Associate Director, Supply Chain Business Processes

Description
Job Summary:
We are seeking an Associate Director, Supply Chain Business Processes to be responsible for developing, implementing, and supporting “best operating practices” across the Arcus portfolio, along with directly managing Clinical Trial Supplies for their assigned trials. Our ideal candidate is someone who can coordinate and facilitate strategic process development, with a focus on packaging, labeling and distribution operations. This is a fully remote position reporting to the Head of the Supply Chain Business Processes group, as part of the Global Supply Chain team, with excellent growth and cross functional learning opportunities in a rapidly growing biotech company. The successful candidate will split their time between Business Processes and Supply Chain Operations activities. Please note: Due to the highly industry specific nature of this role, candidates without experience in a biotech or pharma organization will not be considered.
Responsibilities
In this role you would be responsible for (but not limited to):

• Supporting and leading assigned Business Process Initiatives, including but not limited to Label Development and late phase/pre-commercial focused process improvements.
• Ensuring appropriate supplies are ordered, maintained, and distributed to clinical sites, based on industry standards and project-specific requirements.
• Coordinating with project team in the pre-project planning phase to define trial requirements (documents, drug products, forms and/or ancillary labeling, if required). This includes creating trial specific Distribution Instructions, Drug Shipment Request templates, and other study documentation, as appropriate.
• Coordinating trial supply storage, labeling/packaging, and distribution activities with domestic and international vendors/depots per trial supply plans.
• Working with third-party vendors to ensure accurate counts (physical inventory vs. virtual inventory records).
• Working with both internal and external customers as well as third-party vendors to assist in development and communication of trial supply project costs, trial supply plans, and processes to perform quality project execution, ensuring that all project objectives are met in a timely, efficient, and high-quality manner.
• Providing guidance for returns for destruction and performing final IP reconciliation.
• Serving as Supply Chain Lead for assigned trials in the Arcus clinical development portfolio. In this role, the individual will be responsible for:
• Managing and monitoring shipments to clinical sites, e.g., courier tracking, acknowledgement of receipt, cold chain product management (i.e., Temperature Excursion management), etc.
• Managing and monitoring the overall bulk product inventory.
• Managing PO generation and invoice approvals for storage and clinical packaging/labeling/distribution vendors.
• Participating in the set-up of IRT systems (specifications review/UAT) and day-to-day management of IRT (re-supply strategy in IRT/supply inventory).
• Creating, reviewing, and modifying SOPs, Work Instructions, and Forms for Clinical Trial Supply related activities, as well as for generating templates for use during Clinical Trials (Pharmacy Manuals, Material Packaging Request forms, Temperature Excursion management forms, etc.)
• Serving as the Supply Chain representative on Study Management Teams and other project teams as assigned.
• Overseeing logistics for bulk shipments between contract manufacturing and depot facilities, including managing customs import/export activities.
• E xecuting appropriate supply strategies, project timelines, and project plans to meet trial requirements.
• Coordinating and managing projects and providing oversight of third-party vendors in support of Business Process initiatives.

Qualifications

• Aptitude for working with computer systems to plan and manage supply chain requirements
• Direct experience in clinical trial supply activities is required
• Understanding of pharmaceutical compliance regulations, such as GMPs, GCPs, and GDPs
• Core understanding of IRT system functionality is highly desired
• Strong interpersonal and negotiation skills, as well as verbal and written communication skills
• Self-motivated, assertive, and able to function independently
• Good planning and organizational skills, coupled with strong time management and project planning skills
• Ability to establish priorities and collaborate with the study team, cross functional team members and external partners/vendors
• 7+ years of relevant experience in the pharmaceutical or health care industry or equivalent, and a Bachelor’s degree, preferably in a business related discipline. (Please note: Due to the highly industry specific nature of this role, candidates without experience in a biotech or pharma organization will not be considered.)
• Able to develop solutions to a wide range of moderately complex problems

This role is remote based. The anticipated salary range for fully qualified candidates applying for this position is $165,000 - $185,000. For remote-based candidates, the salary range may vary based on local market data. Factors such as relevant experience, education, duration of experience, and length of industry experience will influence the actual salary offered. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers/.
Arcus Biosciences is an Equal Opportunity Employer.