Apply on Employer Site

IDEAYA Biosciences · 2 days ago

Director, Clinical Supply Chain

South San Francisco, CA

Full-time

Hybrid

Director/Executive

$203K/yr - $251K/yr

10+ years exp

IDEAYA Biosciences is a precision medicine oncology company focused on developing transformative therapies for cancer. They are seeking a Director of Clinical Supply Chain to manage clinical trial materials, oversee vendor relationships, and ensure compliance with regulatory standards while collaborating across departments to support clinical trials.

BiotechnologyHealth CareOncologyTherapeutics

Responsibilities

Manage a team of Clinical Supply Chain professionals to ensure that all IDEAYA clinical programs are continuously supplied with CTM

Working with Supply Chain Leadership, implement a Clinical S&OP Process to ensure organization wide alignment on the CTM requirements

Proactively manage study supply forecasts and inventory levels across depots and sites to prevent shortages or overages

Develop sourcing strategies for commercial comparator or adjunctive supplies, ensuring timely and cost-effective delivery to support all IDEAYA clinical programs

Develop Inventory Management process to ensure compliant and timely reporting of global clinical inventory levels

Interpret and advise on clinical trial protocols for study supply requirements and identify risks and develop mitigation strategies

Develop study specific Pharmacy Manuals and supply related training/instructional materials (i.e., Investigator Meeting and Site Initiation Visit slides, Dosing Cards, Diaries, etc.)

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

Establish and document the Supply Chain for each project as applicable to scope

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 ensure proper distribution of clinical supplies to study sites

Manage return and destruction of clinical supplies, with proper documentation of all steps

Provide documentation for global shipment of clinical supplies, e.g., proformas, customs documentation, and commercial invoices

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 the primary point of contact for clinical packaging, labeling, distribution, and storage vendors

Develop a governance process for effective management of these vendors

Track performance, escalate issues, and ensure alignment with quality and regulatory expectations

Lead vendor selection, RFPs, SOWs, and service agreements; ensure alignment with budget and scope

Review and approve vendor invoices and change orders; ensure cost efficiency and compliance

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 production of labels and packaging of clinical supplies

Liaise with appropriate parties to ensure adequate clinical study supply releases are obtained per applicable regulations (Qualified Person Release, Certificates of Analysis/Compliance, etc.). Plan for and manage expiry extensions, re-labeling campaigns, and ensure retain samples are maintained appropriately

Work with cross-functional teams 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

Perform unblinded IRT functionality monitoring to ensure resupply generation, etc. occur within defined specifications

Post IRT deployment, manage system updates for supply expiration date extensions, addition of new depot inventory, generation of manual re-supply shipments, evaluation of temperature excursions, etc

Serve as an escalation point for supply related issues received from sites

Qualification

Clinical Supply Chain ManagementPharmaceutical LogisticsGMPGCP KnowledgeVendor ManagementInteractive Response TechnologyClinical Trial Protocol InterpretationInventory ManagementStrategic PlanningMicrosoft Office SuiteCommunication SkillsDetail-orientedTeam Player

Required

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

The successful candidate will be a team player with integrity, a commitment to quality, and the ability to think critically and creatively in a fast-paced, changing environment

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