Medical Sciences Director - Late Development, Blincyto

Join Amgen's mission of serving patients. At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

In this vital role you will contribute to late phase clinical development of oncology. You will collaborate on teams to define, design, and deliver late phase clinical results, supplemented by translational projects in the ongoing strategy for drug development. Through your role, you will provide subject matter expertise in clinical and translational trial science as well as the biology and treatment of cancer.

You will 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 that may arise
• Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams
• Provide guidance and assistance in the identification and management of oncology collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects
• 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
• Provide clinical input into and implementation of clinical trial(s), their delivery, clinical data review, interpretation of results. 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 and integrity throughout the trial lifecycle

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

• Doctorate degree and 4 years of life sciences/healthcare experience
• OR Masters degree and 7 years of life sciences/healthcare experience
• OR Bachelors 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 oncology clinical trial process improvement
• Industry or academic experience in late-phase oncology drug development
• Strong communication and presentation skills to clearly communicate scientific concepts and data to leadership committees both internally or externally (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, database 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

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive…