Global Medical Affairs, Clinical Supply Manager
DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden.
For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and have helped physicians enhance patient care with our broad product portfolio.
Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease.
Lantheus is in search of an innovative, transformative, high-energy, experienced professional to lead the SAP Finance IT Team.
Our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success.
Every employee is crucial to our success, we respect one another and act as one knowing that someone's health is in our hands.
We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skills sets to be a part of a productive and inclusive team.
The Global Medical Affairs (GMA), Clinical Supply Manager is responsible for supporting multiple, global Lantheus Clinical Trials Programs including Investigator Sponsored Trials (IST), and Partnership trials.
Working closely with Clinical Supply Chain, Manufacturing, Pharma Services, Clinical Operations, and Regulatory Affairs to develop clinical supply chains for each product, to ensure that clinical supplies are available in an uninterrupted fashion for assigned studies, and to maintain study documentation in an audit-ready status.
Coordinating the scheduling, supply and timely delivery of radiopharmaceuticals to clinical study sites is a primary responsibility.
This position will also be responsible for department process improvement initiativesExcellent knowledge of the global clinical supply and clinical study processes, of cGMP and GCP regulations, ICH Guidelines as it relates to Good Distribution Practices (GDPs) and local country drug shipment regulations.
Ensures study management activities are aligned.
Develops and maintains effective interfaces with key customers (external and internal).
Fully understands the clinical study and clinical supply processes; viewed by peers as a leader with a high level of respectability and complete knowledge of processes and strategies.
Create, review and update the clinical supply and demand plans based on strategic elements/study forecasts from Clinical Operations for studies and/or programs.
Participate in cross-functional Project Team Meetings.
Ensure changes in supply configuration, trial design, enrollment timelines, manufacturing availability and regulatory requirements are considered.
Creates close collaborations to meet key milestones in the clinical supply process including decisions on clinical supply strategies and designs and approved documentation to support clinical supply production.
Maintains best practices associated with managing clinical supply chains.
Assist with the management of tracking activities for assigned studies across all marketed and investigational products in accordance with SOPs.
Makes recommendations for upgrades to program and project content, process, and timelines.
Ensures accurate reporting on progress, milestone achievement and issues to upper management.
Recognizes and escalates to appropriate personnel significant issues relating to compliance, timelines or other issues that jeopardize business objectives.
Demonstrates leadership skills by driving for continuous improvement and encouraging and supporting collaboration across departments.
Typical Minimum Skills and Experience and Education Bachelor's degree in Business, Supply Chain/Procurement, or science-related field of study; (equivalent work experience may be considered)Minimum of 5 years clinical supply chain management experience (North America and EU preferred)Excellent computer skills, including high proficiency with Microsoft Suite including Excel, Word, PowerPoint and MS Project as well as the Office 365 environmentExperience working with radiopharmaceuticals will be considered an asset but is not a requirement.
Other RequirementsHigh attention to detail, strong analytical and organizational skillsExcellent ability to multitask and prioritize workloadProven ability to successfully manage multiple tasks simultaneously and adapt to and communicate changeExceptional communicator with strong oral and written communications skillsExcellent planning skills with the ability to work seamlessly as part of a team or independently.
Experience in an FDA regulated environment a plusOperate and execute with an extreme sense of urgency Recommended Skills Analytical Attention To Detail Auditing Business Planning Business Process Improvement Clinical Works Estimated Salary: $20 to $28 per hour based on qualifications.
For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and have helped physicians enhance patient care with our broad product portfolio.
Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease.
Lantheus is in search of an innovative, transformative, high-energy, experienced professional to lead the SAP Finance IT Team.
Our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success.
Every employee is crucial to our success, we respect one another and act as one knowing that someone's health is in our hands.
We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skills sets to be a part of a productive and inclusive team.
The Global Medical Affairs (GMA), Clinical Supply Manager is responsible for supporting multiple, global Lantheus Clinical Trials Programs including Investigator Sponsored Trials (IST), and Partnership trials.
Working closely with Clinical Supply Chain, Manufacturing, Pharma Services, Clinical Operations, and Regulatory Affairs to develop clinical supply chains for each product, to ensure that clinical supplies are available in an uninterrupted fashion for assigned studies, and to maintain study documentation in an audit-ready status.
Coordinating the scheduling, supply and timely delivery of radiopharmaceuticals to clinical study sites is a primary responsibility.
This position will also be responsible for department process improvement initiativesExcellent knowledge of the global clinical supply and clinical study processes, of cGMP and GCP regulations, ICH Guidelines as it relates to Good Distribution Practices (GDPs) and local country drug shipment regulations.
Ensures study management activities are aligned.
Develops and maintains effective interfaces with key customers (external and internal).
Fully understands the clinical study and clinical supply processes; viewed by peers as a leader with a high level of respectability and complete knowledge of processes and strategies.
Create, review and update the clinical supply and demand plans based on strategic elements/study forecasts from Clinical Operations for studies and/or programs.
Participate in cross-functional Project Team Meetings.
Ensure changes in supply configuration, trial design, enrollment timelines, manufacturing availability and regulatory requirements are considered.
Creates close collaborations to meet key milestones in the clinical supply process including decisions on clinical supply strategies and designs and approved documentation to support clinical supply production.
Maintains best practices associated with managing clinical supply chains.
Assist with the management of tracking activities for assigned studies across all marketed and investigational products in accordance with SOPs.
Makes recommendations for upgrades to program and project content, process, and timelines.
Ensures accurate reporting on progress, milestone achievement and issues to upper management.
Recognizes and escalates to appropriate personnel significant issues relating to compliance, timelines or other issues that jeopardize business objectives.
Demonstrates leadership skills by driving for continuous improvement and encouraging and supporting collaboration across departments.
Typical Minimum Skills and Experience and Education Bachelor's degree in Business, Supply Chain/Procurement, or science-related field of study; (equivalent work experience may be considered)Minimum of 5 years clinical supply chain management experience (North America and EU preferred)Excellent computer skills, including high proficiency with Microsoft Suite including Excel, Word, PowerPoint and MS Project as well as the Office 365 environmentExperience working with radiopharmaceuticals will be considered an asset but is not a requirement.
Other RequirementsHigh attention to detail, strong analytical and organizational skillsExcellent ability to multitask and prioritize workloadProven ability to successfully manage multiple tasks simultaneously and adapt to and communicate changeExceptional communicator with strong oral and written communications skillsExcellent planning skills with the ability to work seamlessly as part of a team or independently.
Experience in an FDA regulated environment a plusOperate and execute with an extreme sense of urgency Recommended Skills Analytical Attention To Detail Auditing Business Planning Business Process Improvement Clinical Works Estimated Salary: $20 to $28 per hour based on qualifications.
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