AstraZeneca
Cell Therapy Engagement Manager
AstraZeneca, Wilmington, Delaware, us, 19894
At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most sophisticated diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.
Position Summary:
The Cell Therapy Site Engagement Manager (CTEM) is a dynamic role, responsible to develop and foster relationships with AstraZeneca (AZ) clinical sites and cell therapy site personnel for assigned region(s). This person will serve as a single point-of-contact providing outstanding customer service for AZ’s cell therapy site network while providing knowledge and expertise around products and processes to all customer partners. Responsible for developing product-specific processes and procedures to onboard and handle the AZ site network used for cell therapy products. This role will provide support for the vein-to-vein process from patient registration, apheresis collection (starting material) and product infusion while supervising ongoing account performance post-site activation. This will be a remote position with a strong emphasis on relationship building including in-person and on-site support for assigned territory. Sixty percent of travel may be required within the United States and/or EX-US regions.
Responsibilities:
Develop and foster relationships with clinical sites and cell therapy site personnel for assigned region(s)
Work in close partnership with the cross-functional AZ Cell Therapy Team to engage and qualify key treatment centers with both clinical trial and commercial intent
Provide on-site apheresis collection and IMP administration support.
Collect VOC (voice-of-customer) and VOB (voice-of-business) feedback used for continuous operations improvement
Provide input to the development of the cell journey with regards to apheresis and cell therapy-specific processes
Coordinate with cell therapy site staff to ensure all apheresis and IMP receipt/storage/administration onboarding activities completed and sites are prepared to treat patients for clinical trials and or in authorized treatment centers
Work with AZ business partners to supervise metrics, assess performance and recommend commercial capabilities
Ensure that issues related to cellular starting material are appropriately evaluated, investigated, and provide feedback and follow-up with the treatment centers providing the apheresis material
Develop internal and external-facing training materials for AZ teams and sites
Deliver and support the coordination of site trainings on AZ’s Apheresis and IMP handling manual in collaboration with Supply Chain
Support qualification and ongoing training of treatment centers on-site to ensure they can carry out to the AZ requirements to treat patients with AZs cell therapy products in both the clinical and commercial setting
Author and maintain Apheresis Handling manuals, Investigational Medicinal Product (IMP) Handling manuals and forms that are product-specific to support all active trials in collaboration with cross functional teams
On-site meetings to support and drive negotiation and maintenance of contracts, including the Apheresis Agreements and Quality Agreement in coordination with legal teams and Apheresis QA
Ensure high quality and consistent provision of apheresis collection through assessment and monitoring of clinical sites
Conduct investigations in case of deviations on starting material and oversight of the end-to-end process deviations in close coordination with all relevant functions
Maintain and evaluate key performance indicators for site performance and internal metrics
Lead rollout of process changes to assigned sites and train sites on changes
Triage and escalate communications from Investigator Sites and AZ internal departments as needed
Identify and initiate deviations as applicable, with partner concern to appropriate departments as required
Education & Experience Requirements:
BS with 5+ years, or MS with 3+ years of relevant shown experience
3+ years of proven experience within a Cell Therapy Operations unit in the pharmaceutical or biotechnology industry, healthcare systems and/or regulatory environment
Required Skills:
Ability to rapidly address problems, ready to take decisions and deal with organizational complexity
Ability to prioritize and complete work with sense of urgency based on criticality
Knowledge of applicable regulations and standards (US, APAC, and UK/EU)
Experience in Customer Service Role
Experience in a regulated environment either hospital or pharmaceutical/biotech
Highly effective in working in a global environment, to accommodate different time zone as needed.
Excellent command of MS PowerPoint, Word, Excel, and Project
Excellent verbal, and written communication skills
Desired Skills:
Advanced degree in the Life Sciences or Engineering (e.g., Pharm D, NP, PA, Biomedical Engineer)
Experience working in Apheresis, Cellular Therapy or Stem Cell Transplant programs.
Prior customer facing role in pharmaceutical/biotech industry
Experience working with critical raw material suppliers or contract manufacturing organizations
Proficient in other languages a plus
Ready to make a difference? Apply today and join us in our mission to create life-changing medicines!
