Head of Medical Writing
Job SummaryThe Head of Medical Writing (Senior Director) will lead and build the medical writing function, reporting to the VP of Regulatory. This role will be responsible for delivering high-quality submission-ready development documents to support ongoing clinical-stage programs and upcoming IND submissions, while establishing fit-for-purpose, scalable processes and standards.The ideal candidate is both strategic and hands-on, with the ability to drive document development and address global program objectives while also building infrastructure for future growth, including the thoughtful integration of AI-enabled tools.Key ResponsibilitiesLead the planning, authoring, and delivery of key development documents (INDs, protocols, IBs, CSRs, Health Authority responses, briefing documents, etc)Provide strategic input on document content, messaging, and regulatory expectationsPartner cross-functionally with Clinical, Nonclinical, Medical, Biostats, CMC, and Regulatory teamsEstablish and refine medical writing processes, templates, and standardsImplement and manage efficient document workflows and timelinesSupport development of abstracts, posters, and presentations for scientific conferencesEvaluate and integrate AI tools to enhance writing quality and efficiencyManage external vendors and contribute to building internal capabilities over timeEnsure consistency, quality, and accuracy across all deliverablesAdvise cross-functional leadership on regulatory communication strategy and global document planningQualificationsBachelor’s degree required; advanced degree (PhD, PharmD, MD) preferred15+ years of experience in biotech/pharma, with 10+ years in medical writing, prior experience in smaller or growing biotech environments preferredStrong experience supporting IND submissions and clinical-stage programsStrong scientific writing and editing skills, with attention to detailSolid understanding of FDA/EMA regulations and ICH guidelinesAbility to lead cross-functional document development in a lean environmentComfortable balancing strategic input with hands-on executionInterest in applying AI tools to improve medical writing workflowsAbout Iambic TherapeuticsIambic is a clinical-stage life-science and technology company developing novel medicines using its AI-driven discovery and development platform. Based in San Diego and founded in 2020, Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters. The Iambic platform has demonstrated delivery of new drug candidates to human clinical trials with unprecedented speed and across multiple target classes and mechanisms of action. Iambic is advancing a pipeline of potential best-in-class and first-in-class clinical assets, both internally and in partnership, to address urgent unmet patient need. Learn more about the Iambic team, platform, pipeline, and partnerships at iambic.ai.MISSION & CORE VALUESOur mission is to deliver better medicines through innovations in AI-based discovery technologies. The culture and work at Iambic Therapeutics are profoundly strengthened by the diversity of our people and our differences in background, culture, national origin, religion, sexual orientation, and life experiences. We are committed to building an inclusive environment where a diverse group of talented humans work together to discover therapeutics and create technologies.Pay And BenefitsWe offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life insurance, 401K matching, and uncapped vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.Compensation Range: $224K - $280K