Associate Director, CMC Clinical Drug Supply & Logistics

Ideaya Biosciences • South San Francisco, CA

121d • $192,000 - $237,000 • Remote

About The Position

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer. When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward.

Requirements

• A minimum of a BS/BA in Supply Chain Management, or related field.
• A minimum of 7 years of clinical drug supply management experience demonstrating a progressively increasing scope of responsibility.
• Experience in leading cross-functional groups.
• Late phase and commercial experience are a plus.
• Must be an expert in GXP requirements and knowledgeable of industry service providers, trends, and challenges.
• A strong understanding of regulatory requirements impacting the clinical drug supply chain.
• Analytical skills with the ability to forecast and manage supply chain risks and inventory.
• Demonstrated knowledge and application of building and enhancing IRT systems.
• Experience with global comparator sourcing.
• Knowledge of trade compliance and VAT reclamation.
• Ability to create a collaborative environment and manage multiple project activities with global contract CDMOs.
• Experience in managing international CMOs, reviewing documentation, and ensuring proper guidelines are followed.
• Exceptional problem-solving skills and ability to quickly adapt and shift focus as needed.

Responsibilities

• Manage investigational product supply planning/forecasting for multiple domestic and global clinical trials to ensure alignment with study activity and timelines
• Collaborate with the CMC and clinical team in developing CTM supply requirements planning based on forecasts
• Participate in relevant team meetings providing clinical supply status reports and support
• Establish and document the supply chain for each project as applicable to the scope
• Vendor Management/Oversight as a point of contact for third-party packaging, distribution, and storage
• IRT (Interactive Response Technology) Systems, design, review specifications, build, perform user acceptance testing (UAT), deployment, maintain, monitor, enhance systems
• Preparation of label text, translations, and proofs that align with country requirements, review of executed labeling batch records, overseeing release
• Liaise with QA and other appropriate parties to ensure timely review and approval of batch records for packaging and labeling per applicable regulations
• Collaborate with the study team and vendors to ensure proper distribution of clinical supplies to study sites
• Revise study specific Pharmacy Manuals and supply-related training/instructional materials based on protocol amendments
• Monitor inventory levels at sites and depots through the life of a trial taking preventative actions to avoid potential supply issues
• Follow-up on reported Temperature Excursions and/or Product Complaints from sites/depots
• Ensure expiry extensions are provided to depot/sites as needed to support continued use
• Serve as an escalation point for supply-related issues received from sites
• Provide and/or support documentation for global shipment of clinical supplies, e.g., proformas and commercial invoice
• Filing appropriate documentation for IP supply activities in the Trial Master File
• Manage return and destruction of clinical supplies, with proper documentation of all steps
• Ensure activities are performed on time and with good quality, in compliance with Regulatory Authorities' regulations / guidelines and IDEAYA's policies.

Benefits

• Medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents)
• 401k
• ESPP
• Wellness programs
• Merit-based salary increases
• Company discretionary short-term incentive plan participation
• Company discretionary stock option awards (based on board approval)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree