IDEAYA Biosciences
Director, Clinical Supply Chain
IDEAYA Biosciences, South San Francisco, California, us, 94083
IDEAYA Biosciences 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.
Location: South San Francisco, CA.
Position Summary We are seeking an experienced, strategic, resourceful, and highly motivated Director, Clinical Drug Supply. This role requires a leader able 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 collaborate across teams, think critically, and manage complex drug supply chains while translating clinical development needs into actionable supply strategies. The Director will manage a team responsible for the timely provision of clinical trial material (CTM) for all IDEAYA programs and oversee vendor relationships, ensure compliance with global regulatory standards, and champion efficient processes to support the successful execution of global clinical trials.
What you’ll do Clinical Trial Supply Management (General)
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.
Vendor Management/Oversight
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.
Clinical Packaging and Labeling
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.
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, 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.
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 our pay‑for‑performance philosophy. Employees are eligible for merit‑based salary increases, a company discretionary short‑term incentive plan, 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), 401(k), ESPP, and wellness programs.
The expected salary range for the role of Director, Clinical Supply Chain is $203,000 – $251,000. The final salary offered to a successful candidate will depend on several factors including office location, the candidate’s experience within their profession, experience in the disease areas we are targeting, length of time in the industry, educational background, and performance during the interview process.
The Company 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 a full vaccination against COVID‑19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers a candidate fully vaccinated once 14 days have passed since receiving the second dose in a two‑dose COVID‑19 vaccine series or a single‑dose vaccine. Vaccination must be FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside the U.S., be listed for emergency use by the World Health Organization.
IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.
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Location: South San Francisco, CA.
Position Summary We are seeking an experienced, strategic, resourceful, and highly motivated Director, Clinical Drug Supply. This role requires a leader able 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 collaborate across teams, think critically, and manage complex drug supply chains while translating clinical development needs into actionable supply strategies. The Director will manage a team responsible for the timely provision of clinical trial material (CTM) for all IDEAYA programs and oversee vendor relationships, ensure compliance with global regulatory standards, and champion efficient processes to support the successful execution of global clinical trials.
What you’ll do Clinical Trial Supply Management (General)
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.
Vendor Management/Oversight
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.
Clinical Packaging and Labeling
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.
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, 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.
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 our pay‑for‑performance philosophy. Employees are eligible for merit‑based salary increases, a company discretionary short‑term incentive plan, 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), 401(k), ESPP, and wellness programs.
The expected salary range for the role of Director, Clinical Supply Chain is $203,000 – $251,000. The final salary offered to a successful candidate will depend on several factors including office location, the candidate’s experience within their profession, experience in the disease areas we are targeting, length of time in the industry, educational background, and performance during the interview process.
The Company 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 a full vaccination against COVID‑19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers a candidate fully vaccinated once 14 days have passed since receiving the second dose in a two‑dose COVID‑19 vaccine series or a single‑dose vaccine. Vaccination must be FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside the U.S., be listed for emergency use by the World Health Organization.
IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.
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