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Iambic Therapeutics, a clinical-stage biotech company leveraging AI-driven discovery and development platforms, seeks an experienced Principal Medical Writer to independently author and oversee high-quality, submission-ready regulatory documents supporting clinical programs and IND submissions.
Reporting to the Head of Medical Writing, you will partner with cross-functional teams—Clinical, Nonclinical, Medical, Biostatistics, CMC, and Regulatory—to advance the company's mission of delivering differentiated, patient-optimized therapeutics. This is a high-impact individual contributor role in a fast-moving organization.
Key responsibilities include:
- Planning, authoring, and delivering submission-ready documents (protocols, Investigator's Brochures, DSURs, Clinical Study Reports, INDs, Health Authority responses, briefing documents)
- Leading cross-departmental document development and representing medical writing on internal study teams and working groups
- Supporting development of abstracts, posters, and presentations for scientific conferences
- Establishing and refining medical writing processes, templates, and standards to ensure consistency and quality
- Evaluating and integrating AI-enabled tools to improve writing quality and efficiency
Required qualifications:
- Bachelor's degree in life sciences or health-related field; advanced degree (Masters/PhD/PharmD) preferred
- Minimum 10 years of relevant medical writing experience
- Demonstrated experience with IND submissions and clinical-stage program documentation
- Strong FDA/EMA regulatory knowledge and ICH guideline familiarity
- Excellent scientific writing, communication, and organizational skills
- Proficiency in Microsoft Office (especially Word) and electronic document/reference management systems
- Aptitude for learning and adopting new technologies, including AI tools
- Ability to thrive in fast-paced, collaborative environments
Iambic, founded in 2020 and based in San Diego, has assembled a world-class team combining AI expertise with drug development experience. The platform has demonstrated delivery of new drug candidates to human clinical trials with unprecedented speed across multiple target classes. The company offers competitive compensation, company-paid healthcare, 401K matching, uncapped vacation, and operates from a state-of-the-art facility with onsite gym and dining.
