Clinical Development Director
3 hours ago
About the Role
The Director, Clinical Development Hepatitis will provide clinical leadership and input on clinical studies, supporting the hepatitis programs. This role will lead or assist on multiple components of clinical trial programs in Hepatitis clinical development, including design, conduct, and evaluation of Phase 1-4 clinical trials.
Key Responsibilities
- Provide scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
- Lead clinical trial protocol design, clinical study reports, and health authority inquiries, and provide ongoing clinical monitoring for clinical trials.
- Manage the clinical development component in the preparation and review of regulatory documents, investigator brochures, and development plans.
- Coordinate the collection and assimilation of ongoing data for internal analysis and review.
- Presents scientific information at scientific conferences and clinical study investigator meetings.
Requirements
- MD/DO with 4+ years of clinical or biotech/pharma industry experience, or PharmD or PhD in clinical research or clinical pharmacology with 8+ years' scientific and/or drug development experience.
- Experience in hepatitis D and/or B, and relevant experience in Hepatology is preferred.
- Strong communication and organizational skills, and ability to travel when needed.
About Gilead Sciences, Inc.
Gilead Sciences, Inc. is an equal opportunity employer committed to a diverse workforce. Employment decisions will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information, or other non-job related characteristics.
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