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JOB SUMMARY The 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 RESPONSIBILITIES
- Lead 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 expectations
- Partner cross-functionally with Clinical, Nonclinical, Medical, Biostats, CMC, and Regulatory teams
- Establish and refine medical writing processes, templates, and standards
- Implement and manage efficient document workflows and timelines
- Support development of abstracts, posters, and presentations for scientific conferences
- Evaluate and integrate AI tools to enhance writing quality and efficiency
- Manage external vendors and contribute to building internal capabilities over time
- Ensure consistency, quality, and accuracy across all deliverables
- Advise cross-functional leadership on regulatory communication strategy and global document planning
QUALIFICATIONS
- Bachelor’s degree required; advanced degree (PhD, PharmD, MD) preferred
- 15+ years of experience in biotech/pharma, with 10+ years in medical writing, prior experience in smaller or growing biotech environments preferred
- Strong experience supporting IND submissions and clinical-stage programs
- Strong scientific writing and editing skills, with attention to detail
- Solid understanding of FDA/EMA regulations and ICH guidelines
- Ability to lead cross-functional document development in a lean environment
- Comfortable balancing strategic input with hands-on execution
- Interest in applying AI tools to improve medical writing workflows
About Iambic Therapeutics
Iambic 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 VALUES
Our 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 Benefits
We 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
KEY RESPONSIBILITIES
- Lead 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 expectations
- Partner cross-functionally with Clinical, Nonclinical, Medical, Biostats, CMC, and Regulatory teams
- Establish and refine medical writing processes, templates, and standards
- Implement and manage efficient document workflows and timelines
- Support development of abstracts, posters, and presentations for scientific conferences
- Evaluate and integrate AI tools to enhance writing quality and efficiency
- Manage external vendors and contribute to building internal capabilities over time
- Ensure consistency, quality, and accuracy across all deliverables
- Advise cross-functional leadership on regulatory communication strategy and global document planning
QUALIFICATIONS
- Bachelor’s degree required; advanced degree (PhD, PharmD, MD) preferred
- 15+ years of experience in biotech/pharma, with 10+ years in medical writing, prior experience in smaller or growing biotech environments preferred
- Strong experience supporting IND submissions and clinical-stage programs
- Strong scientific writing and editing skills, with attention to detail
- Solid understanding of FDA/EMA regulations and ICH guidelines
- Ability to lead cross-functional document development in a lean environment
- Comfortable balancing strategic input with hands-on execution
- Interest in applying AI tools to improve medical writing workflows
Pay And Benefits
We 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
