Executive Director, Medical Writing

What You’ll Do
- Establish and manage the Medical Writing group for the Cardiorenal affiliates (currently includes Eidos Therapeutics and Calcilytix) at BridgeBio.
- Oversee the development and finalization of clinical and regulatory documents including INDs, briefing documents, NDA/MAA summaries, regulatory responses, and key clinical documents (e.g., protocols, clinical study reports, investigator brochures).
- Direct, plan, author, review, and coordinate internal and external Medical Writers to prepare high-quality documents.
- Manage and develop staff to build strategic, scientific, and technical expertise; oversee vendors/contractors used to complete projects.
- Support multiple Cardiorenal clinical development programs.
- Report to the VP of Regulatory Affairs.

Responsibilities
- Oversee the Cardiorenal Medical Writing group (leading, training, mentoring).
- Lead medical writing for clinical study documents from concept to final product (protocols and forms, protocol amendments, CSRs, investigator brochures, related documents).
- Provide strategic leadership to study teams for protocols/CSRs, submissions, and associated public disclosure documents.
- Lead medical writing for regulatory submissions (IND applications, health agency interaction meeting requests, briefing documents, NDA/MAA data modules, submission packages for initial/supplemental applications).
- Ensure deep knowledge of regulatory writing and data disclosure requirements.
- Ensure SOPs/templates for document development and deliverables conform with regulatory requirements (e.g., ICH); take ownership of document processes.
- Partner with clinical development, biostatistics, and data management on TFLs and case narrative planning.
- Ensure clinical documents accurately reflect TFLs and other data sources.
- Project manage document review, clarifying conflicting/ambiguous comments in a timely manner.
- Ensure documents are submission-ready and properly archived in the document management system.
- Perform and respond to documented quality control (QC) checks; recommend quality process improvements.
- Establish medical writing support models and improve operational efficiencies (process initiative and/or vendor management).

Who You Are (Qualifications)
- Post-graduate scientific/medical degree (e.g., MS, MPH, PhD, PharmD, MD, DO) and 10+ years as a regulatory medical writer in biotechnology/pharmaceutical industry.
- Experience with medical writing for multiple regulatory filings across development stages.
- Experience managing consultants and their projects.

Required/Preferred Skills
- Excellent oral and written communication; ability to summarize and present complex scientific/clinical data clearly.
- Proficient in drug development process; strong understanding of health authority regulations, ICH guidelines, and medical writing standards.
- Excellent interpersonal, active listening, and influencing skills.
- Strong project management; ability to work independently, multi-task, and work under pressure.
- Preferred: EndNote, StartingPoint templates, Veeva Vault.
- Demonstrated curiosity/adaptability adopting AI-powered tools and technologies.

Where You’ll Work
- Hybrid role requiring in-office collaboration 2–3x per week (San Francisco, CA & Palo Alto, CA offices), or as needed.