Director, Medical Writing

The Director Medical Writing will lead narrative strategy and document quality across clinical programs, oversee CRO medical writers, and build scalable processes for the pipeline's progression into Phase 3. The role will also lead AI-assisted tools and workflows, establishing appropriate controls for human oversight, traceability, accuracy, confidentiality, validation, and quality.

This hands-on leadership role combines document development with strategic cross-functional partnership. The Director will shape how documents communicate the program story and help define Agomab's medical writing standards, processes, and tools.

• Document authorship and narrative strategy
• Lead the authorship and narrative strategy of clinical and regulatory documents, including protocols, study reports, investigator's brochures, agency briefing packages, and pediatric plans.
• Author and edit IND/NDA/eCTD content, including CTD Module 2/5 summaries, clinical overviews, and integrated safety and efficacy summaries.
• Ensure documents are clear, scientifically accurate, consistent, compliant, and submission-ready.

• Documentation standards and process ownership
• Develop and maintain medical writing standards, templates, SOPs, style guidance, training, and resources.
• Keep practices aligned with current ICH, FDA, EMA, CTD/eCTD, and disclosure requirements.
• Use quality, cycle-time, and efficiency metrics to improve documentation processes and collaboration.

• CRO and external medical writing management
• Plan medical writing resources and recommend the right mix of internal and external support.
• Select, brief, oversee, and quality-check CROs and external writers.
• Manage external deliverables against program milestones and submission timelines.

• AI and Technology
• Evaluate, pilot, and implement AI-assisted and automation use cases for medical writing.
• Establish controls for risk, human oversight, source traceability, verification, confidentiality, validation, change management, and quality.
• Develop approved workflows, reusable prompts, and practical training that support responsible adoption.

• Cross-functional collaboration and planning
• Partner with Regulatory Affairs, Clinical Development, Clinical Operations, Biostatistics, Pharmacovigilance, and other stakeholders.
• Plan documents, coordinate inputs and review cycles, resolve issues, and drive timely completion.
• Contribute to the scaling of medical writing through capacity planning and effective resourcing models.

• Bachelor's degree in a life science, medical, or related discipline; an MS, PharmD, or PhD is preferred.
• At least 10 years of regulatory medical writing experience in the pharmaceutical or biopharmaceutical industry, including independent authorship of Phase 1-3 documents.
• Strong direct experience with protocols, clinical study reports (ICH E3), investigator's brochures, and regulatory agency briefing documents.
• Experience authoring or leading IND/CTA and eCTD supporting documents, including CTD Module 2/5 summaries and integrated safety and efficacy summaries.
• Thorough knowledge of global regulatory requirements, CTD/eCTD standards, disclosure requirements, drug development, and clinical trial processes.
• Hands-on experience evaluating, implementing, or governing AI-assisted or automation tools in a medical writing or regulatory setting.
• Ability to lead cross-functional initiatives, manage multiple programs and deadlines, work independently, exercise sound judgement, and escalate appropriately.
• Clear, collaborative communication skills and experience partnering with Regulatory Affairs, Clinical Development, Clinical Operations, Biostatistics, and Pharmacovigilance.
• Preferred: experience in GI or respiratory indications, inflammation or fibrosis; CRO oversight; Veeva Vault, Please Review, or equivalent; pediatric plans; publications; or an early-stage biotech environment.

• The role may be based in the US or EU, with an East Coast US location considered a plus. Remote and flexible working, with periodic travel to Belgium, Boston, and key program meetings.
• A high-impact role in an ambitious, innovation-driven biotech company.
• Direct involvement in pioneering therapies for unmet medical needs.
• A collaborative, agile and fast-paced environment.
• Competitive salary and benefits.