Exel

Exel

Associate Clinical Supply Chain Director

Alameda, CA · Director

Sponsorship not specified$161k-$228kDetected 5 days ago
GCPProject ManagementStakeholder ManagementForecastingSupply ChainClinical TrialsGMPFDA RegulatoryCommunicationCollaborationProblem SolvingMentoringOrganizational SkillsMicrosoft OfficeRegulatory Affairs

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odds of building a lasting career here

61Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

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Employer immigration record

from this employer's Department of Labor filings

Green-card filing pattern in this occupation

Context, not a finding about this posting: of this employer's 3 green-card filings in this occupation, 100% were for a worker who already held the job.

Files H-1B transfers

1 transfer filing in the last year, covering 1 worker. Median labor-condition decision: 9 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

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About the role

  • The base pay range for this position is $161,000 - $228,000 annually.
  • The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location.
  • The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

Responsibilities

  • Create and manage clinical forecast plans and budgets related to drug product, and clinical supplies for multiple programs and study levels, based on clinical study protocol and clinical development plans.
  • Create global supply strategies, supply plans to support clinical studies; collaborate with Pharmaceutical Operations, Clinical Operations, Regulatory Affairs, Quality Assurance, and external vendors to execute the strategies for the clinical studies.
  • Manage clinical trial supply to ensure timely IMP production; manage inventory and worldwide distribution activities; ensure uninterrupted supply.
  • Manage label development process from generation of the master label text to label printing.
  • Lead the development, review and User Acceptance Testing (UAT) of the Interactive Response Technology (IRT) system.
  • Co-lead the development of pharmacy documents, manuals and other tools with Clinical Operation team.
  • Utilize appropriate software and IT systems (e.g. IRT, MS Office, MS Project, Smartsheets, and others) to effectively manage key project activities.
  • The Associate Clinical Supplies Director designs, develops, and implements the clinical supplies strategy to ensure appropriate processes are established and clinical supplies deliverables are met for clinical trials.
  • This individual also manages clinical supply activities including planning and forecasting of clinical supply, oversight of clinical packaging, labeling, and distribution operations at contracted manufacturing organizations (CMOs).
  • The AD partners with other functional leaders in CMC, Regulatory Affairs, Clinical Operation and Quality Assurance in support of the study project teams and ensures timely drug supply for clinical trials.

Requirements

  • BS/BA degree in related discipline and a minimum of eleven years of related experience
  • MS/MA degree in related discipline and a minimum of nine years of related experience
  • It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

Nice to have

  • Experience in independently leading all aspects of clinical supplies management for Phase I, II and especially Phase III trials as well as investigator sponsored trials (/IST)
  • Experience with IRT systems for drug supply management.
  • Clinical Supply management experience using contract manufacturing companies strongly preferred.

Skills

  • Strong knowledge and demonstrated experience in clinical supply management- planning, labeling, packaging and distribution
  • Knowledge of GMP batch record development, review, and approval processes
  • Working knowledge of regulations relating to clinical labeling, packaging and distribution activities.
  • Working knowledge of GMP/GCP/GLP/GDP regulations
  • Excellent oral and written communication skills; along with strong demonstrated stakeholder management skills
  • Excellent project management and organizational skills; ability to plan and execute multiple on-going projects with ease
  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
  • May also work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
  • Exercises good business and technical judgment in selecting methods, techniques and evaluation criteria for obtaining results.
  • Education/Experience:
  • BS/BA degree in related discipline and a minimum of eleven years of related experience; or,
  • MS/MA degree in related discipline and a minimum of nine years of related experience; or,

Compensation

  • The base pay range for this position is $161,000 - $228,000 annually.
  • The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location.

Benefits

  • Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.

Company info

  • Represent Clinical Supplies function at clinical trial team meetings; communicate plans and timelines to internal and external customers and partners.
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