27 days old

Global Study Planner

Amgen
Thousand Oaks, CA 91360
  • Job Code
    115545360
Amgen

Job ID: R-87782
Location: Thousand Oaks, CA, US 91360

The Development Supply Chain (DSC) organization serves the needs of development functions from early to late stage, and delivers clinical product on time across the globe, concurrently generating critical manufacturing scale process and product data. The mission of the DSC organization is to deliver efficient end-to-end supply chain for product and data flows; leverage a controlled development environment for scale up, characterization and technology testing and implementation; and to provide a development service to enable the development continuum for material supply, development experimentation, and technology advancement.

As a member of the Development Supply Chain, the Global Study Planner is responsible for planning and executing delivery of clinical drug to clinical trial sites globally in support of Amgen's clinical trials across a variety of programs and program phases.

Key responsibilities:

• Translate Clinical Development requirements into an actionable supply plan
• Strategize with study managers and review study protocols to determine appropriate packaging configurations, blinding techniques, and optimal distribution plans
• Lead forecasting efforts, including key stakeholder meetings, to ensure the adequacy of supply/re-supply strategies and negotiate resolution of resource conflicts where necessary and actively participate in planning meetings to ensure that project needs, priorities, and timing are understood
• Serve as the primary interface with Clinical Development, Quality, Biostatistics, Regulatory Affairs, Corporate Planning, and Operations to ensure coordination of all activities necessary to develop the forecast and ensure an adequate supply plan
• Resolve logistical conflicts impacting studies and R&D milestones ensuring that supplies are not on the critical path and assess issues with regards to study design, supply availability, and timelines
• Provide input to matrix teams on timing, resourcing, and budget projections and determine distribution strategies for global studies
• Coordinate labeling, packaging, and shipment of packed supplies
• 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/project activities
• Oversee identification, appropriate provision and presentation of comparator agents to meet study requirements
• Articulate clinical supply chain management processes and strategies to key stakeholders
• Review and update existing procedures and SOPs; identify the need for and assist in the establishment of new procedures and SOPs

Basic Qualifications

Master's degree

OR

Bachelor's degree and 2 years of Supply Chain experience

OR

Associate's degree and 6 years of Supply Chain experience

OR

High school diploma / GED and 8 years of Supply Chain experience

Preferred Qualifications
  • Advanced degree in Life Sciences, Engineering or Business
  • 5+ years of work experience in the planning, manufacturing and global distribution of medicinal products
  • 3+ years organizational or program management (leading teams, cross-functional problem solving, performance management, budget oversight, process development and improvement)
  • 3+ years of work experience in clinical study design, approval, supply and management
  • 3+ years of supply chain management using SAP (logistics, supply planning, demand management)
  • APICS CPIM/CIRM certification


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.

PI115545360

<b>Amgen</b><br/><br/><b>Job ID: </b>R-87782<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Development Supply Chain (DSC) organization serves the needs of development functions from early to late stage, and delivers clinical product on time across the globe, concurrently generating critical manufacturing scale process and product data. The mission of the DSC organization is to deliver efficient end-to-end supply chain for product and data flows; leverage a controlled development environment for scale up, characterization and technology testing and implementation; and to provide a development service to enable the development continuum for material supply, development experimentation, and technology advancement.<br><br>As a member of the Development Supply Chain, the Global Study Planner is responsible for planning and executing delivery of clinical drug to clinical trial sites globally in support of Amgen's clinical trials across a variety of programs and program phases.<br><br>Key responsibilities:<br><br> Translate Clinical Development requirements into an actionable supply plan<br> Strategize with study managers and review study protocols to determine appropriate packaging configurations, blinding techniques, and optimal distribution plans<br> Lead forecasting efforts, including key stakeholder meetings, to ensure the adequacy of supply/re-supply strategies and negotiate resolution of resource conflicts where necessary and actively participate in planning meetings to ensure that project needs, priorities, and timing are understood<br> Serve as the primary interface with Clinical Development, Quality, Biostatistics, Regulatory Affairs, Corporate Planning, and Operations to ensure coordination of all activities necessary to develop the forecast and ensure an adequate supply plan<br> Resolve logistical conflicts impacting studies and R&D milestones ensuring that supplies are not on the critical path and assess issues with regards to study design, supply availability, and timelines<br> Provide input to matrix teams on timing, resourcing, and budget projections and determine distribution strategies for global studies<br> Coordinate labeling, packaging, and shipment of packed supplies<br> Promptly identify and escalate risks to study timelines or clinical supplies, from a supply chain perspective, to all key stakeholders and internal management<br> Utilize systems to effectively manage key product/project activities<br> Oversee identification, appropriate provision and presentation of comparator agents to meet study requirements<br> Articulate clinical supply chain management processes and strategies to key stakeholders<br> Review and update existing procedures and SOPs; identify the need for and assist in the establishment of new procedures and SOPs<br><br><b>Basic Qualifications </b><br><br>Master's degree <br><br> OR <br><br> Bachelor's degree and 2 years of Supply Chain experience <br><br> OR <br><br> Associate's degree and 6 years of Supply Chain experience <br><br> OR <br><br> High school diploma / GED and 8 years of Supply Chain experience <br><br><b>Preferred Qualifications </b><br><ul><li>Advanced degree in Life Sciences, Engineering or Business</li><li>5+ years of work experience in the planning, manufacturing and global distribution of medicinal products</li><li>3+ years organizational or program management (leading teams, cross-functional problem solving, performance management, budget oversight, process development and improvement)</li><li>3+ years of work experience in clinical study design, approval, supply and management</li><li>3+ years of supply chain management using SAP (logistics, supply planning, demand management)</li><li>APICS CPIM/CIRM certification</li></ul><br><br>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.<br><br>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.<br><br><b> 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. </b><br><br>Join Us <br> <br> 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. <br> <br> 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. <br> <br> 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. <br> <br> 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.<br/><br/> <img src="https://analytics.click2apply.net/v/m6rq8YhbDNVpfKlqs4m2Z"> <p>PI115545360</p>

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Posted: 2019-11-16 Expires: 2019-12-17

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Global Study Planner

Amgen
Thousand Oaks, CA 91360

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