Senior Director, Medical Writing

JOB TITLE:

Senior Director, Medical Writing

LOCATION:

Boston, MA

DATE PREPARED:
September 15, 2026

The Senior Director, Medical Writing is responsible for the development and execution of medical writing deliverables that support AVEO Oncology's clinical development and regulatory writing portfolio. This individual is recognized as a scientific contributor and subject matter expert in the preparation of regulatory and clinical documentation and provides strategic medical writing leadership across assigned clinical programs. The incumbent is responsible for the efficient preparation of high-quality, scientifically accurate, and strategically aligned medical writing deliverables that support clinical development, clinical safety, and regulatory requirements.

The Senior Director will partner cross-functional to ensure key scientific and strategic communication points are effectively conveyed and are consistent across program documentation.

The incumbent will provide strategic oversight as well as hands-on support for critical medical writing deliverables and will contribute to the development and maintenance of medical writing best practices, processes, templates, and SOPs.

• Responsible for the planning, development, authoring, review, and finalization of clinical and regulatory documents, including clinical study protocols and amendments, clinical study reports (CSRs), Investigator's Brochures (IBs), regulatory briefing documents, clinical summaries and overviews, responses to health authority questions, and other documents supporting global regulatory submissions
• Provides strategic medical writing leadership and develops document strategies in collaboration with Clinical Development, Regulatory Affairs, Clinical Operations, Biostatistics, Data Management, Pharmacovigilance/Safety, and other cross-functional stakeholders
• Is recognized as a scientific contributor and subject matter expert in the preparation of regulatory and clinical documentation
• Applies knowledge of regulatory medical writing, clinical development, and oncology to support clinical programs across multiple stages of development
• Represents Medical Writing on cross-functional clinical development and regulatory teams and provides strategic guidance regarding document content, messaging, timelines, and regulatory requirements
• Ensures scientific data, key messages, terminology, and communication points are accurate and consistent across program documentation
• Interprets and synthesizes complex clinical, scientific, and statistical information into clear, concise, scientifically rigorous documents
• Leads medical writing activities supporting IND/CTA submissions and other global regulatory submissions and contributes to NDA/BLA/MAA submission activities, as applicable
• Partners with Regulatory Affairs and Clinical Development to anticipate future documentation requirements and ensure medical writing activities are aligned with program and submission timelines
• Leads or contributes to publication planning and execution, including abstracts, posters, oral presentations, manuscripts, and other scientific communications
• Collaborates with internal and external authors to develop publication content that appropriately communicates the scientific significance and clinical relevance of study results
• Understands the oncology publication landscape, including relevant journals, congresses, audiences, and publication practices, and advises internal teams and authors accordingly
• Ensures alignment of publication content with scientific communication objectives, program strategy, and approved terminology
• Manages outsourced medical writing projects and external vendors to ensure quality, strategic alignment, timely completion, and…