Exel

Exel

Clinical Supply Chain Director

Alameda, CA · Director

Sponsorship not specified$165k-$235kDetected 7 days ago
GCPSupply ChainProcurementGMPFDA RegulatoryCommunicationCollaborationMicrosoft Office

About the role

  • Evaluates the impact of changing the inventory targets, clinical demand, and budget restrictions.
  • JOB COMPLEXITY: - Works on very complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
  • The base pay range for this position is $164,500 - $234,500 annually.

Responsibilities

  • Responsible for developing and implementing departmental technical SOPs, business procedures and infrastructure to drive consistent and streamlined processes that improve business effectiveness.
  • Responsible for building vendor capabilities and knowledge to enable vendor selection.
  • Responsible for oversight of scheduling and delivery of clinical supplies including strategies for creating label and packaging design, randomization, packaging, labeling and distribution in compliance with Good Manufacturing Practices (GMP) regulations.
  • Manages the inventories based upon targets and various regulatory filings (initial approvals and process changes in all countries).
  • Works collaboratively with other Pharmaceutical Sciences functions, Clinical and Non-Clinical Teams in the strategic sourcing of vendors to support the development supply chain.
  • Mentors teammates and leads in a matrix environment.
  • Performs supply forecast modeling (short, medium and long-term).
  • The Clinical Supplies Director is responsible for developing and implementing clinical supply chain procedures and infrastructure to support the upcoming pipeline of both small molecule and biologics projects.
  • Also responsible for developing clinical supply chain strategies ensuring availability of supply through development and commercial launch, as well as transferring sustaining activities to the appropriate site planning and procurement teams.

Requirements

  • BS/BA degree in related discipline and a minimum of thirteen years of related experience
  • MS/MA degree in related discipline and a minimum of eleven years of related experience
  • Technical experience, in drug product manufacturing, analytical testing/QC, and Pharmacy packaging, and labeling operations as required in meeting FDA guidelines.
  • Demonstrated knowledge of manufacturing and production planning techniques and the tools used in the industry to streamline the planning process.
  • Demonstrated 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)
  • Working knowledge of GMP/GCP/GLP regulations required.
  • 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.
  • Manages the procurement of comparator drug products and matching placebo as required.

Skills

  • Strong knowledge and demonstrated experience of clinical supply management - planning, labeling, packaging and distribution
  • Clinical Supply operations experience either in in-house facilities or working at a CMO is required
  • Has complete understanding and wide application of technical principles, theories, concepts and techniques.
  • Has good general knowledge of other related disciplines.
  • Applies strong analytical and business communication skills.
  • Proficient with broad use computer applications such as MS Office and specialized applications as needed for job.
  • Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
  • Creates formal networks involving coordination among groups.
  • Education/Experience:
  • BS/BA degree in related discipline and a minimum of thirteen years of related experience; or,
  • MS/MA degree in related discipline and a minimum of eleven years of related experience; or,
  • PhD in related discipline and a minimum of eight years of related experience; or,

Compensation

  • The base pay range for this position is $164,500 - $234,500 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

  • The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
  • Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.
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