Clinical Scientist Director, Late Development GU Oncology Full-time

Clinical Scientist Director – Late Development, Gu Oncology

Let's do this. Let's change the world. In this vital role, the Clinical Scientist Director will support late-phase clinical development by translating scientific and clinical strategy into actionable execution across clinical trials. The Clinical Scientist serves as a key clinical development team member, providing hands-on oversight of protocol execution, medical data review, and clinical data quality to enable high-quality, decision-ready data. The Clinical Scientist works collaboratively within cross-functional teams to ensure clinical trials are executed in alignment with protocol intent, regulatory expectations, and Amgen quality standards.

• Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, with a strong focus on protocol execution and data integrity.
• Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues.
• 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 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 & implementation of clinical trial(s), delivery, clinical data review, and 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.

Basic Qualifications:

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

Preferred Qualifications:

• 5 years of pharmaceutical clinical drug development experience
• Strong preference for individuals with proven track record of clinical trial process improvement
• Industry experience in late-phase drug development for oncology (prostate-specific experience is a plus)
• 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 clinical trials for oncology 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

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.

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.