#J-18808-Ljbffr
Position Summary:
The Cell Therapy Site Engagement Manager (CTEM) is a dynamic role, responsible to develop and foster relationships with AstraZeneca (AZ) clinical sites and cell therapy site personnel for assigned region(s). This person will serve as a single point-of-contact providing outstanding customer service for AZ’s cell therapy site network while providing knowledge and expertise around products and processes to all customer partners. Responsible for developing product-specific processes and procedures to onboard and handle the AZ site network used for cell therapy products. This role will provide support for the vein-to-vein process from patient registration, apheresis collection (starting material) and product infusion while supervising ongoing account performance post-site activation. This will be a remote position with a strong emphasis on relationship building including in-person and on-site support for assigned territory. Sixty percent of travel may be required within the United States and/or EX-US regions.
Responsibilities:
Develop and foster relationships with clinical sites and cell therapy site personnel for assigned region(s)
Work in close partnership with the cross-functional AZ Cell Therapy Team to engage and qualify key treatment centers with both clinical trial and commercial intent
Provide on-site apheresis collection and IMP administration support.
Collect VOC (voice-of-customer) and VOB (voice-of-business) feedback used for continuous operations improvement
Provide input to the development of the cell journey with regards to apheresis and cell therapy-specific processes
Coordinate with cell therapy site staff to ensure all apheresis and IMP receipt/storage/administration onboarding activities completed and sites are prepared to treat patients for clinical trials and or in authorized treatment centers
Work with AZ business partners to supervise metrics, assess performance and recommend commercial capabilities
Ensure that issues related to cellular starting material are appropriately evaluated, investigated, and provide feedback and follow-up with the treatment centers providing the apheresis material
Develop internal and external-facing training materials for AZ teams and sites
Deliver and support the coordination of site trainings on AZ’s Apheresis and IMP handling manual in collaboration with Supply Chain
Support qualification and ongoing training of treatment centers on-site to ensure they can carry out to the AZ requirements to treat patients with AZs cell therapy products in both the clinical and commercial setting
Author and maintain Apheresis Handling manuals, Investigational Medicinal Product (IMP) Handling manuals and forms that are product-specific to support all active trials in collaboration with cross functional teams
On-site meetings to support and drive negotiation and maintenance of contracts, including the Apheresis Agreements and Quality Agreement in coordination with legal teams and Apheresis QA
Ensure high quality and consistent provision of apheresis collection through assessment and monitoring of clinical sites
Conduct investigations in case of deviations on starting material and oversight of the end-to-end process deviations in close coordination with all relevant functions
Maintain and evaluate key performance indicators for site performance and internal metrics
Lead rollout of process changes to assigned sites and train sites on changes
Triage and escalate communications from Investigator Sites and AZ internal departments as needed
Identify and initiate deviations as applicable, with partner concern to appropriate departments as required
Education & Experience Requirements:
BS with 5+ years, or MS with 3+ years of relevant shown experience
3+ years of proven experience within a Cell Therapy Operations unit in the pharmaceutical or biotechnology industry, healthcare systems and/or regulatory environment
Required Skills:
Ability to rapidly address problems, ready to take decisions and deal with organizational complexity
Ability to prioritize and complete work with sense of urgency based on criticality
Knowledge of applicable regulations and standards (US, APAC, and UK/EU)
Experience in Customer Service Role
Experience in a regulated environment either hospital or pharmaceutical/biotech
Highly effective in working in a global environment, to accommodate different time zone as needed.
Excellent command of MS PowerPoint, Word, Excel, and Project
Excellent verbal, and written communication skills
Desired Skills:
Advanced degree in the Life Sciences or Engineering (e.g., Pharm D, NP, PA, Biomedical Engineer)
Experience working in Apheresis, Cellular Therapy or Stem Cell Transplant programs.
Prior customer facing role in pharmaceutical/biotech industry
Experience working with critical raw material suppliers or contract manufacturing organizations
Proficient in other languages a plus
Ready to make a difference? Apply today and join us in our mission to create life-changing medicines!
#J-18808-Ljbffr