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About the Role

IDEAYA is seeking an Associate Director of Clinical Supply Chain to provide execution support for all aspects of clinical trial materials (CTM) for all clinical trials of IDEAYA programs. This position will support the leadership of Clinical Supply Chain in planning, forecasting, material sourcing, packaging and labeling, distribution, return and destruction of IDEAYA investigational drugs. The role requires close coordination and collaboration with stakeholders across multiple functional areas within IDEAYA.

Responsibilities

Assist with identification and management of external global partners (e.g., depots, couriers, CMOs, IRT vendors) to ensure availability of drug supply at depots/clinical trial sites.
Lead and assist with developing, maintaining, and implementing supply chain policies, procedures, systems and techniques with a focus on continuous improvements.
As requested, assist with the preparation of the departmental budget, collaborate with Finance to address budget and invoice inquiries.
Create and/or revise study specific Pharmacy Manuals and supply related training/instructional materials based on protocol requirements.
Ensure appropriate documentation of IP supply activities is filed for the Trial Master File.
Participate in relevant team meetings providing clinical supply status and support.
Manage supply planning/demand forecasting to ensure alignment with study activity and timelines.
Monitor inventory levels at clinical sites and depots throughout the life of a trial taking preventative actions to avoid potential supply issues.
Establish and document a supply plan for each project as applicable.
Assist with procurement and management of commercially sourced supplies.
Follow-up and resolve Temperature Excursions and/or Product Complaints from sites/depots.
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 provided by Clinical Operations.
Provide and/or support documentation for global shipment of clinical supplies, e.g., proformas and commercial invoice.
Support QA with timely review and approval of batch records for packaging and labeling of study drug.
Serve as point of contact for third party packaging, labeling, distribution, storage Vendors, and CRO for assigned projects representing Clinical Supply Chain.
Serve as the point of contact for study specific IRT URS, UAT and enhancements in support of clinical supply management.
Preparation of label text, coordination of label translations and proofs that align with county specific regulatory requirements.
Review of pre and post executed labeling batch records.
Liaise with appropriate parties to ensure adequate clinical study supply releases are obtained per applicable regulations.
Coordinate expiry date extensions and re-labeling operations, when applicable.
Oversee maintenance of appropriate quantity of retain samples.
Work with cross-functional teams to develop study-specific IRT specifications and requirements from a Clinical Supply perspective.
Perform user acceptance testing (UAT).
Perform unblinded monitoring of IRT inventory at depots/sites with respect to recruitment.
Perform unblinded IRT functionality monitoring to assure 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 the point of contact for supply related issues reported by clinical sites and managed within the IRT.
Oversee and prepare documentation to support import/export of globally transferred CTM as needed.
Support movement of CTM from depots to clinical sites regionally from depots.
Provide site specific documentation as needed to depots and clinical sites to ensure on time and compliant delivery of CTM to clinical sites.

Requirements

BA/BS in Supply Chain, Engineering, or life sciences; certifications such as APICS, CPIM, CIRM, PMP are desirable.
10+ years’ experience in biotech/Pharmaceutical industry with 7+ years’ experience in Supply Chain.
Experience with CMC operations is desirable.
Demonstrated ability to establish supply chain strategy from clinical protocol.
Demonstrated knowledge of forecasting and inventory management, pooling supplies, drug product allocation, and IRT drug management modules.
Demonstrated experience in management of IRT systems.
Demonstrated experience in supporting global oncology trials with globally labelled CTM including packaging and over labeling commercial drug supply for combination trials.
Demonstrated skill in successful international shipment, including customs clearance.
Proven experience managing clinical drug supply for phase 1-3 global trials, Expanded Access Programs (EAP), and Investigator sponsored trials (IST).
Proven experience working with and managing external packaging and distribution partners.
Demonstrated ability in working with cross functional teams including Clinical Operations, QA, CRO, CMC, Regulatory, and Program Management.
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.
Ability to think strategically to anticipate risk to supply chain and develop mitigation strategy.
Having deep understanding of GMP/GDP/GCP, impact of regulatory timing on supply chain, global distribution and logistics.
Proficiency in MS Office Suite and IRT.
Experience with drug supply forecasting technology is strongly preferred.
All employees are expected to act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies, including IDEAYA’s Code of Conduct.
Employees must demonstrate good judgement and ethical behavior in all business activities, maintain patient and product safety as a top priority, and report any suspected violations of law or Company policy through appropriate channels.

Skills

Supply Chain
Clinical Trial Materials (CTM)
Clinical Supply Chain Management
Planning
Forecasting
Material Sourcing
Packaging
Labeling
Distribution
Return and Destruction of Investigational Drugs
Vendor Management
Depot Management
Contract Packaging Organizations (CPO)
CMC
QA
QC
Clinical Development/Operations
Regulatory Affairs
Program Management
Pharmacy Manuals
Investigator Meeting Materials
Site Initiation Visit Materials
Dosing Cards
Diaries
Trial Master File (TMF)
Inventory Management
Procurement
Temperature Excursions
Product Complaints
Expiry Date Extensions
Global Shipment Documentation
Proformas
Commercial Invoices
Batch Record Review
Label Text Preparation
Label Translation
Label Proofing
Regulatory Requirements
Clinical Study Supply Releases
QP Release
Certificates of Analysis/Compliance
Country Specific CTM Release
Re-labeling Operations
Retain Sample Management
Interactive Response Technology (IRT) Systems
IRT Specifications
IRT Requirements
IRT User Acceptance Testing (UAT)
IRT Inventory Monitoring
IRT Functionality Monitoring
IRT System Updates
IRT Resupply Generation
Import/Export Documentation
Customs Clearance
GMP
GDP
GCP
MS Office Suite
Drug Supply Forecasting Technology

Location

South San Francisco, CA

Work Type

Onsite (four days per week)

Experience Level

Associate Director
10+ years’ experience in biotech/Pharmaceutical industry
7+ years’ experience in Supply Chain

Education Level

BA/BS in Supply Chain, Engineering, or life sciences
APICS certification desirable
CPIM certification desirable
CIRM certification desirable
PMP certification desirable

Salary/Compensations

$167,000 - $206,000

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)

About the Company

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.
For more information, please see www.ideayabio.com.

Equal Opportunity

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.
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.
We are committed to providing reasonable accommodations to qualified individuals with disabilities.
If you need assistance or an accommodation due to a disability, please get in touch with us at hr@ideayabio.com.