structuretx

structuretx

Sr. Associate, Clinical Supplies Planning and Logistics

South San Francisco, California · Senior

Sponsorship not specified$109k-$135kDetected 20 days ago
GCPNLPForecastingExcelSupply ChainLogisticsInventory ManagementClinical TrialsGMPFDA RegulatoryProblem SolvingOrganizational SkillsMicrosoft OfficeDemand PlanningGxPRegulatory Affairs

About the role

  • Structure is seeking a talented, independent, and highly motivated entry level Clinical Supplies Professional with experience in relevant fields.
  • Management of IP vendors: participates in packaging planning, label proof review, batch record review, weekly meetings, etc....
  • Works closely with QA to ensure compliance with IP documentation, procedures, Lot numbers, managing expiration dates, and coordinating release schedules,

Responsibilities

  • Collaborate with external partners (CMOs, CROs, shipping and IRT vendors, study sites) and study team members to ensure successful execution of clinical trials
  • Collaborate with Clinical Operations and Regulatory Affairs to provide packaging and labeling information, including labeling and packaging design in compliance with relevant SOPs, polices, and regulations
  • Participates in the review of IP-related study documents (e.g., pharmacy manual, IP section of protocol) and training materials for clinical study teams and investigational site use as needed.
  • Supports inspection team in preparation for and during regulatory agency inspection
  • Or supply chain management or packaging design in any industry with demonstrable knowledge of scientific principles

Requirements

  • Travel Required: Up to 10%

Nice to have

  • BA/BS required, scientific discipline, or Supply Chain management preferred
  • Experience in global logistics a plus
  • Knowledge of cGMP, GCP, GDP, and/or GLP strongly preferred
  • Experience in forecasting, labeling, and/or distribution management
  • 2+ years using Microsoft Office applications, including Excel, Smartsheets a plus
  • Strong sense of integrity, ethics and honesty

Skills

  • Action-oriented with excellent problem-solving skills

Compensation

  • For this role, the anticipated base pay range is $109,000 - $135,000.

Benefits

  • The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity.
  • Structure Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown.
  • Education/Experience:

Company info

  • Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company's platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.
  • Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed an initial public offering (IPO) in February 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.
  • Position Summary:
  • Structure is seeking a talented, independent, and highly motivated entry level Clinical Supplies Professional with experience in relevant fields. They will be involved in typical clinical supply activities including forecasting Investigational Product (IP) supply requirements, packaging, labeling, and inventory management, and managing distribution through 3rd party vendors, for multiple clinical trials. Tasks will include inventory tracking through spreadsheets and vendor portals, shipment tracking, packaging schedule tracking, electronic filing of documents, tracking quality events, and functional representation on study teams. Will collaborate and interact internally with Clinical Operations, Quality, Regulatory, Tech Ops/CMC and externally with Clinical Service Providers (e.g., IRT, CROs, IP Drug Depots.) This position will report to the Head of Clinical Supplies Planning and Logistics, in the Clinical Development Operations department.
  • Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology.
  • The company's platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs.
  • We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.
  • Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors.
  • The company completed an initial public offering (IPO) in February 2023.
  • With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.
  • They will be involved in typical clinical supply activities including forecasting Investigational Product (IP) supply requirements, packaging, labeling, and inventory management, and managing distribution through 3rd party vendors, for multiple clinical trials.
  • Tasks will include inventory tracking through spreadsheets and vendor portals, shipment tracking, packaging schedule tracking, electronic filing of documents, tracking quality events, and functional representation on study teams.
  • Will collaborate and interact internally with Clinical Operations, Quality, Regulatory, Tech Ops/CMC and externally with Clinical Service Providers (e.g., IRT, CROs, IP Drug Depots.) This position will report to the Head of Clinical Supplies Planning and Logistics, in the Clinical Development Operations department.
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