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.
Job 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
Education/Experience:
- 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
- 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
- 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
- Other qualitative requirements:
- Organizational skills
- Result-driven
- Strategic agility
- Resilience and flexibility dealing with ambiguity
Travel Required: Up to 10%
Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $109,000 - $135,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's geography, qualifications, skills, and experience.
At Structure, base pay is only one part of your total compensation package. 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.
