure.
• Bias & Compliance Counsel: Provide critical feedback on the methodological design for mitigating confounding and selection bias, specifically advising on which methods (e.g., MLUQ, Causal Inference) will hold up best under the Agency's statistical review.
  

• Post-Market Strategy: Offer strategic guidance on the optimal deployment of RWE systems for large-scale safety surveillance.
• Policy Impact: Collaborate with Carenuum’s Chief Policy Officer to develop a policy narrative for the grants that aligns with the FDA's broader mission for data resilience and trustworthiness in healthcare.
• Dissemination: Serve as a joint scientific leader in the co-authoring and co-publishing of manuscripts detailing the RCA findings, lending the credibility of the Agency to the scientific community.
  

• Act as the primary bridge between Carenuum’s technical and scientific leads and relevant divisions within their FDA Center (e.g., Office of Surveillance and Epidemiology, relevant review divisions).
• Facilitate efficient review of interim research findings and help anticipate regulatory hurdles or policy questions that Carenuum's methodology might present.
  

• Current FDA Employment: Must be a current employee in good standing at the U.S. FDA in a senior scientific, medical, or regulatory role (e.g., Division Director, Medical Officer, Senior Reviewer, Epidemiologist).
• Domain Expertise: Demonstrated expertise in Pharmacovigilance, Drug Safety, Post-Market Surveillance, and/or RWE methodology within the regulatory context.
• Collaborative Authority: Ability to dedicate time and resources permissible under FDA ethics and partnership guidelines to engage actively on the research project.
• Scientific Acumen: Demonstrated history of publishing scientific work and leading complex, data-driven investigations.
  

This is a collaboration, not an employment offer. The benefit to the collaborator is non-pecuniary and includes:

• Principal Collaborator / Co-Investigator Credit on all resultant publications, posters, and presentations.
• Direct access to and co-development of cutting-edge RWE/AI technology.
• The opportunity to shape future national policy on RWE trustworthiness and surveillance standards.