Co-Founder - Regulatory Strategy & Clinical Evidence

’m looking for a regulatory scientist or clinical evidence expert interested in helping shape how new forms of clinical data are evaluated in research and regulatory environments.

Synthetic Ascension is exploring how synthetic data and probabilistic reconstruction of fragmented patient histories could help address a persistent challenge in rare disease research: the lack of usable longitudinal data in small cohorts.

The goal is not to replace real clinical data, but to complement existing datasets and registries, helping researchers reconstruct missing patient timelines and generate stronger evidence from incomplete records.

This role would focus on the regulatory and evidence credibility side of the platform.

What you’d help shape

• How synthetic or reconstructed patient data fits within FDA and EMA evidence frameworks
• Guardrails for regulatory credibility and data governance
• Validation approaches for synthetic cohorts and external control arms
• Alignment with real-world evidence (RWE) guidance
• Scientific framing for future regulatory discussions

Ideal background

You don’t need startup experience, but experience in areas like:

• Regulatory affairs (FDA / EMA)
• Clinical trial design
• Real-world evidence research
• Rare disease research
• Biostatistics or clinical data standards
• Pharmaceutical regulatory science

would be extremely valuable.

Commitment

This is a part-time cofounder role, expected to be a few hours per week initially while we explore the regulatory landscape and shape the platform’s evidence model.

Compensation would primarily be founding equity, with flexibility as the project evolves.

Why this might be interesting

There is growing interest in synthetic data and external control arms, but the regulatory credibility layer is still largely undefined.

The goal here is to explore how those approaches could responsibly integrate with existing clinical research frameworks.

Requirements

Requirements

Experience

• Advanced training or professional experience in regulatory science, clinical research, biostatistics, or pharmaceutical regulatory affairs
• Familiarity with FDA and/or EMA regulatory frameworks
• Experience with clinical evidence evaluation, trial design, or regulatory submissions
• Exposure to real-world evidence (RWE), observational studies, or rare disease research preferred
• Understanding of bias, confounding, and statistical validation in clinical datasets

Technical / Domain Knowledge

• Working knowledge of clinical trial methodology
• Familiarity with external control arms or synthetic cohort approaches (preferred but not required)
• Understanding of clinical data standards and governance
• Awareness of HIPAA, GDPR, and research data privacy considerations

Strategic Capabilities

• Ability to translate regulatory guidance into practical research or product frameworks
• Ability to identify risks in evidence credibility or regulatory acceptance
• Interest in shaping emerging approaches to synthetic or reconstructed clinical datasets

Collaboration

• Comfortable working with technical founders, data scientists, and researchers
• Ability to contribute part-time in an early-stage startup environment
• Strong written communication for white papers, validation frameworks, and regulatory discussions