Oncology Clinical Development Director
hace 3 semanas
At Gilead Sciences, we're driven by a passion to improve lives. Our dedication to innovation has led us to become a leading innovator in the field of virology, with a strong focus on oncology. As a key member of our team, you'll play a critical role in shaping our clinical development strategy.
In this role as Regional Clinical Development Director, you'll lead regional components of clinical trial programs in Oncology clinical development. Your key responsibilities will include medical monitoring, study design, and clinical development planning. You'll work closely with global teams to provide strategic input and ensure seamless execution.
**Key Responsibilities**:
- Provides input into or leads the regional development of the Target Product Profile and Clinical Development Plan for assigned molecules/products.
- Provides scientific and clinical guidance to cross-functional teams and colleagues to meet regional clinical development project deliverables and timelines.
- Provides input into, or otherwise leads, clinical trial protocol design, clinical study reports, and health authority inquiries.
- Manages the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures, and development plans.
- Coordinates and manages the preparation and/or review of data listings, summary tables, study results, and scientific presentations.
**Requirements**:
- PharmD, PhD, or MSC degree in clinical research or clinical pharmacology with significant drug development experience in the biopharma industry.
- MD with board certification in Oncology is highly desirable, including familiarity with clinical oncology medicine.
- Significant experience working on, with, and leading cross-functional project/program teams in biopharma.
- Fluency in English and either Spanish or Portuguese is essential.
**What We Offer**:
- Opportunities for professional growth and development.
- Collaborative and dynamic work environment.
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