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About Us:
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 Clinical Supplies Professional with experience in clinical supply planning and logistics. They will be involved in typical clinical supply manager activities including forecasting Investigational Product (IP) supply requirements, inventory management, and managing packaging, labeling, and distribution through 3rd party vendors, for one or more clinical trials. Will collaborate and interact internally with Clinical Operations, Medical Monitors, Program Management, Quality, Regulatory, Tech Ops/CMC and externally with Clinical Service Providers (e.g., IRT, CROs, IP Drug Depots). This position will report to the Assoc. Director of Clinical Supplies Planning and Logistics, in the Clinical Development Operations department.
ESSENTIAL DUTIES AND RESPONSIBILITIES

• As part of the Clinical Supplies Planning and Logistics team, manages 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 and release, distribution management, temperature excursion, expiry extension, drug return and destruction records, and inventory management.
• Management of IP vendors (performance, quality, timelines, results, costs): participates in review of quotes, packaging planning, label proof review, batch record review, etc....
• Collaborates with external partners (CMOs, CROs, shipping and IRT vendors, study sites) and study team members to ensure successful execution of clinical trials
• Collaborates with Clinical Operations and Regulatory Affairs to provide packaging and labeling strategy, including labeling and packaging design in compliance with relevant SOPs, polices, and regulations
• Works closely with QA to ensure compliance around IP documentation, procedures, Lot numbers, managing expiration dates, and coordinating release schedules, and 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 drug kit randomization specifications and reviews master kit lists

Qualifications:
Education

• BA/BS required, scientific discipline preferred. Other BA/BS degree with clinical supply experience will be considered.

Experience

• 6+ years of relevant experience in the biotechnology/pharmaceutical industry, including at least 3 years in clinical supply management in a small biotech-type of environment
• Clinical Supplies management in blinded studies
• Experience in small molecules (capsule and tablet) clinical supply planning and logistics for multi-center, blinded global studies preferred
• Experience in global IP logistics a plus
• Knowledge of cGMP, GCP, GDP
• Experience in forecasting, labeling, and distribution in a clinical environment

Core competencies and Skills

• 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, 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 Inc. is an Equal-Opportunity Employer.
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 $161,000 - $190,000. 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.
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Structure Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.
We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.
Structure Therapeutics' receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Structure Therapeutics and such organization and will be considered unsolicited and Structure Therapeutics will not be responsible for related fees.
Fraud Alert
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Recruiters will always contact you using the domain of Structuretx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Structure Therapeutics, please email human resources.