Sr. Manager Clinical Supplies Planning and Logistics

Structure Therapeutics•South San Francisco, CA

4d•Hybrid

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. 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.

Requirements

BA/BS required, scientific discipline preferred. Other BA/BS degree with clinical supply experience will be considered.
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
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
Organizational skills
Result-driven
Strategic agility
Resilience and flexibility dealing with ambiguity

Nice To Haves

Experience in small molecules (capsule and tablet) clinical supply planning and logistics for multi-center, blinded global studies
Experience in global IP logistics

Responsibilities

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