Amgen

Senior Manager, Program Resource Management

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Feb 18, 2021
Ref
R-110742
Required Education
Bachelors Degree
Position Type
Full time

Title: Senior Manager, Global Clinical Program Management

GCF Level 6

Working title: Senior Manager, Program Resource Management

Role purpose:

• Oversee and manage GCPM Functional Service Provider performance and quality at a GCPM Hub Level
• Translate business strategy into effective resource planning and management within GCPM to support the delivery of the portfolio

• Identify and evaluate Hub Level Risk, ensuring effective mitigations and escalations are implemented

• Ensure GCPM FSP Vendor adherence to Amgen standards and all applicable regulations
• Drive strong collaboration between GCPM, Early Development and GSO-SM functions to support effective delivery of our clinical trials portfolio

• Support GCPM Training requirements and Role Forums

• Support continuous improvement initiatives in GCPM and their interactions with the wider Global Development Operations (GDO) function

Key activities:

• Lead the hiring and headcount management of FTE GCTM staff
• Strategic Leadership of the GCPM FSP Hub FMT and provide input into the GCPM FSP OMT forums
• Responsible for Quality Oversight of FSP GCPM vendors and Monitor of GCPM Hub Key Performance Indicators (KPI)
• Perform Staff Quality Assessments to support GCPM FSP model quality review
• Ensure effective Functional Management Team meetings are delivered monthly
• Manage PRM risk assessment and mitigation process and contribute to ongoing FSP risk assessment and risk mitigation program at a GCPM Hub Level
• Responsible for ensuring resolution of performance issues for a given GCPM Hub
• Support global best practice sharing between Hubs in GCPM model

• Support Head of Program Resource Management in planning and executing Hub Operating Reviews

• Partner and communicate effectively with key stakeholders regarding GCPM Hub performance

• Support GCPM functional goal setting process

• Support the onboarding activity alignment and plans for FTE and FSP staff within GCPM

• Support roll-out of new business process and initiatives to ensure consistent application by GCPM staff

Qualifications

• Batchelor's degree in related discipline

• BS/BA/BSc in the sciences or RN
• Proven work experience in life sciences or medically related field, including proven track record of biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company
• Previous management experience of direct reports
• Experience at or oversight of outside clinical research vendors (CRO's, central labs, imaging vendors, etc)

Knowledge
• Knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP), and applicable international regulations and guidelines
• Knowledge of international regulatory requirements
• Clinical Development process and procedures
• Project planning experience including oversight of study deliverables, budgets, and timelines
• Ability to use scientific and clinical knowledge to conceptualize study designs
• Experience anticipating and resolving problems
• Experience collaborating and leading cross-functional teams (team/matrix environment)
• Experience working internationally
• Excellent interpersonal, organizational, supervisory skills

• Excellent communication and critical thinking skills

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.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.