Director, Clinical Drug Supply

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

• Bachelor's Degree or higher in health or life sciences.
• 10+ years' experience in the pharmaceutical/biotechnology industry performing international clinical drug supply logistics/management.
• Proven success working across global, multi-site clinical studies at all phases (I-III), including NDA preparation.
• Experience interpreting clinical study protocols and developing well-planned, accurately forecasted clinical supply plans/forecasts.
• Strong working knowledge of GMP, GCP, ICH guidelines, and regional/global regulatory expectations.
• Experience with Interactive Voice/Web Response System (IRT) design, implementation, user testing and monitoring.
• Demonstrated success working with CMOs, managing external partnerships, and navigating evolving program priorities.
• Strong communication skills with the ability to influence internal stakeholders and external vendors.
• Organized, detail-oriented, and capable of strategic planning and tactical execution.
• Proficiency in Microsoft Office Suite and experience with collaborative platforms (e.g., SharePoint, Box) and inventory systems.
• Willingness and ability to travel domestically and internationally as needed.

Responsibilities

• Interpret and advise on clinical trial protocols for study supply requirements/challenges and risk mitigation strategies.
• Develop study specific Pharmacy Manuals and supply related training/instructional materials.
• Ensure appropriate documentation of Investigational Product (IP) supply activities is provided to clinical trial teams for the Trial Master File.
• Participate in relevant team meetings providing clinical supply status reports and support.
• Proactively manage study supply forecasts and inventory across depots and sites; prevent shortages or overages.
• Establish and document supply chain for each project as applicable to scope.
• Coordinate procurement and timely delivery of commercial comparator or adjunctive supplies.
• Handle temperature excursion investigations, product complaints, expiry management, and re-labeling as needed.
• Ensure expiry extensions are provided to depot/sites as needed to support continued use.
• Collaborate with study team and vendors to assure proper distribution of clinical supplies to study sites.
• Manage return and destruction of clinical supplies, with proper documentation of all steps.
• Collaborate with the CMC and clinical team in developing CTM supply requirements planning based on forecasts generated by Clinical Operations.
• Provide and/or support documentation for global shipment of clinical supplies.
• Develop excellent working relationships with QA and Regulatory for timely review and approval of batch records for packaging and labeling of study drug.
• Serve as primary point of contact for third party packaging, labeling, distribution, and storage Vendors.
• Lead vendor selection, RFPs, SOWs, and service agreements; ensure alignment with budget and scope.
• Review and approve vendor plans, invoices, and change orders; ensure cost efficiency and compliance.
• Track performance, escalate issues, and ensure alignment with quality and regulatory expectations.
• Design/review/approve investigational supply label text and proofs to meet specific country language(s), translations and regulatory requirements.
• Develop/review/approve clinical supply packaging configurations and specifications.
• Plan and coordinate Vendor activities for scheduling and production of labels and primary/secondary packaging of clinical supplies.
• Liaise with appropriate parties to ensure adequate clinical study supply releases are obtained per applicable regulations.
• Work with cross-functional team to develop study-specific IRT specifications and requirements.
• Perform user acceptance testing (UAT).
• Perform unblinded monitoring of IRT inventory at depots/sites with respect to recruitment.
• Manage system updates for supply expiration date extensions, addition of new depot inventory, generation of manual re-supply shipments, evaluation of temperature excursions.

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: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree