Obsidian Therapeutics

Medical Director

• Develop and execute the company’s medical writing strategy for clinical development, regulatory submissions, and launch readiness
• Partner with Regulatory Affairs on strategic alignment, submission readiness, messaging consistency, and regulatory compliance
• Translate complex clinical, statistical, safety, translational, and manufacturing information into clear scientific narratives
• Lead authoring, review, and finalization of BLA documents, Module 2 clinical summaries, Clinical Study Protocols, Investigator Brochures, CSRs, SAP summaries, ISS, ISE, and responses to health authority questions
• Collaborate with Clinical Development and Biometrics to construct evidence packages
• Serve as primary medical writing representative on cross-functional program and submission teams
• Drive alignment on scientific messaging, timelines, and review processes
• Establish document planning, governance, standards, templates, and quality systems
• Ensure consistency across protocols, SAPs, CSRs, safety documents, and regulatory summaries
• Contribute to inspection readiness and document traceability
• Establish efficient document development processes
• Build a scalable medical writing operating model and oversee contract writers, editors, and publishing vendors
• Identify risks, resource constraints, and submission-critical dependencies and implement mitigation plans
• Implement best practices for content reuse, document standards, authoring technologies, and quality control
• Develop and maintain writing templates, style guides, and document repositories
• Ensure compliance with ICH, GCP, FDA, EMA, and company quality requirements

Director, Medical Writing