Senior Manager, Clinical Supply Management

Arrowhead Pharmaceuticals; Madison (WI); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Benefits package

Job summary

Arrowhead Pharmaceuticals, Inc. in Madison, WI is seeking a dedicated Clinical Supply Chain Manager to plan and manage IMP supply, labeling, packaging, inventory, and distribution for multiple studies.

You will coordinate with global CMOs and cross-functional teams to ensure on-time delivery, cost efficiency, and high quality, while driving process improvements and governance. This role is onsite, five days a week.

Qualifications

• Thorough understanding of GMP, GCP, and ICH standards governing IMP labeling, packaging, and global distribution.
• Proficient with MS Office and Smartsheet; ability to work independently.
• Excellent communication and teamwork skills for cross-functional collaboration.
• Able to manage multiple tasks with strong prioritization and problem-solving.

Responsibilities

• Forecast, plan, and execute IMP supply plans including labeling, packaging, inventory, and depot management.
• Update distribution plans based on timelines, design, changes, recruitment, geography, and schedules.
• Develop plans for ancillary supply sourcing and ensure compatibility with IMP.
• Create, maintain SOPs and forms for clinical supplies management.
• Manage IMP shelf-life extensions and deviation investigations with QA.
• Identify potential supply chain vendors and review proposals.
• Oversee the global network of CMOs and packaging activities.
• Collaborate to determine manufacturing requirements and enable on-time delivery.
• Lead procurement-related activities for RFQs/SOWs and negotiate supply agreements.
• Support QA in establishing QA agreements with CMOs and PSR requirements.
• Drive process improvements and cross-functional problem solving.
• Ensure proper communication with stakeholders regarding timelines.

Skills

GMP/GCP/ICH knowledge

MS Office

Smartsheet

Cross-functional collaboration

Tools

MS Office

Smartsheet

Job description

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial 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. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. 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 that are 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 role is responsible for the planning and management of investigational medicinal product (IMP) needed to ensure uninterrupted patient dosing for assigned clinical studies. This role will create and maintain study forecast and supply plans, develop clinical labels, execute packaging and labeling activities, manage distribution, inventory, and returns & reconciliation of clinical studies.

Furthermore, this role will be required to work closely with clinical contract manufacturers (CMOs) worldwide, as well as other cross functional partners to ensure supply continuity with optimal cost and quality. You will drive the evolution and implementation of new platforms, systems and processes that enable greater operational efficiency, accuracy, and utilization of the product portfolio. You will use your manufacturing and PM experience as well as partner relationships to optimize the overall supply chain helping to achieve the goal of delivering Arrowhead’s pipeline to patients.

This role is based in onsite with an expectation to be in the office five days a week.

Responsibilities

• Collaborate cross-functionally with Clinical Operations, Manufacturing, Regulatory Affairs, and Quality Assurance to forecast, plan, and execute IMP supply plans including IMP utilization, labeling and packaging, inventory control, and depot management for assigned clinical studies.
• Develop, update, and adapt clinical supplies distribution plans based on program and study timelines, trial design, clinical program changes, recruitment, geography, and manufacturing schedules.
• Develop plans for ancillary supply sourcing and liaise with CMC team to ensure ancillary compatibility with IMP.
• Develop and manage SOPs, work instructions, processes, systems, and forms governing clinical supplies management in alignment with industry standards and regulatory requirements.
• Work with cross functional team including Clinical Operations and Quality Assurance to manage IMP shelf-life extensions, temperature deviation management, product complaints, and associated investigations.
• Identify potential supply chain vendors and review proposals contributing to the selection process.
• Oversee aspects of Arrowhead’s global network of clinical CMOs supporting clinical drug supply. Scope of work includes management of drug from the release of Drug Product (DP) at the filling site through release of Final Packaged Goods (FG) at the label/pack site (or depot in some cases); scheduling and oversight of label/pack execution activities at the label/pack site; and ensuring the necessary materials and components are available for execution.
• Collaborate with internal cross-functional teams to determine manufacturing requirements. Drive contract manufacturer capability and capacity to enable on-time and predictable delivery of packaged clinical product.
• Manage the operational pack activities (schedule, timelines, etc.) of the CMO ensuring program cost, quality, metrics, delivery, and technology objectives are met as well as manage the partner performance to achieve them. Proactively intercede if goals and timelines are jeopardized, communicating to appropriate stakeholders as needed.
• Partner with key stakeholders in the preparation for Requests for Quotes (RFQs), Statements of Work (SOW) and negotiate supply agreements for clinical programs.
• Serve as the manufacturing outsourcing team leader on cross-functional teams as requested in support of clinical finished good packaging.
• Support QA in establishing QA agreements with all CMO’s and assuring that Product Specific Requirements (PSR’s) are established before projects are initiated.
• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.
• Identify and champion process improvement solutions to complex issues with inter-organizational impact.

Requirements

• Thorough understanding of GMP, GCP, and ICH standards governing IMP labeling,
• packaging, and global distribution.
• Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner.
• Proficient in MS Office (Word, Excel, and PowerPoint) and Smartsheet
• 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 cross-functional team members.
• Exceptional organizational skills with the ability to multi-task and prioritize.

Preferred

• Minimum of 6-8 years in a clinical supply chain management and/or PM role; additional industry experience desired.
• Experience with electronic interactive response technologies for inventory management

Arrowhead provides competitive salaries and an excellent benefit package.

Candidates must have current, valid authorization to work in the country where this role is located.