Medical Sciences Director - Late Development Oncology

October 1

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Amgen

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Biologics • Human therapeutics • Development of novel products

10,000+

💰 Post-IPO Debt on 2022-12

Description

• In this vital role you will contribute to late phase clinical development of oncology. • Collaborate on teams to define, design, and deliver late phase clinical results. • Provide subject matter expertise in clinical and translational trial science as well as the biology and treatment of cancer. • Contribute intellectual insight into experimental design and data analysis. • 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, anticipating and actively managing problems. • Provide guidance and assistance in the identification and management of oncology collaborators, consultants, and/or Clinical Research Organizations (CROs). • Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents. • Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval. • Review and analyze clinical trial data to ensure accuracy, completeness and adherence to protocol and regulatory requirements. • Conduct thorough data quality assessments in the context of a data monitoring plan to maintain high standards of data accuracy.

Requirements

• Doctorate degree and 4 years of medical science experience OR Master’s degree and 7 years of medical science experience OR Bachelor’s degree and 9 years of medical science experience. • 5 years of pharmaceutical clinical drug development experience preferred. • Strong preference for individuals with a consistent track record of 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. • Experience with designing, monitoring, and implementing oncology clinical trials and interpreting test results in compliance with Good Clinical Practice standards. • 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

• 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. • A sales-based incentive plan for field sales representatives. • Stock-based long-term incentives. • Award-winning time-off plans and bi-annual company-wide shutdowns. • Flexible work models, including remote work arrangements, where possible.