Associate Director, Clinical Supply Chain

IDEAYA Biosciences•South San Francisco, CA

7d•$167,000 - $206,000•Hybrid

About The Position

IDEAYA is seeking an Associate Director of Clinical Supply Chain. The role of Associate Director is responsible for providing execution support for all aspects of clinical trial materials (CTM) for all clinical trials of IDEAYA programs. This position will provide support to the leadership of Clinical Supply Chain in the planning, forecasting, material sourcing, packaging and labeling, distribution, return and destruction of IDEAYA investigational drugs. The essential responsibilities of Associate Director include (but not limited to) clinical trial supply management, vendor management, oversight of external partners including depots and Contract packaging Organizations to ensure robust and compliant supply chain for all IDEAYA’s programs and in accordance with applicable laws and regulations. This role requires close coordination and collaboration with stakeholders across multiple functional areas within IDEAYA including CMC, QA, QC, Clin Dev/Clin Ops, Regulatory, and Program Management. This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy. Reporting to: Director, Clinical Supply Chain

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.

Nice To Haves

certifications such as APICS, CPIM, CIRM, PMP are desirable.
Experience with CMC operations is desirable.
Experience with drug supply forecasting technology is strongly preferred.

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 (i.e., Investigator Meeting and Site Initiation Visit slides, Dosing Cards, Diaries, etc.) 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; management may be manual or automated depending on study phase and complexity
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 (e.g., QP Release, Certificates of Analysis/Compliance, Country specific CTM release)
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