Sr. Director, Clinical Medical Writing

Scorpion Therapeutics; San Carlos (CA); Hybrid; USD 180,000 - 275,000; Full time

Benefits offered by this job

Hybrid remote work

Travel opportunities

Job summary

Scorpion Therapeutics in San Carlos, CA is seeking a Director of Clinical Medical Writing to lead the development and management of regulatory clinical documents for vaccine candidates in a fast-paced biotech setting.

You will oversee medical writing processes, manage contract writers, produce protocols, IBs, informed consent forms, and CSRs, and ensure GxP compliance for global submissions. Hybrid remote work with some travel is offered.

Qualifications

• Ph.D. or PharmD with 12+ years' experience in clinical research or biotech, especially vaccine development.
• Strong expertise in clinical development processes, GxP, and regulatory document management.
• Experience with global regulatory submissions and vendor management.

Responsibilities

• oversee medical writing processes
• manage contract writers
• generate key documents like protocols, IBs, informed consent forms, and CSR
• develop SOPs and templates
• ensure compliance with global regulatory standards
• support BLA/NDA submissions
• collaborate with cross-functional teams
• manage timelines and budgets

Skills

Regulatory writing leadership

Project management

Stakeholder collaboration

Education

Ph.D. or PharmD

Tools

Veeva Vault

Microsoft Office

AI writing tools

Job description

Director of Clinical Medical Writing

Role: Director of Clinical Medical Writing responsible for leading the development and management of regulatory clinical documents for vaccine candidates in a fast-paced, biotech environment.

Responsibilities

• oversee medical writing processes
• manage contract writers
• generate key documents like protocols, IBs, informed consent forms, and clinical study reports
• develop SOPs and templates
• ensure compliance with global regulatory standards
• support BLA/NDA submissions
• collaborate with cross-functional teams
• manage timelines and budgets

Requirements

• Ph.D. or PharmD with 12+ years' experience in clinical research or biotech, particularly in vaccine development (Phases I-IV, post-marketing), with proven leadership in regulatory document authorship and management
• Strong expertise in clinical development processes, GxP compliance, and experience with Veeva Vault, Microsoft Office, and emerging AI writing tools is preferred
• High-value specifics: vaccine modality, clinical phases, US and international regulatory submissions, and experience managing vendor relationships

Location: San Carlos, CA or remote with hybrid work arrangement; some travel may be required.