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Executive Director, Clinical Development – MD
Gilead Sciences. Lead a portfolio of clinical trial programs in cell therapy clinical development .
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Lead a portfolio of clinical trial programs in cell therapy clinical development
- Oversee the design, conduct, evaluation, close-out, and reporting of clinical trials
- Lead and direct clinical development strategies, including Target Product Profiles and Clinical Development Plans
- Develop, implement, and oversee strategies for assigned molecules/products with cross-functional leaders and teams
- Represent assigned products in cross-functional steering and governance committees
- Lead or oversee clinical trial protocol design and clinical study reporting
- Lead written and oral communications with health authorities
- Provide or oversee medical monitoring, including eligibility assessment, toxicity management, and drug safety surveillance
- Lead or oversee clinical development components of regulatory documents, investigator brochures, and development plans
- Oversee ongoing data collection, internal analysis, data listings, summary tables, study results, and scientific presentations
- Present scientific information at conferences and investigator meetings
- Lead authorship of scientific publications where applicable
- Assist in clinical evaluation of business development opportunities
- Develop thought leader and external relationships to guide clinical development strategies
- Ensure adherence to GCP, ICH guidelines, internal SOPs, and industry standards
- Typically manage a team of direct reports
- Create inclusion, develop talent, and empower teams
Requirements
What you’ll need- MD/DO and 8+ years of clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia, or a related environment
- Board certification in hematology and/or medical oncology is preferred
- Familiarity with clinical oncology
- Biopharma industry experience, including submissions and conducting Phase 2–3 late development studies, is strongly preferred
- Experience in the multiple myeloma disease area and cellular therapy therapeutic area is strongly preferred
- Extensive experience leading high-complexity cross-functional drug development strategies and plans
- Experience with short- and long-range strategic planning, governance, and oversight
- Multiple years of line management/direct reports experience is preferred
- Experience interacting with and presenting to executives and managing large-scale budgets and resources is strongly preferred
- Proven track record of achieving or exceeding large-scale, complex short- and long-range strategies
- Expert-level knowledge of drug development
- Thorough understanding of pharmaceutical regulatory requirements and their impact on clinical trial development and execution
- Excellent communication and organizational skills
- Ability to distill complex matters into a clear business case and roadmap for execution
- Ability to align leaders and garner commitment and engagement for cross-functional strategies, plans, and objectives
- Ability to travel when needed
Benefits
Comp & perks- Discretionary annual bonus
- Discretionary stock-based long-term incentives (eligibility may vary based on role)
- Paid time off
- Company-sponsored medical insurance
- Company-sponsored dental insurance
- Company-sponsored vision insurance
- Company-sponsored life insurance