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Sr. Manager Clinical Supplies Planning and Logistics - South San Francisco, United States - Structure Therapeutics
Description
Job Description
Job DescriptionSalary: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 has completed an initial public offering (IPO) in February of 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 Senior Manager, Clinical Supplies Planning and Logistics with experience in clinical supply planning and logistics. This role is responsible for forecasting Investigational Product (IP) supply requirements, managing packaging, labeling, and distribution through 3rd party vendors, for one or more clinical trials. Collaborates and interacts internally with Clinical Operations, Medical Monitors, Program Management, Quality, Regulatory, CMC and externally with Clinical Service Providers (e.g., CROs, IP Drug Depot). This position will report to the Head of Clinical Supplies Planning and Logistics, in the Clinical Development Operations department. #LIHybrid
ESSENTIAL DUTIES AND RESPONSIBILITIES
· Manage all aspects of IP supply planning, logistics, and sourcing of comparator and ancillary supplies to ensure alignment with study plans, timelines, budget, and overall clinical development plan.
· Management of IP vendors (performance, quality, timelines, results, costs): participates in review of RFP, reviews IP services vendors budgets.
· Manages relationships 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.
· Manages clinical supply and logistics activities, including but not limited to demand forecasting and supply planning, IRT start-up through study closure, label generation and approval, packaging and labeling operations, release and distribution, temperature excursion, expiry extension, drug return and destruction records, and inventory management.
· Manages the design and 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 and master kit lists
REQUIREMENTS
Education
· BA/BS required, preferably in a 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.
· Experience in small molecules (capsule and tablet) clinical supply planning and logistics for multi-center, global studies required
· Experience in IP logistics in APAC (e.g., IP manufacturing and import from Asia to US) preferred
· Knowledge of global pharmaceutical regulatory requirements: cGMP, GCP, GDP
· Experience in operations and systems, including replenishment planning, capacity analysis, manufacturing, and distribution in either clinical or commercial environment
· Strong understanding and proven experience in IRT and other drug supply management systems, as well as experience in overseeing CROs and CDMOs
· Experience in operations and systems, including replenishment planning capacity analysis, manufacturing, and distribution in a clinical or manufacturing environment
· Knowledge of import/export policies
Core competencies and skills
· The ability to prioritize and handle multiple activities on a daily basis yet flexible and responsive to frequently shifting priorities
· Demonstrated ability to integrate into a remote team environment (US, APAC) with a positive attitude
· Action-oriented with excellent problem-solving skills
· Strong sense of ethics and honesty
· Other qualitative requirements:
o Organizational skills
o Result-driven
o Strategic agility
o Resilience and flexibility dealing with ambiguity
Travel
· Up to 20%
The target salary range for this full-time role is $164,000- $196,000 + bonus + equity + benefits. Structure Therapeutics determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education and training. More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.
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