Project Manager Clinical Supply Chain

The Project Manager, Clinical Supply Chain is responsible for leading the global design and set up of end to end customized clinical supply chains in support of the assigned clinical programs/studies in a timely, efficient, effective and independent manner. This role is also responsible for partnering with several cross functional stakeholders such as early development, global development organization, global regulatory and product development teams, device engineering, clinical artwork team and clinical demand and inventory planning team. In addition, the Project Manager, Clinical Supply Chain will ensure supply for global clinical trial to support first subject enrolled plus provide robust inventory management tools for the clinical demand and inventory planning team

Tasks assigned to this role will include:

• Develop and employ project management techniques to design and set up supply chains for clinical studies.
• Create and maintain project plan to ensure timely clinical study start to support first subject enrolled
• Create and maintain study forecast for finished drug product (both Amgen and non-Amgen) in applicable systems to support clinical study start
• Design optimal packaging configuration for finished drug product taking into account protocol requirements and product characteristics.
• Ensure storage and shipping capabilities plus sufficient capacity for finished drug product is available within Amgen supply chain network (both internal and external) to support global study footprint.
• Design cost efficient (re)supply model to distribute finished drug product by taken into account risk analysis and mitigation strategy.
• Ensure efficient and smooth hand-over to clinical demand and inventory planning team
• Facilitate the phase in phase out strategy for new medicinal product introduction, such as running scenario's, impact on study demand and set up activities for formulation and device introductions
• Performs other functions as assigned

Basic Qualifications:

Doctorate degree

OR

Master's degree and 2 years of logistics, business administration or life science experience

OR

Bachelor's degree and 4 years of logistics, business administration or life science experience

OR

Associate's degree and 10 years of logistics, business administration or life science experience

OR

High school diploma / GED and 12 years of logistics, business administration or life science experience

Preferred Qualifications:

• Knowledge of clinical supply chain management
• Bachelor degree or equivalent in logistics, business administration or life science.
• 5 year's relevant working experience, preferably in the biotechnology or pharmaceutical industry, with an in-depth knowledge of supply chain management and clinical research management principles.
• At minimum 5 year experience in project leadership and project management techniques in an international and regulated environment
• General understanding of regulatory guidelines impacting clinical supplies (i.e. GxP, ICH guidelines, Clinical Trial Directive)
• Fluency in English, both verbal and written communication
• Advanced experience in MS Office applications
• Experience in using ERP systems, preferably SAP
• Project Management certification (PMP, IPMA)

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.