Manager, Clinical Supply Management San Diego, California, United States; Verona
Arrowhead Pharmaceuticals, Inc, San Diego, CA, United States
Overview
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
This function is responsible for coordination of investigational medicinal product (IMP) and ancillary supply planning, forecasting, labeling, packaging, distribution, inventory monitoring, and reconciliation for Arrowhead Pharmaceuticals clinical development programs.
This role is based in onsite with an expectation to be in the office five days a week.
Responsibilities
Collaborate cross-functionally with Clinical Development, Manufacturing, Regulatory Affairs, and Quality Assurance to plan and execute IMP supply planning including labeling and packaging, utilization forecasting, inventory control, and international shipments and external depot management for Phase 1-4 international clinical studies
Develop clinical supplies distribution plans based on program and study timelines, trial design, recruitment, geography, and manufacturing schedules
Coordinate and manage clinical supplies forecasting and utilization to ensure on-time and reliable availability of IMP and required ancillary supplies in support of study execution
Serve as the primary point of contact cross-functionally for clinical supplies planning, inventory monitoring, and distribution, and third-party service provider/depot selection and oversight
Coordinate with Manufacturing Operations, Quality Assurance and Regulatory Affairs to ensure planned IMP release testing/re-testing, stability, expiry dates, labeling and packaging schedules align with program milestones, adjusting as necessary over the course of the program
Develop and manage SOPs, work instructions, processes, systems, and forms governing clinical supplies management in alignment with industry standards and regulatory requirements
Serve as internal subject matter expert on fit-for-purpose labeling and packaging design options best suited to meet study requirements
Serve as liaison between Clinical Operations and Quality Assurance to manage IMP stability parameters, temperature deviation management, product complaints and associated investigations
Requirements
Experience with electronic interactive response technologies for inventory management
Experience with managing supply for clinical investigations of injectables and biologics
Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner
Thorough understanding of GMP, GCP, and ICH standards governing IMP labeling, packaging, and distribution
Proficient in MS Officer (Word, Excel, and PowerPoint)
Ability to work in a team or independently
Effective interpersonal, written, and verbal communication skills
Able to critically evaluate and prioritize job tasks and the impact on overall study execution
Strong problem-solving capabilities
Effectively collaborates with Study Team members
Exceptional organizational skills with the ability to multi-task and prioritize
Ability to work with distributed team members and outside vendors
Preferred
Experience in multiple therapeutic areas
$120,000 — $140,000 USD
$135,000 — $155,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
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Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
This function is responsible for coordination of investigational medicinal product (IMP) and ancillary supply planning, forecasting, labeling, packaging, distribution, inventory monitoring, and reconciliation for Arrowhead Pharmaceuticals clinical development programs.
This role is based in onsite with an expectation to be in the office five days a week.
Responsibilities
Collaborate cross-functionally with Clinical Development, Manufacturing, Regulatory Affairs, and Quality Assurance to plan and execute IMP supply planning including labeling and packaging, utilization forecasting, inventory control, and international shipments and external depot management for Phase 1-4 international clinical studies
Develop clinical supplies distribution plans based on program and study timelines, trial design, recruitment, geography, and manufacturing schedules
Coordinate and manage clinical supplies forecasting and utilization to ensure on-time and reliable availability of IMP and required ancillary supplies in support of study execution
Serve as the primary point of contact cross-functionally for clinical supplies planning, inventory monitoring, and distribution, and third-party service provider/depot selection and oversight
Coordinate with Manufacturing Operations, Quality Assurance and Regulatory Affairs to ensure planned IMP release testing/re-testing, stability, expiry dates, labeling and packaging schedules align with program milestones, adjusting as necessary over the course of the program
Develop and manage SOPs, work instructions, processes, systems, and forms governing clinical supplies management in alignment with industry standards and regulatory requirements
Serve as internal subject matter expert on fit-for-purpose labeling and packaging design options best suited to meet study requirements
Serve as liaison between Clinical Operations and Quality Assurance to manage IMP stability parameters, temperature deviation management, product complaints and associated investigations
Requirements
Experience with electronic interactive response technologies for inventory management
Experience with managing supply for clinical investigations of injectables and biologics
Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner
Thorough understanding of GMP, GCP, and ICH standards governing IMP labeling, packaging, and distribution
Proficient in MS Officer (Word, Excel, and PowerPoint)
Ability to work in a team or independently
Effective interpersonal, written, and verbal communication skills
Able to critically evaluate and prioritize job tasks and the impact on overall study execution
Strong problem-solving capabilities
Effectively collaborates with Study Team members
Exceptional organizational skills with the ability to multi-task and prioritize
Ability to work with distributed team members and outside vendors
Preferred
Experience in multiple therapeutic areas
$120,000 — $140,000 USD
$135,000 — $155,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
#J-18808-Ljbffr