Manager Clinical Supplies Planning and Logistics

Structure Therapeutics • South San Francisco, CA

2d • $144,000 - $172,500

About The Position

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.
• 4+ years of relevant experience in the biotechnology/pharmaceutical industry, including at least 2 years in clinical supply management in a small biotech-type of environment
• Clinical Supplies management in blinded studies
• 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 preferred
• Experience in global IP logistics a plus

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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager