Senior Director, Medical Writing

Description

This is a newly created position and a foundational hire for Agomab's Medical Writing function. The Sr. Director, Medical Writing will serve as the anchor of our hybrid medical writing model — working embedded across all clinical programs, owning narrative strategy and document quality, managing CRO medical writing relationships, and building the institutional knowledge and processes that will scale with the pipeline into Phase
3. This role will also lead how AI-assisted tools are adopted and applied within the medical writing function, balancing efficiency gains with the accuracy, compliance, and audit-trail standards regulatory documents require.

This is not a document production role. You will be expected to think and operate as a strategic partner with cross-functional stakeholders including Regulatory Affairs, Clinical Development, Clinical Operations, Biostatistics, and Pharmacovigilance and other stakeholders, shape how documents tell the program development story, and establish the standards and tools that define how medical writing works at Agomab.

• Author and lead the development of core regulatory and clinical documents across all programs, including clinical study protocols (Phase 1–3), clinical study reports (ICH E3), investigator's brochures, regulatory agency briefing documents (FDA Type C/D, EOP2, PreIND), scientific advice packages (e.g., MHRA, EMA), and pediatric plans (PIP/iPSP)
• Own the narrative strategy for each document — not just execution — ensuring scientific accuracy, internal consistency, and alignment with the program's development strategy
• Author and edit IND/NDA/eCTD supporting documents including CTD Module 2/5 summaries, integrated summaries of safety and efficacy, and submission-ready clinical overviews as programs advance
• Establish and maintain documentation standards, templates, and best practices consistent with internal and external guidelines for regulatory documentation and submissions; drive innovative solutions to resolve issues
• Review regulatory, clinical, and safety documentation according to good documentation practices — evaluating organization, clarity, and scientific standards — to ensure consistency of content across the portfolio and compliance with worldwide regulatory requirements
• Support preparation of manuscripts and abstracts for peer-reviewed publications in collaboration with medical and clinical teams

• Build and maintain Agomab's medical writing template library, style guide, and standard operating procedures, ensuring documents are inspection-ready and submission-quality
• Serve as process owner and subject matter expert for regulatory documentation; lead the development of training and resources for writers and cross-functional partners regardless of reporting relationship
• Maintain current awareness of applicable regulatory guidelines (ICH E3, E6, E8, E9; FDA and EMA guidance; CTD/eCTD specifications; global disclosure requirements) and proactively apply updates to documentation standards
• Ensure consistent entry of data to support departmental metrics and analytics; define and track KPIs to evaluate impact on cycle time, quality, and operational efficiency
• Interface across multiple functions to influence regulatory documentation processes, mediate conflict resolution, and champion a culture that promotes meaningful collaboration and superior document quality

• Serve as the internal anchor and quality steward for all CRO medical writing engagements — select, brief, oversee, and review work from external writers
• Assess resource requirements across all projects; assign resources according to R&D priorities; prepare criteria and…