IDEAYA Biosciences
Director, Clinical Supply Chain
IDEAYA Biosciences, South San Francisco, California, us, 94083
Job Summary
About IDEAYA Biosciences . 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 to identify and validate translational biomarkers. We focus on synthetic lethality and antibody-drug conjugates (ADCs) for molecularly defined solid tumor indications. IDEAYA’s mission is to bring next‑wave precision oncology therapies that are more selective, effective, and deeply personalized to alter the course of disease and improve clinical outcomes for patients with cancer. For more information, please visit
www.ideayabio.com .
Position Summary We are seeking an experienced, strategic, resourceful, and highly motivated
Director, Clinical Drug Supply . This role requires an individual with demonstrated ability to operate effectively in a fast‑paced and evolving environment, engage cross‑functionally across departments, and communicate clearly and proactively across internal and external stakeholders. The ideal candidate will be a collaborative leader and critical thinker who can operate with autonomy, manage complex drug supply chains, and translate clinical development needs into actionable supply strategies. The successful candidate will manage a team responsible for the timely provision of clinical trial material (CTM) for all IDEAYA clinical trials, oversee vendor relationships, ensure compliance with global regulatory standards, and champion efficient processes to support the successful execution of global clinical trials. This position is based in our South San Francisco headquarters and requires onsite presence four days per week in accordance with company policy.
What you’ll do Clinical Trial Supply Management (General)
Manage a team of Clinical Supply Chain professionals to ensure continuous supply of CTM.
Implement a Clinical S&OP Process to align organization‑wide 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.
Develop an Inventory Management process to report global clinical inventory levels.
Interpret study protocols for study supply requirements, identify risks, and develop mitigation strategies.
Develop study‑specific Pharmacy Manuals and supply‑related training/instructional materials.
Ensure appropriate documentation of IP supply activities is provided to clinical teams for the Trial Master File.
Participate in 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 depots/sites as needed to support continued use.
Collaborate with study teams 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.
Vendor Management / Oversight
Serve as the primary point of contact for clinical packaging, labeling, distribution, and storage vendors.
Develop a governance process for effective vendor management.
Track performance, elevate issues, and ensure alignment with quality & regulatory expectations.
Lead vendor selection, RFPs, SOWs, and service agreements; ensure budget and scope alignment.
Review and approve vendor invoices and change orders; ensure cost efficiency and compliance.
Clinical Packaging and Labeling
Design, review, and approve investigational supply label text and proofs to meet specific country language(s) 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 per applicable regulations.
Plan for and manage expiry extensions, re‑labeling campaigns, and maintain retain samples appropriately.
IRT (Interactive Response Technology) Systems
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 within defined specifications.
Post IRT deployment, manage system updates for supply expiration date extensions and inventory management.
Serve as an escalation point for supply‑related issues received from sites.
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.
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.
Total Rewards IDEAYA offers a competitive total rewards package that reflects a pay‑for‑performance philosophy. Eligible employees may receive merit‑based salary increases, a company discretionary short‑term incentive plan participation, and company discretionary stock option awards (based on board approval). The comprehensive benefits package includes medical/dental/vision coverage (100% company paid for employees, 90% company paid for dependents), 401k, ESPP, and wellness programs.
EEO Statement IDEAYA complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires employees to be fully vaccinated from COVID‑19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two‑dose COVID‑19 vaccine series or a single‑dose COVID‑19 vaccine. (FDA approved or WHO listed for emergency use.)
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www.ideayabio.com .
Position Summary We are seeking an experienced, strategic, resourceful, and highly motivated
Director, Clinical Drug Supply . This role requires an individual with demonstrated ability to operate effectively in a fast‑paced and evolving environment, engage cross‑functionally across departments, and communicate clearly and proactively across internal and external stakeholders. The ideal candidate will be a collaborative leader and critical thinker who can operate with autonomy, manage complex drug supply chains, and translate clinical development needs into actionable supply strategies. The successful candidate will manage a team responsible for the timely provision of clinical trial material (CTM) for all IDEAYA clinical trials, oversee vendor relationships, ensure compliance with global regulatory standards, and champion efficient processes to support the successful execution of global clinical trials. This position is based in our South San Francisco headquarters and requires onsite presence four days per week in accordance with company policy.
What you’ll do Clinical Trial Supply Management (General)
Manage a team of Clinical Supply Chain professionals to ensure continuous supply of CTM.
Implement a Clinical S&OP Process to align organization‑wide 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.
Develop an Inventory Management process to report global clinical inventory levels.
Interpret study protocols for study supply requirements, identify risks, and develop mitigation strategies.
Develop study‑specific Pharmacy Manuals and supply‑related training/instructional materials.
Ensure appropriate documentation of IP supply activities is provided to clinical teams for the Trial Master File.
Participate in 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 depots/sites as needed to support continued use.
Collaborate with study teams 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.
Vendor Management / Oversight
Serve as the primary point of contact for clinical packaging, labeling, distribution, and storage vendors.
Develop a governance process for effective vendor management.
Track performance, elevate issues, and ensure alignment with quality & regulatory expectations.
Lead vendor selection, RFPs, SOWs, and service agreements; ensure budget and scope alignment.
Review and approve vendor invoices and change orders; ensure cost efficiency and compliance.
Clinical Packaging and Labeling
Design, review, and approve investigational supply label text and proofs to meet specific country language(s) 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 per applicable regulations.
Plan for and manage expiry extensions, re‑labeling campaigns, and maintain retain samples appropriately.
IRT (Interactive Response Technology) Systems
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 within defined specifications.
Post IRT deployment, manage system updates for supply expiration date extensions and inventory management.
Serve as an escalation point for supply‑related issues received from sites.
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.
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.
Total Rewards IDEAYA offers a competitive total rewards package that reflects a pay‑for‑performance philosophy. Eligible employees may receive merit‑based salary increases, a company discretionary short‑term incentive plan participation, and company discretionary stock option awards (based on board approval). The comprehensive benefits package includes medical/dental/vision coverage (100% company paid for employees, 90% company paid for dependents), 401k, ESPP, and wellness programs.
EEO Statement IDEAYA complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires employees to be fully vaccinated from COVID‑19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two‑dose COVID‑19 vaccine series or a single‑dose COVID‑19 vaccine. (FDA approved or WHO listed for emergency use.)
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