Amgen
Biologics • Human therapeutics • Development of novel products
10,000+
💰 Post-IPO Debt on 2022-12
Medical Sciences Director - Late Development, Thoracic Oncology
17 hours ago
Amgen
Biologics • Human therapeutics • Development of novel products
10,000+
💰 Post-IPO Debt on 2022-12
Description
• Help define, design, and deliver late phase clinical results in oncology. • Provide subject matter expertise in clinical and translational trial science. • Serve as an internal clinical expert in translational and clinical oncology. • Support medical monitor in clinical trials and assist in resolving issues. • Present information internally and externally, • Provide guidance in the identification and management of oncology collaborators and CROs. • Ensure integrity of protocols and components of clinical plans. • Provide clinical input into implementation of clinical trials and data review. • Review and analyze clinical trial data for accuracy and completeness. • Conduct data quality assessments to maintain standards of data accuracy.
Requirements
• Doctorate degree and 4 years of life sciences/healthcare experience OR Master’s degree and 7 years of life sciences/healthcare experience OR Bachelor’s degree and 9 years of life sciences/healthcare experience • 5 years of pharmaceutical clinical drug development experience • Strong preference for individuals with proven track record of thoracic oncology clinical trial process improvement • Industry or academic experience in late-phase oncology drug development • Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externally (both written and oral) • Experience with designing, monitoring, and implementing oncology clinical trials and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements • Understanding of conducting study data readout activities, including data cleaning, data base lock, data extract, producing outputs of data • Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions • Serving as a contributing author to scientific publications and data presentations at scientific conferences • Experience in clinical data analysis such as Spotfire or other data analysis tools
Benefits
• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, • group medical, dental and vision coverage, • life and disability insurance, • flexible spending accounts • A discretionary annual bonus program, • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models, including remote and hybrid work arrangements, where possible
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