Sr. Associate, Clinical Supplies Planning and Logistics

Structure Therapeutics•South San Francisco, CA

16d•$109,000 - $135,000

About The Position

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.

Requirements

BA/BS required, scientific discipline, or Supply Chain management preferred
3+ years of relevant experience in one or more of the following areas: Clinical Supplies, QA, manufacturing, process development, materials management, and/or analytical development in a GxP environment in the biotechnology/pharmaceutical industry. Or supply chain management or packaging design in any industry with demonstrable knowledge of scientific principles
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
The ability to prioritize and handle multiple activities on a daily basis while being flexible and responsive to frequently shifting priorities
Demonstrated ability to integrate into a partially remote team environment (US, EU, LATAM, APAC) with a positive attitude
Action-oriented with excellent problem-solving skills
Strong sense of integrity, ethics and honesty
Organizational skills
Result-driven
Strategic agility
Resilience and flexibility dealing with ambiguity

Nice To Haves

Experience in global logistics a plus

Responsibilities

As part of the Clinical Supplies Planning and Logistics team, participates in clinical supply and logistics activities, including but not limited to demand forecasting and supply planning, label text generation and approval, packaging and labeling operations at clinical supply vendors, batch record review, distribution management, temperature excursion, expiry extension, drug return and destruction records, and inventory management.
Management of IP vendors: participates in packaging planning, label proof review, batch record review, weekly meetings, etc....
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
Works closely with QA to ensure compliance with IP documentation, procedures, Lot numbers, managing expiration dates, and coordinating release schedules,
Tracking GCP adherence at sites
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
Ensures appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File
Provides input to and review of drug kit randomization specifications and master kit lists