Clinical Scientist Associate Director Late Development, Oncology

Letsdo the this rolethe Clinical Scientist Associate Director supports late-phase clinical development by contributing toprotocol development study start up data review and monitoring and analysis collaboratively with the study team and clinical leadership this role focuses on study-level implementation and cross-functional coordination to help ensure high-quality decision-ready clinical data.

Key Responsibilities:

• Support set up and execution of late phase clinical trials with a focus on data quality

• Assistin authoring clinical protocols Investigators Brochures and other regulatory documents ensuring consistency and clarity

• Provide input into & implementation of data management plan CRF design and data review oversight

• Support review analysis and presentation preparation of clinical trial data for internal decision making external interactions and regulatory submission

• Assists Development Lead and Medical Sciences Director in medical monitoring and managementofcollaborators consultants and/or Clinical Research Organizations in completion of key projects

• Anticipate and actively manage problems across a broad spectrum of cross-functional teams

• Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document studyprotocoland related documents

• Supportappropriate training recruitment and development requirements for matrix team resources

WIN

WHAT WE EXPECT OF YOU

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

Minimum Requirements

• Doctorate degree and3years of life sciences/healthcare experienceOR
• Masters degree and5years of life sciences/healthcare experienceOR
• Bachelors degree and7years of life sciences/healthcare experience

Preferred Requirements

• 3years of pharmaceutical clinical drug development experience

• Demonstrated experience contributing to clinical trial process improvements within a therapeutic area or study team environment

• Industry or academic experience supporting early or late-phase drug development within a relevant therapeutic area or diseaseindication

• Strong communicationand presentation skills in English with the ability to clearly convey scientific concepts and clinical data to cross-functional teams and leadership audiences both written and oral

• Experience supporting the design monitoring and implementation of clinical trials in compliance with Good Clinical Practice standards and applicable regulatory requirements

• Working knowledge of study data readout activities including data cleaning database lock data extraction and generation of clinical data outputs

• Experience contributing to regulatory submission documents and supporting clinical regulatory responses for health authority interactions under guidance

• Experience serving as a contributing author on scientific publications or data presentations for internal forums or scientific conferences

• Experience in clinical data analysis such as Spotfire or other data analysis tools

THRIVE

WHAT YOU CAN EXPECT OF US

As we work to develop treatments that take care of others we also care deeply for our teammates well-being and growth.

• Vast opportunities to learn develop and move up and across our global organization.

• Diverse and inclusive community of belonging where colleagues are empowered to bring ideas to the table take risks and act.

• Generous AMGEN Total Rewards Plan comprising healthcare finance wealth and career benefits.

• Flexible work arrangements.

Objects in your future are closer than they us.

EQUAL OPPORTUNITY STATEMENT

AMGEN is an Equal Opportunity employer and will consider you without regard to your race color religion sex sexual orientation gender identity national origin protected veteran status or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process to perform crucial job functions and to receive other benefits and privileges of employment. Please contact us to request an accommodation.