Join Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Clinical Study Planning ManagerWhat you will doLet’s do this! Let’s change the world!Development Supply Chain (DSC) is responsible for the end-to-end delivery of products, process knowledge and technology solutions to enable Amgen’s accelerate product commercialization. DSC serves as a launch site to enable speed to market for the company's innovative products and biosimilars. DSC arranges and ensures the product needed for Amgen’s clinical trials is available globally. DSC serve patients around the globe and ensure investigational product is at the clinics for the patients to receive their dose on time.The Global Study Planning (GSP) team, within DSC, is responsible for forecasting & planning the inventory in centralized warehouse and local hospitals. The planners apply Demand management and Supply Planning processes and assumptions in a regulated environment to ensure product supply to patients.The Global Study Planner (GSP) manager is pivotal role and supports all aspects of Demand and Supply Planning processes. The GSP manager ensures Finished Drug Product (FDP) supplies from study start throughout last patient dosed and has ownership of the planning aspects throughout the durations of the clinical studies and programs assigned until study closure. The GSP manager is responsible to ensure supply and to monitor inventory at all central locations and hospitals per study plans whilst minimizing product waste and optimizing and improving reliability, responsiveness, and stability of supply.In addition, the successful candidate will manage continuous improvement projects to advance Demand and Supply Planning methodologies in alignment with the department’s goals and aspirations under minimal direction. The successful candidate will lead projects and collaborate with cross functional teams and influence other functions and departments to ensure appropriate prioritization of Demand and Supply planning.
Translate Clinical Development product requirements of complex studies into an executable global supply plan, and ensure planning systems and tools are updated to reflect the product requirements as applicable
Apply systems autonomously to effectively manage products such as the Forecasting system/tool, SAP, Hospital inventory and dosing system, Dashboard controls and internal documents as a source for daily activities
Effectively manage product considering enrollment projections, the demand uncertainty, drug product availability, shelf life and scrap risk within management guidance
Proactively assess inventory positions (FDP) and implement plans to drive these to target volumes
Effectively communicate and lead forecasting and demand efforts, including key stakeholder meetings, to ensure the adequacy of supply/re-supply strategies and alignment
Actively participate in cross functional planning meetings to ensure that program/project priorities needs and timelines are met
Serve as the primary interface with Clinical Development, Quality, and Regulatory Affairs to ensure coordination of all activities necessary to maintain the forecast and ensure an adequate supply plan
Maintain inventory target levels as required at the depots and the clinics to ensure uninterrupted supply
Initiate production and stock transfers request on-time to meet labeling, packaging, and shipment of supplies. Indicate ratio, volume and timing of packaging and shipment of packed supplies
Identify risk to study timelines or clinical supplies, from a supply chain perspective, develop mitigation plans, and effectively communicate to all key partners and internal management
Monitors Key Performance Indicators (e.g., Safety, Quality, Delivery, Inventory, Productivity) to gauge performance make necessary adjustments. Identify root cause and corrective actions in case of deviations
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.Basic Qualifications:
Doctorate degree OR
Master’s degree and 2 years of supply chain experience OR
Bachelor’s degree and 4 years of supply chain experience OR
Associate’s degree and 8 years of supply chain experience OR
High school diploma / GED and 10 years of supply chain experience
Preferred Qualifications:
End to End Supply Chain planning experience and knowledge (preferable in clinical)
Highly proficient in Excel, Smartsheet, TEAMS, Tableau, and MS Office Suite
Experienced in SAP
Knowledge supporting Deviation, CAPA, CAPA-EV including initiating and owning deviations in Quality system
Experience working in a regulated environment, preferable pharmaceutical, GMP environment, and knowledge of regulatory guidelines impacting clinical supplies (i.e. GxP, GDP guidelines, GMP guidelines, ICH guidelines, Clinical Trial Directive)
Ability to analyze data and to communicate findings, knowledge share and make recommendations
Strong communication skills with the ability to communicate in multi-cultural global forums at network level
Master’s Degree or APICS certification
Working knowledge of regulatory and pharmaceutical processes
Ability to conduct effective root cause analysis
Works effectively in teams, self-starter, independent worker who takes on ownership, drives tasks / projects to completion
Readily adapts to, embraces and manages change
Develop and present scenario analyses to support decision making. Articulate clinical supply chain management processes and strategies
Anticipates, prevents, and resolve potential problems by independently developing solutions that are thorough, practical and consistent
Handles diverse scope of potential problems that may arise, that require evaluation of a variety of factors (demand forecast, product constraints, expiry management, transition plans, deviations, supply and shipment constraints)
Support the Supply Chain business process by finding opportunities and proposing potential solutions that will provide automation, advanced analytics, and insights to support strategic decision making
Identify scrap risks and take preventive actions to minimize scrap. Manage product transitions
Own and manage minor deviations and CAPAs
Review and update Standard Operations Procedures (SOP) and ensure SOP compliance. Identifies when controlled documents (e.g., TRNQs, GDEs, SOPs) need to be revised to align with regulatory requirements or to clarify work processes
Manages quality documents and records according to GxPs, SOPs, and ALCOA+ (Attributable, Legible, Contemporaneous, Original, and Accurate) principles in a timely manner
Prepare and communicate regular updates to key collaborators including senior management; able to adjust communication based on audience
Serves as a subject matter expert on operational processes and systems within their area of expertise
Follows GxPs (Good Practices) and SOPs (Standard Operating Procedures) when performing tasks
Supports preparing for Audits - Internal, partner and regulatory audits
What you can expect from usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.Application deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.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, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. 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 reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.