Sr. Manager, Clinical Supply Chain Operations

Arcus Biosciences

Arcus Biosciences

Operations
Posted on Tuesday, June 11, 2024

Description

Job Title: Senior Manager, Clinical Supply Chain Operations

Job Summary:

We are seeking a Senior Manager, Supply Chain Operations to provide day-to-day management of clinical supply products in support of their assigned Clinical Development Programs. The individual(s) in this role will be responsible for the packaging, labeling and distribution activities for specific clinical trials within the Arcus portfolio. This position will work with both internal and external customers, suppliers, and vendors to initiate, maintain, or closeout clinical trial supply related activities, ensuring that all project objectives are met in a timely, efficient, and high-quality manner. This is an in-house position and will report to Associate Director (or Director), Supply Chain Operations.

Responsibilities:

  • Works with internal functions (Clinical Operations, QA, Manufacturing, Regulatory, etc.) as well as external groups such as CRO, Depot, and Manufacturing companies to execute appropriate supply strategies, project timelines, and project plans to meet study requirements.
  • Coordinates with cross-functional project team to define study requirements for packaging/labeling, distribution, returns, reconciliation, and destruction. This includes creating protocol specific documentation (distribution instructions, packaging requests, labels, etc.), supply chain charter/maps/diagrams, and other study documentation as appropriate.
  • Manages daily activities for finished goods, packaging/labeling CMOs, and depot networks to ensure appropriate supplies are ordered, maintained, and distributed to clinical sites, based on industry standards and project specific requirements.
  • Responsible for ensuring inventory is reported accurately across systems (physical inventory vs. virtual inventory records).
  • Initiates packaging/labeling campaigns, trial supply storage, and distribution activities with domestic and international vendors/depots per study supply plans.
  • Manages, requests, and monitors shipments to depots and clinical sites via courier tracking, acknowledgement of receipt, cold chain product management (temperature excursions), etc. Oversees logistics for bulk shipments between contract manufacturing and depot facilities, including managing customs import/export activities.
  • Creates, reviews, and/or modifies SOPs for Supply Chain. Serve as supply chain Subject Matter Expert in creation/review/update of non-Supply Chain SOPs.
  • Utilize templates for create study-specific documentation for use during clinical trials (e.g. pharmacy manuals, request forms, excursion forms, etc.)
  • Manages contract, purchase order, and invoices/budget for clinical packaging/labeling and distribution vendors.
  • Serves as the Supply Chain representative on Study Management Team and other project teams as assigned.
  • Participates in the development of IRT systems (specifications review/performs UAT) and day-to-day management of IRT (re-supply strategy in IRT/supply inventory).
  • Provides guidance for returns for destruction and performs final IP reconciliation.
  • Duties as assigned

Qualifications:

  • 5+ years of relevant experience in the pharmaceutical or health care industry or equivalent, and a Bachelor’s degree, preferably in a scientific discipline
  • Direct experience in clinical trial supply activities is required
  • Understanding of pharmaceutical compliance regulations, such as GMPs, GCPs, and GDPs
  • Ability to establish priorities and collaborate with the study team, cross functional team members and external partners/vendors
  • Self-motivated, assertive, and able to function independently
  • Strong interpersonal and negotiation skills, as well as verbal and written communication skills
  • Able to develop solutions to a wide range of moderately complex problems
  • Good planning and organizational skills, coupled with strong time management skills
  • Aptitude for working with computer systems to plan and manage supply chain requirements
  • Core understanding of IRT system functionality is highly desired

This role can be based at our Brisbane, CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $155,000 - $180,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. 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 and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets

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3928 Point Eden Way I Hayward, CA 94545 – Arcus Biosciences is an equal opportunity employer