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Senior Clinical Supplies Manager

10 April 16, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Title:

Senior Clinical Supplies Manager


Job Location:

Alameda, California, USA


Company:

Exelixis


Job Type:

Full-time


Role Overview:

The Senior Clinical Supplies Manager at Exelixis oversees all clinical supply management aspects, including packaging, labeling, inventory monitoring, and distribution coordination. This role works closely with internal teams and external vendors/CMOs to ensure the timely and compliant supply of Investigational Medicinal Products (IMP) for global clinical trials.


Key Responsibilities:

  • Lead clinical supply operations from study start-up through closure using IRT systems.

  • Coordinate labeling, packaging, release, and distribution with CMOs and vendors.

  • Create forecasts and packaging designs aligned with trial needs.

  • Ensure global distribution readiness and regulatory compliance.

  • Participate in IRT development, UAT, and system specifications.

  • Develop and review clinical labels according to global regulations.

  • Represent clinical supplies at cross-functional meetings and manage project timelines.

  • Maintain inspection readiness and TMF documentation using relevant software tools.


Education & Experience:

  • BS/BA in a related discipline with 9+ years of experience, or

  • MS/MA with 7+ years of experience, or

  • Equivalent combination of education and relevant experience.

  • Certification in clinical supply management is a plus.


Preferred Experience:

  • Clinical supply planning and distribution using contract manufacturing organizations (CMOs).

  • Hands-on experience with IRT systems (IVRS/IWRS).

  • Familiarity with GMP batch records and global supply chain logistics.


Skills & Competencies:

  • Strong understanding of GCP/GMP/GLP and regulatory standards.

  • Knowledge of clinical labeling and distribution regulations.

  • Excellent project management and communication skills.

  • Ability to work in a fast-paced, evolving environment.

  • Analytical thinking and cross-functional collaboration skills.


Working Conditions:

  • Up to 20% travel (vendor sites, team meetings, other offices).


Compensation & Benefits:

  • Base Salary: $138,000 – $196,000 annually (based on location and experience)

  • Additional Benefits:

    • 401k with company contributions

    • Medical, dental, vision insurance

    • Life & disability insurance

    • FSAs

    • Annual bonus or sales incentive (as applicable)

    • Stock purchase plan and long-term incentives

    • 15 vacation days in year one

    • 17 holidays including December shutdown

    • Up to 10 sick days per year