Senior Director, Head of Regulatory & Medical Writing (Biotech)

Location: Brisbane, California, United States

Salary: $254,127–$289,388 annually, plus bonus and equity.

Company

hirify.global is a clinical-stage biopharmaceutical company developing targeted protein degradation medicines for cancer and inflammatory diseases using an AI-integrated discovery engine.

What you will do

• Lead regulatory and medical writing strategy for assigned clinical development projects and regulatory submissions.
• Allocate internal and external writing resources, manage contractors, and build an internal medical writing group as appropriate.
• Coordinate, author, review, and substantively edit protocols, clinical study reports, investigator’s brochures, IND materials, integrated summaries, risk management plans, and health authority responses.
• Lead writing deliverables for NDA, BLA, MAA, and eCTD submissions while maintaining timelines and quality standards.
• Support global transparency and disclosure deliverables, including plain-language summaries and regulatory document redactions.
• Partner with Clinical Science, Clinical Development, Medical, Regulatory, Biometrics, and other functions on document strategy, data presentation, and process improvement.

Requirements

• BS with 15+ years of oncology clinical research experience, or an MS or other advanced science degree with 10+ years of relevant experience.
• Experience leading a regulatory writing group and managing internal writers and external contractors.
• Expertise writing or leading critical clinical documents for NDA, BLA, and MAA submissions.
• Experience with Phase 1–3 oncology protocols, investigator’s brochures, clinical study reports, briefing packages, and health authority responses.
• Advanced knowledge of drug development, GCP, ICH Guidelines, US FDA regulations, regulatory guidance, style guides, medical dictionaries, and document management systems.
• Strong organization, documentation, communication, multitasking, and complex clinical data interpretation skills.

Nice to have

• Experience with Pediatric Investigational Plans (PIPs).

Culture & Benefits

• Cross-functional collaboration across clinical, regulatory, medical, biometrics, and development teams.
• Opportunity to establish and develop an internal regulatory and medical writing function.
• Compensation includes bonus and equity in addition to base salary.