Associate Director, Clinical Supplies Planning and Logistics

Structure Therapeutics•South San Francisco, CA

15h•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. Position Summary: Structure is seeking a talented, independent, and highly motivated Associate Director, Clinical Supplies Planning and Logistics (CSPL) 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. Developing strategy for later phase global clinical trials. Contributing to the budgeting and finance functions within CSPL. 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.

Requirements

BA/BS required, preferably in a scientific discipline. Other BA/BS degree with clinical supply experience will be considered.
10+ years of relevant experience in the biotechnology/pharmaceutical industry, including at least 6 years in clinical supply management in a small biotech-type of environment.
Experience in small molecules (capsule and tablet) clinical supply planning and logistics for multi-center, blinded global studies required
Experience in IP logistics in APAC (e.g., IP manufacturing and import from Asia to US) preferred
Experience managing clinical supplies in large, global trials.
Knowledge of global pharmaceutical regulatory requirements: cGMP, GCP, GDP
Experience in forecasting, labeling, and distribution in clinical environment
Understanding and proven experience in IRT/RTSM, Clinical Supply and similar vendor management experience
Knowledge of import/export policies
The ability to prioritize and handle multiple activities on a daily basis while being flexible and responsive to frequently shifting priorities
Cross-functional leadership
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
Organizational skills
Result-driven
Strategic agility
Resilience and flexibility dealing with ambiguity

Nice To Haves

Experience in IP logistics in APAC (e.g., IP manufacturing and import from Asia to US) preferred

Responsibilities

Manage all aspects of IP supply planning and logistics, to ensure alignment with study plans, timelines, budget, and overall clinical development plan.
Management of IP vendors (performance, quality, timelines, results, costs): Vendor selection, RFPs, quotes.
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 SOPs. 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, Blinding strategies and maintaining the blind, 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.
Provides input to drug kit randomization specifications and reviews and master kit lists.
Manage the design and review of IP-related study documents (e.g., pharmacy manual, IP section of protocol, SOPs) 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.
Line manager for one or more direct reports