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Kailera Therapeutics · 2 weeks ago

Director, Global Supply Chain

Greater Boston

Contract

Onsite

Director/Executive

$175K/yr - $230K/yr

8+ years exp

Kailera Therapeutics is committed to developing therapies for obesity and related conditions. The Director, Global Supply Chain will manage drug product supply and logistics activities, ensuring uninterrupted supply for clinical studies and commercial products while collaborating with internal functional groups.

BiotechnologyPharmaceuticalTherapeutics

Responsibilities

Managing 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, cold chain management, and inventory management

Communicating supply strategies and supply needs to CMC stakeholders and providing input for developing manufacturing strategies to support those needs

Providing oversight in monitoring inventory levels throughout the life of a clinical trial or commercial product, including taking preventative actions to avoid potential supply issues

Providing day-to-day oversight of packaging and labeling/distribution vendors, including relationship management

Contributing to the preparation of clinical protocols, 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 management in a timely manner, and develop mitigating actions

Interpret clinical synopses and protocols to create clinical IMP demand forecasts

Oversee the execution of multiple clinical trials and proactively identify potential supply chain issues, including providing analysis and recommending solutions with appropriate support from SMEs

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

Manage and execute drug supply delivery through coordination of CMC efforts assigned to the entire project team (including, but not limited to, CMC, Supply Chain, Legal, Procurement, Commercial, Regulatory, Clinical Development, and Clinical Operations)

Ensure temperature excursion processes are executed as required

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

Leverage inventory management capabilities of the IRT to appropriately manage clinical and commercial drug supply

Qualification

Clinical supply managementGlobal regulatory requirementsProject managementIRT systemsPharmaceutical developmentInventory managementComputer skillsCollaborationProblem-solvingCommunication

Required

Bachelor's degree and 10+ years of relevant biopharmaceutical industry experience or an advanced degree with 8+ years

8+ years of experience in clinical supply management

Experience with global pharmaceutical development and manufacturing operations for development-stage and/or commercial products, including formulation development (pre-filled syringes, solid oral dosage forms, etc.), analytical development, and device development

Deep understanding of IRT systems

Ability to create a collaborative environment and manage multiple project activities with global contract CDMOs

Strong computer skills including MS Office

Hands-on, roll-up-your-sleeves, collaborative approach with high sense of urgency and drive for results

Ability to think outside of the box and challenge the status quo

Desire to work in a fast-paced, innovative environment

Domestic or international travel is required (up to 20%)