Adverum Biotechnologies, Inc.
Manager of Clinical Supply Chain
Adverum Biotechnologies, Inc., Redwood City, California, United States, 94061
We are looking for a Manager of Clinical Supply Chain. This position reports to the Sr. Director of the Supply Chain. The Manager of Clinical Supply Chain will play a key role in managing, planning, coordination and execution of activities related to procurement, labeling and packaging, distribution, and shipping logistics for clinical supplies.
What you’ll do:
Develop KPIs and monitor vendor performance and address any issues or discrepancies promptly.Establish and maintain effective, transparent Supply Chain business processes.Ensure that GCP, regulatory and clinical protocol requirements are followed.Manage relationships with CMOs and key suppliers including coordination, communication, technical oversight and escalation to ensure timely delivery, shipment and distribution of drug products, comparators and other ancillary supplies to support global clinical trials.Perform study closeout activities including returned goods reconciliation and inventory destruction processing, as applicable.Develop and maintain detailed inventories of clinical materials at CMOs, sites and depots, perform monthly reconciliation to ensure there are adequate materials to meet trial requirements and address potential risk.Create and maintain accurate forecasts for clinical trials.Manage inventory of Adverum’s clinical trial materials to meet clinical trial requirements.Partner with Clinical Operations to define and update the study drug supply strategy, requirements, distribution warehouse, import/export requirements for clinical study in line with the study protocols.Responsible for coordinating and scheduling drug labeling and packaging activities in conjunction with CMC, clinical and regulatory departments.Review all relevant packaging batch records and executed manufacturing batch records to ensure alignment with pertinent regulatory documentation, e.g. IND, CTAs/IMPDs.Oversee vendor activities including comparator drug procurement, labeling performance, material release, on-time delivery, quality, improvement initiatives and issue resolution.Responsible for logistics as required to support the labeling, packaging and shipment of clinical trial material supplies to depots/investigative sites as well as other clinical trial material supplies necessary.Primary liaison for inventory control and distribution activities including scheduling, issue resolution, change implementation, expiry date management, vendor oversight and scope review related to clinical trial materials.Monitor and track shipments to depots/investigative sites to ensure smooth transit through the logistical path, including international shipping and reconciliation, returns and/or destruction of used and unused clinical trial materials.Develop label text for all Adverum clinical trial materials and coordinate label text language translations for Ex-US trials.Lead IRT building for study with particular focus on clinical supply aspects of IRT for Adverum clinical trials, including review of relevant documentation, completion of required User Acceptance Testing, release of study drug to clinical sites, and creation/adjustment of clinical supply strategies at depots and investigative sites.Identify and support the qualification of new suppliers/vendors in collaboration with other departments.Prepare and review service provider agreements and negotiate competitive pricing.Anticipate supply chain interruptions based on industry trends and prepare contingency plans for safety stock as appropriate.Generate and review processes as required and ensure compliance with relevant SOPs, regulations and laws.Facilitate regular meetings with cross-functional teams to ensure alignment and coordination of clinical supply activities.Lead clinical trial material supply process improvement efforts, developing and monitoring Key Performance Indicators.Prepare and adhere to supply chain Standard Operating Procedures and work instructions.Develop drug supply training materials for investigational sites.Support development and maintenance of pharmacy manuals for all Adverum clinical trials in conjunction with relevant cross-functional leads.Implement Industry Best Practices and templates for clinical trial material supply activities.About you:
A minimum of bachelor’s degree is required, an advanced degree is preferred.A minimum of 6-10 years of work experience in the pharmaceutical industry of which at least three (3) years in a supply chain related role. Experience with biologics and cold chain products is a must.Demonstrated ability to learn software applications related to Supply Chain and proficiency in Microsoft Office Suite.Demonstrated experience in developing and managing forecasts for clinical or commercial supply chains.International/global experience preferred.Deep understanding of regulatory, GDPR, data privacy, HIPA and import/export requirements.Solid understanding of current GMP/GCP requirements and other relevant pharmaceutical industry procedures and regulations.Experience with IRT systems (IVR/IWR) is a must.Demonstrated ability to work independently and to influence and negotiate with cross-functional teams at various levels within the organization.Ability to create and deliver business cases and updates to Senior Leadership.Ability to adapt effectively to rapidly changing organization structures and dynamics, clinical study design changes and regulation changes.Demonstrated ability to work with third-party vendors and service providers.Must be comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.Highly organized and detail-oriented.Strong analytical and problem-solving skills.
$120,000 - $140,000 a year
The salary range for this position is $120,000 USD to $140,000 USD annually, with the opportunity to earn an annual bonus. This salary range is an estimate, and the actual salary may vary based on a candidate’s qualifications, including education, length of experience, location, and market data. Employees in this position are eligible to participate in the applicable Company equity incentive award plan. The amount of incentive varies and is subject to the terms and conditions of the plan. Employees in this position are eligible to participate in the Company’s standard employee benefit programs, which currently include the following: medical, dental, vision, 401k, STD/LTD, life and accident insurance, and either paid time off or flexible paid time off.About UsAdverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.At Adverum,
Inclusion
and
Diversity
are at our core. We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum
Community
to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation.
