Job Type
Full-time
Description
Senior Director, Medical Writing Location: Remote, US
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
Requirements
Preferred Education & Experience - Bachelor's degree in a life science required; advanced scientific or medical degree (e.g., MS, MPH, PhD, PharmD) strongly preferred
- 10+ years of regulatory medical writing experience in the biotechnology or pharmaceutical industry
- Lead-author experience on protocols, clinical study reports, and investigator brochures
- Medical writing experience across multiple regulatory filings at various stages of development
- Proficiency in the drug development process and strong understanding of health authority regulations, ICH guidelines, and medical writing standards, with the ability to apply them to document writing
- Excellent written and oral communication skills, with the ability to summarize complex scientific and clinical data concisely, accurately, and clearly
- Strong project management skills; able to work independently, manage multiple documents at once, and meet tight timelines
- Collaborative, detail-oriented, and responsive to feedback
Nice-to-Haves - Experience with EndNote, StartingPoint templates, and Veeva Vault
- Rare disease and/or oligonucleotide (siRNA, ASO) program experience
- Experience managing writing vendors or contractors
- Prior experience in a small or fast-growing biotech environment
- Curiosity and adaptability in adopting AI-enabled tools to improve clarity, speed, and quality of work
No matter your role at GondolaBio, successful team members are - Patient Champions, who put patients first and uphold strict ethical standards.
- Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset.
- Truth Seekers, who are detailed, rational, and humble problem solvers.
- Individuals Who Inspire Excellence in themselves and those around them.
- High-quality executors, who execute against goals and milestones with quality, precision, and speed.
What We Offer - Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts.
- A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak.
- An unyielding commitment to always putting patients first.
- A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science.
- A place where you own the vision - both for your program and your own career path.
- A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game.
- Access to learning and development resources to help you get in the best professional shape of your life.
- Robust and market-competitive compensation & benefits package (Base Salary, health, welfare & retirement programs).
- Flexible PTO.
- Rapid career advancement for strong performers.
- Potential ability to work on multiple GondolaBio Pharma programs across multiple therapeutic areas over time.
- Partnerships with leading institutions.
- Commitment to Diversity, Equity & Inclusion.
The base pay range for this position for the United States is $270,000-$280,000 per year. The actual compensation offered will be determined based on a number of job-related factors, including experience, skills, qualifications, and location.
Employees of BridgeBio and all affiliated companies should work through their managers to inquire about and learn more about this role.
Fraud Alert: We are aware of employment scams where individuals pose as representatives of GondolaBio and make false use of our company name to defraud job seekers. To protect yourself, please note that our official corporate website is https://gondolabio.com/ ; our careers page is https://gondolabio.com/#careers ; our LinkedIn page is https://www.linkedin.com/company/gondolabio/ . Please visit these links for official information from GondolaBio. Communication from any other variant is fraudulent. GondolaBio does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without interviews.
