BioSpace
Non-Solicitation Policy And Notice To Agencies And Recruiters
IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships. Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to humanresources@ideayabio.com. We ask that you only email your interest once.
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.
Location: South San Francisco, CA.
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. This individual will manage a team responsible for the timely provision of clinical trial material (CTM) for all clinical trials of IDEAYA programs and will oversee vendor relationships, ensure compliance with global regulatory standards, and champion efficient processes to support the successful execution of global clinical trials. The position is based at our South San Francisco headquarters and requires onsite presence four days per week.
Reporting to: VP/SVP, Clinical and Commercial Supply Chain.
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, elevate 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 Along with our inspiring mission and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 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.
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.
This position requires you to work onsite in the office at the Company’s facilities for training & meetings, with work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you 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. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.
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IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships. Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to humanresources@ideayabio.com. We ask that you only email your interest once.
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.
Location: South San Francisco, CA.
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. This individual will manage a team responsible for the timely provision of clinical trial material (CTM) for all clinical trials of IDEAYA programs and will oversee vendor relationships, ensure compliance with global regulatory standards, and champion efficient processes to support the successful execution of global clinical trials. The position is based at our South San Francisco headquarters and requires onsite presence four days per week.
Reporting to: VP/SVP, Clinical and Commercial Supply Chain.
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, elevate 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 Along with our inspiring mission and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 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.
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.
This position requires you to work onsite in the office at the Company’s facilities for training & meetings, with work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you 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. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.
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