Director of Clinical Development – Expert Consultant

About the role

We are seeking an experienced Director of Clinical Development to collaborate with a leading AI lab. You will train a language model on professional clinical documentation, spreadsheets, and slide decks, ensuring high‑quality outputs that meet regulatory standards.

Key responsibilities

• Create, evaluate, and refine AI‑generated clinical study reports, protocol synopses, investigator brochures, and regulatory dossier modules.
• Develop and review medical affairs slide decks and publication plans.
• Provide expert feedback on document structure, data presentation, and compliance with ICH‑GCP, FDA, and EMA expectations.
• Work flexibly 5–20 hours per week (or more) on a remote basis.

Required profile

• 5+ years of experience in clinical research, biomedical science, or pharmaceutical/regulatory affairs.
• Direct experience authoring or reviewing clinical study reports, protocol synopses, or regulatory dossier modules for pharma, biotech, or CRO organizations.
• Deep familiarity with ICH‑GCP standards and FDA/EMA regulatory expectations.
• Excellent written communication and meticulous attention to detail.

Required skills

• Regulatory dossier modules
• Clinical Study Reports
• Medical affairs materials
• EMA regulatory expectations
• Slide craftsmanship
• Investigator brochures
• Protocol synopses
• ICH‑GCP standards

What we offer

• Competitive compensation at $100 per hour.
• Fully remote work with flexible scheduling.
• Opportunity to shape cutting‑edge AI tools for the clinical development sector.