Career Category

Job Description

Minimum Requirements:

• 6 or more years of clinical development experience, 4 years of which should be from a pharmaceutical or biotechnology company
• Clinical research experience
• Broad and formal leadership experience

Preferred Requirements:

• MD with oncology or hematology degree

Responsibilities:

• Provide leadership and strategic direction to the Affiliate TA staff
• Assist the IML in identifying and resolving clinical/scientific issues
• Perform portfolio level risk assessments and prioritization of programs
• Ensure alignment of early-stage strategy with late-stage TA objectives
• Approve Affiliate TA plans, goals, proposals and deliverables, including but not limited to protocols and SAP’s for local AST’s
• Chairs Affiliate TA Team meeting
• Foster and improve International collaboration and coordination
• Serve as a key interface to communicate Internationally and Locally important issues and status of programs to Amgen IRD and Affiliate Management
• Partner with the Affiliate Business Unit for all product lifecycle management activities
• Provide input, review, approve the Affiliate lifecycle management plan and ensure alignment across the portfolio
• Provide scientific/clinical oversight for the compilation of regulatory submissions across the portfolio
• Chairs the Local Development Team (LDT)
• Provide clinical oversight of product safety evaluation within the Affiliate TA
• Provide support and leadership for advisory boards
• Set Affiliate TA goals and dashboards to evaluate performance
• Ensure adequate resources and budget across all programs (study and non-study) and maintain budget accountability

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.