Director, Clinical Development: Inflammation & Fibrosis

Regulatory Jobs; Foster City (CA); On-site; USD 243,000 - 315,000; Full time

Job summary

Gilead is seeking a Director of Clinical Development (Non-MD) to lead or support multiple components of inflammation and fibrosis programs, including phase 3 data synthesis and global registration activities. The role focuses on medical monitoring, data analysis, and cross-functional leadership in a fast-paced biopharma environment.

The position requires a PharmD or PhD with 6+ years in drug development, strong regulatory and scientific expertise, and the ability to travel as needed.

Qualifications

• Basic Qualifications: PharmD or PhD in clinical research or clinical pharmacology with 6+ years of drug development experience.

Responsibilities

• Support or lead clinical development activities across assigned projects, including protocol preparation, study documentation, data analysis planning, study reporting, publications, and scientific presentations.
• Provide scientific and clinical guidance to cross-functional teams to support clinical development deliverables and timelines.
• Provide input into or lead development of Target Product Profile and Clinical Development Plan for assigned molecules or products.
• Provide ongoing medical monitoring for clinical trials, including eligibility assessment, toxicity management, and safety surveillance.
• Coordinate data collection and synthesis for internal analysis and review, and manage preparation of data listings and study results.
• Contribute to regulatory documents, investigator brochures, and development plans, and present scientific information at conferences.

Skills

Cross-functional leadership

Project management

Clinical data analysis

Regulatory submissions

Stakeholder communication

Education

PharmD or PhD in clinical research or clinical pharmacology

Job description

Gilead is seeking a Director of Clinical Development (Non-MD) to lead or support multiple components of inflammation and fibrosis programs, including phase 3 data synthesis and global registration activities. The role focuses on medical monitoring, data analysis, and cross-functional leadership in a fast-paced biopharma environment.

The position requires a PharmD or PhD with 6+ years in drug development, strong regulatory and scientific expertise, and the ability to travel as needed.