Amgen

Global Study Planner

Employer
Amgen
Location
Thousand Oaks, CA
Posted
Aug 20, 2019
Ref
R-81718
Required Education
High School or equivalent
Position Type
Full time
Job Summary

The Global Study Planner will independently execute Demand and Supply Planning processes for dedicated global clinical studies. This role will ensure Finished Drug Product (FDP) supply from study start through last patient dosed and is involved until study closure. This individual will coordinate efficient and effective operational inventory management as well as ensure sufficient FDP supply while minimizing scrap during the full length of the study.

Under general direction of the Senior Manager, this role will manage the following responsibilities for assigned clinical studies for medium or complex study designs or large sized trials.

Responsibilities:
  • Based on demand at the clinical sites and available supplies that hit an expiry date, ensure supply in the central warehouses and all sites that participate in the clinical trial. Indicate ratio, volume and timing of packaging and shipment of packed supplies.
  • Balance the right amount of inventory with the scrap risk utilizing management guidance regarding inventory levels.
  • Resolve logistical conflicts impacting studies and R&D milestones ensuring that supplies are not on the critical path.
  • Promptly identify and escalate risks to study timelines or clinical supplies, from a supply chain perspective, to all key stakeholders and internal management.
  • Utilize systems to effectively manage key product such as the Forecasting system, SAP, Hospital inventory and dosing systems. Utilize dashboard controls and internal documents as a source for daily activities.
  • Articulate clearly the clinical supply chain management processes and strategies to key stakeholders.
  • Identify, review and/or update existing procedures as per Good Manufacturing Procedures.
  • Negotiate resolution of resource conflicts where necessary and actively participate in planning meetings to ensure that project needs, priorities, and timing are understood.
  • Host meetings to identify, address and resolve issues.
  • Maintain prerequisite data files, metrics, and forecasts in specific operating platforms to ensure satisfactory product inventory and timeline shipments.
  • Prepare and facilitate drug forecast conversations and adjust system settings in a timely manner to reflect the latest expectations on study demand until end of trial. This includes attending and leading stakeholder meetings.
  • Manage shelf life and expiry.
  • Manage the destruction of expired and unused DP inventory.


Basic Qualifications

Master's degree

OR

Bachelor's degree and 2 years of experience in Operations/Life Science industry/supply chain

OR

Associate's degree and 6 years of experience in Operations/Life Science industry/supply chain

OR

High school diploma / GED and 8 years of experience in Operations/Life Science industry/supply chain

Preferred Qualifications
  • Knowledge of end-to-end supply chain, drug development, and manufacturing processes
  • Experience in applying Process Improvement and Analysis tools, Root Cause Analysis, Standard Work and Daily Management Systems
  • Ability to communicate and collaborate across various parts of the organization
  • Function effectively on a team whose members together provide leadership, create a collaborative and inclusive environment, establish goals, plan tasks, and meet objectives
  • Ability to operate in a matrixed team and dynamic environment
  • Adept in breaking down complex issues into concise analytical packages and executive messages to enable prompt decision making
  • Quantitative and qualitative skills in supply chain analysis
  • Ability to analyze and interpret data, and use judgment to draw conclusions
  • Ability to manage two to three projects simultaneously while consistently delivering quality end-product. Handle multiple responsibilities, priorities and tasks with minimal direction
  • Strong interest in learning new things, ability to take on tasks with limited information and/or guidance. Must be able to learn and become proficient in Analytics and Supply Management tools including ANAPLAN, SAP, and CDOCS


Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.

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.