Senior Director, Medical Writing

Senior Director, Medical Writing

Location: Remote, US

About GondolaBio

GondolaBio is a clinical-stage biopharmaceutical company focused on developing breakthrough therapeutics for genetic diseases. GondolaBio is an independent sister company to BridgeBio, originally carved out in 2024 after securing $300M in private financing from external investors. GondolaBio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases.

Who You Are

You are a seasoned regulatory medical writing leader who takes clinical and regulatory documents from first draft to final, submission-ready version. You have authored and led the preparation of key documents that move programs forward — protocols, investigator brochures, clinical study reports, IND applications, briefing documents, and submission modules — and you know health authority guidance and public disclosure requirements well enough to apply them with judgment, not just by checklist. You work well with study teams, keep reviews moving, resolve conflicting comments, and make sure every message in a document is supported by the data. You are comfortable owning your documents end to end in a small, fast-moving company, and you are ready to take on more as our programs grow. You influence without authority, bring clarity to complex data, and see process improvement and vendor management as core parts of the job.

The ideal candidate has:

• Led medical writing from concept to final product for clinical and regulatory documents across multiple development stages, including IND/CTA components
• Authored clinical documents such as protocols, amendments, investigator brochures, and clinical study reports as the lead writer
• Worked closely with clinical development, biostatistics, and data management to interpret tables, figures, and listings (TFLs)
• Managed document timelines and review cycles across cross-functional teams
• Managed external medical writing vendors and consultants to deliver high-quality, submission-ready documents on time
• Owned document standards, templates, SOPs, and QC processes aligned with ICH and relevant regulatory guidelines

Key Responsibilities

Clinical Documents

• Author and lead development of clinical study protocols and amendments, clinical study reports, investigator brochures, and related clinical study documents from concept to final product
• Partner with clinical development, biostatistics, and data management on the review of tables, figures, and listings (TFLs) and on case narrative planning
• Ensure results and key messages in clinical documents accurately reflect the data in TFLs and other data sources
• Prepare associated public disclosure documents, such as clinical trial registry postings and results summaries
• Provide oversight of vendors and contractors engaged for medical writing deliverables

Regulatory Submissions

• Lead medical writing for regulatory submissions, including IND applications, health authority meeting requests and briefing documents, responses to health authority questions, and future NDA/MAA clinical modules and submission packages
• Bring in-depth knowledge of regulatory writing and data disclosure requirements to every submission

Quality & Process

• Ensure documents follow agreed internal processes, are submission-ready, and are appropriately archived in the document management system
• Perform and coordinate quality control (QC) checks on medical writing deliverables and address findings
• Suggest improvements to templates and document preparation processes

Review Management & Collaboration

• Serve as the Medical Writing point of contact for clinical, regulatory, biostatistics, clinical pharmacology, and translational teams
• Project manage document timelines and review cycles, ensuring conflicting or ambiguous comments are clarified and addressed in a timely, efficient manner