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Kailera Therapeutics · 2 weeks ago

Associate Director, Global Supply Chain

SD Metro Area

Full-time

Onsite

Lead/Staff

$160K/yr - $200K/yr

10+ years exp

Kailera Therapeutics is dedicated to developing therapies that empower individuals and enhance their health. The Associate Director, Global Supply Chain will oversee clinical supply management and project management to ensure the supply of Investigational Medicinal Products for clinical studies, while managing logistics and inventory throughout the trial lifecycle.

BiotechnologyPharmaceuticalTherapeutics

Responsibilities

Assist with investigational drug product supply and logistics activities, including, but not limited to, demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, returns, reconciliation, destruction, cold chain management, and inventory management

Maintaining oversight in monitoring inventory levels throughout the life of a clinical trial

Support with oversight of packaging and labeling/distribution vendors, including relationship management

Coordinate the preparation of clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, and coordinating the origination, proofing, and translation of clinical study labels and generation

Proactively identify potential issues, notify supervisor in a timely manner, and develop mitigating actions

Interpret clinical synopses and protocols to create clinical IMP demand forecasts

Attend clinical study and cross functional meetings as needed

Assist the global supply chain lead in overseeing the execution of multiple clinical trials and proactively identify potential supply chain issues and recommending solutions to global supply chain lead

Lead clinical study close-out activities, including returned goods reconciliation and inventory destruction

Assist with drug supply delivery through coordination of CMC efforts (including, but not limited to, CMC, Supply Chain, Legal, Procurement, Commercial, Regulatory, Clinical Development, and Clinical Operations)

Coordinate temperature excursion processes are executed as required

Support the IRT System Leads as necessary with regards to user requirement specifications and management module(s) as applicable

Lead organization and filing of documents on SharePoint sites