Executive Director, Medical Writing & Regulatory Strategy

Kyverna Therapeutics; United States; Hybrid; USD 275,000 - 300,000; Full time

Benefits offered by this job

Bonus eligible

Stock plan

Hybrid/Remote flexible work

Job summary

Kyverna Therapeutics in Emeryville offers an executive leadership role for Medical Writing. You will lead strategy, governance, and execution across the full product lifecycle, ensuring submission-ready, scientifically rigorous documents that support regulatory, development, and commercialization goals.

Reporting to the Chief Regulatory Officer, you will build and mentor a high-performing team, oversee global submissions (INDs, BLAs, MAAs), and partner with Regulatory Affairs, Clinical

Qualifications

• Advanced degree in life sciences, pharmacy, medicine, or related discipline.
• 12+ years of progressive medical writing experience in biotech/pharma.
• Experience leading medical writing for global regulatory submissions (INDs/BLAs/MAAs).
• Strong knowledge of FDA, EMA, ICH guidelines.

Responsibilities

• Lead Medical Writing strategy, governance, and capabilities across development lifecycle.
• Oversee planning, development, review, and delivery of regulatory and scientific documents.
• Collaborate with Regulatory Affairs, Clinical Development, and Quality to ensure submission readiness.
• Build and mentor a high-performing Medical Writing organization.

Skills

Leadership

Strategic medical writing

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Education

Advanced degree in life sciences, pharmacy, medicine, or related discipline (PhD/MD/PharmD preferred)

Job description

Kyverna Therapeutics in Emeryville offers an executive leadership role for Medical Writing. You will lead strategy, governance, and execution across the full product lifecycle, ensuring submission-ready, scientifically rigorous documents that support regulatory, development, and commercialization goals.

Reporting to the Chief Regulatory Officer, you will build and mentor a high-performing team, oversee global submissions (INDs, BLAs, MAAs), and partner with Regulatory Affairs, Clinical