#J-18808-Ljbffr
What you’ll do:
Develop KPIs and monitor vendor performance and address any issues or discrepancies promptly.Establish and maintain effective, transparent Supply Chain business processes.Ensure that GCP, regulatory and clinical protocol requirements are followed.Manage relationships with CMOs and key suppliers including coordination, communication, technical oversight and escalation to ensure timely delivery, shipment and distribution of drug products, comparators and other ancillary supplies to support global clinical trials.Perform study closeout activities including returned goods reconciliation and inventory destruction processing, as applicable.Develop and maintain detailed inventories of clinical materials at CMOs, sites and depots, perform monthly reconciliation to ensure there are adequate materials to meet trial requirements and address potential risk.Create and maintain accurate forecasts for clinical trials.Manage inventory of Adverum’s clinical trial materials to meet clinical trial requirements.Partner with Clinical Operations to define and update the study drug supply strategy, requirements, distribution warehouse, import/export requirements for clinical study in line with the study protocols.Responsible for coordinating and scheduling drug labeling and packaging activities in conjunction with CMC, clinical and regulatory departments.Review all relevant packaging batch records and executed manufacturing batch records to ensure alignment with pertinent regulatory documentation, e.g. IND, CTAs/IMPDs.Oversee vendor activities including comparator drug procurement, labeling performance, material release, on-time delivery, quality, improvement initiatives and issue resolution.Responsible for logistics as required to support the labeling, packaging and shipment of clinical trial material supplies to depots/investigative sites as well as other clinical trial material supplies necessary.Primary liaison for inventory control and distribution activities including scheduling, issue resolution, change implementation, expiry date management, vendor oversight and scope review related to clinical trial materials.Monitor and track shipments to depots/investigative sites to ensure smooth transit through the logistical path, including international shipping and reconciliation, returns and/or destruction of used and unused clinical trial materials.Develop label text for all Adverum clinical trial materials and coordinate label text language translations for Ex-US trials.Lead IRT building for study with particular focus on clinical supply aspects of IRT for Adverum clinical trials, including review of relevant documentation, completion of required User Acceptance Testing, release of study drug to clinical sites, and creation/adjustment of clinical supply strategies at depots and investigative sites.Identify and support the qualification of new suppliers/vendors in collaboration with other departments.Prepare and review service provider agreements and negotiate competitive pricing.Anticipate supply chain interruptions based on industry trends and prepare contingency plans for safety stock as appropriate.Generate and review processes as required and ensure compliance with relevant SOPs, regulations and laws.Facilitate regular meetings with cross-functional teams to ensure alignment and coordination of clinical supply activities.Lead clinical trial material supply process improvement efforts, developing and monitoring Key Performance Indicators.Prepare and adhere to supply chain Standard Operating Procedures and work instructions.Develop drug supply training materials for investigational sites.Support development and maintenance of pharmacy manuals for all Adverum clinical trials in conjunction with relevant cross-functional leads.Implement Industry Best Practices and templates for clinical trial material supply activities.About you:
A minimum of bachelor’s degree is required, an advanced degree is preferred.A minimum of 6-10 years of work experience in the pharmaceutical industry of which at least three (3) years in a supply chain related role. Experience with biologics and cold chain products is a must.Demonstrated ability to learn software applications related to Supply Chain and proficiency in Microsoft Office Suite.Demonstrated experience in developing and managing forecasts for clinical or commercial supply chains.International/global experience preferred.Deep understanding of regulatory, GDPR, data privacy, HIPA and import/export requirements.Solid understanding of current GMP/GCP requirements and other relevant pharmaceutical industry procedures and regulations.Experience with IRT systems (IVR/IWR) is a must.Demonstrated ability to work independently and to influence and negotiate with cross-functional teams at various levels within the organization.Ability to create and deliver business cases and updates to Senior Leadership.Ability to adapt effectively to rapidly changing organization structures and dynamics, clinical study design changes and regulation changes.Demonstrated ability to work with third-party vendors and service providers.Must be comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.Highly organized and detail-oriented.Strong analytical and problem-solving skills.
$120,000 - $140,000 a year
The salary range for this position is $120,000 USD to $140,000 USD annually, with the opportunity to earn an annual bonus. This salary range is an estimate, and the actual salary may vary based on a candidate’s qualifications, including education, length of experience, location, and market data. Employees in this position are eligible to participate in the applicable Company equity incentive award plan. The amount of incentive varies and is subject to the terms and conditions of the plan. Employees in this position are eligible to participate in the Company’s standard employee benefit programs, which currently include the following: medical, dental, vision, 401k, STD/LTD, life and accident insurance, and either paid time off or flexible paid time off.About UsAdverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.At Adverum,
Inclusion
and
Diversity
are at our core. We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum
Community
to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation.
#J-18808-Ljbffr