Associate Director, Clinical Supply Management

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. 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

Responsible for coordination of investigational medicinal product (IMP) and ancillary supply planning, forecasting, labeling, packaging, distribution, inventory monitoring, and reconciliation for assigned clinical studies. This position reports to the Director, Clinical Supply Management.

Responsibilities

• Collaborate cross-functionally with Clinical Operations, Manufacturing, Regulatory Affairs, and Quality Assurance to plan and execute IMP supply planning including 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
• 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
• 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
• Serve as liaison between Clinical Operations and Quality Assurance to manage IMP shelf-life extensions, temperature deviation management, product complaints, and associated investigations
• Assist in the process of identifying potential supply chain vendors, reviewing proposals contributing to the selection process
  
  

Requirements

• BS in Business Administration, Supply Chain/Logistics, Engineering, or other field related to the essential duties of this role.
• Minimum of 5 years in clinical supply chain management function
• Experience with electronic interactive response technologies for inventory management
• Thorough understanding of GMP, GCP, and ICH standards governing IMP labeling, packaging, and global distribution
• Solid vendor management skills
• Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner
• Proficient in MS Office (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 cross-functional team members
• Exceptional organizational skills with the ability to multi-task and prioritize
• Attention to detail
  
  

Preferred:

• MBA or advanced life science degree
  
  

California pay range

$170,000—$190,000 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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