Director/Senior Director, Clinical Supply Manager

South San Francisco, United States /
Chemistry – CMC /
Full Time
IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. Our approach integrates extensive capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the therapies we are developing. We are applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and synthetic lethality – which represents an emerging class of precision medicine targets. We believe this diversified approach will enable us to deliver the right medicine to the right patient to drive a more robust clinical response.
 
IDEAYA has an industry leading platform and pipeline in Synthetic Lethality. IDEAYA has established strategic collaborations with Amgen and Pfizer supporting its pipeline programs, and also has wholly-owned or controlled clinical and preclinical programs. For more information, please see www.ideayabio.com.

Position Summary:
We are seeking an experienced and highly motivated Director/Senior Director, Clinical Supply Manager who will report to the VP of CMC. This individual will be responsible for timely provision of clinical trial material (CTM) for all clinical trials of Ideaya programs, manage outsourcing to external vendors and Contract Manufacturing Organizations (CMOs) to ensure labeling, packaging and shipping of CTM in compliance with applicable regulations. This requires close coordination across multiple functional areas with-in Ideaya, e.g., Pharmaceutical Development, QA, QC, Clinical, Regulatory, CMC, etc. The successful candidate will be responsible for but not limited to those activities listed below.

What you'll do:

    • Clinical Trial Supply Management (General):
    • Interpret and advise on clinical trial protocols for study supply requirements/challenges 
    • 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 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
    • Manage supply planning/forecasting to ensure alignment with study activity and timelines 
    • Monitor inventory levels at sites and depots through the life of a trial taking preventative actions to avoid potential supply issues; management may be manual or automated depending on study systems utilized
    • Establish and document supply chain for each project as applicable to scope 
    • Coordinate procurement of any required commercially sourced supplies
    • Follow-up on reported 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 generated by Clinical Operations
    • Provide and/or support documentation for global shipment of clinical supplies, e.g., proformas and commercial invoice
    • 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 primary point of contact for third party packaging, distribution, and storage Vendors 
    • Provide details for and /or review of Request for Proposals, Scopes of Work, Service Agreements, Contracts, etc. 
    • Approve the packaging and logistics service agreements
    • Provide input, review, and approval of Vendor study specifications/plans
    • Review and approve vendor invoices against contract and identify out-of-scope activities

    • 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 scheduling and production of labels and primary/secondary 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.)
    • Coordinate expiry date extensions and re-labeling operations, when applicable
    • Manage maintenance of appropriate quantity of retain samples 

    • IRT (Interactive Response Technology) Systems
    • Work with cross-functional team 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 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 an escalation point for supply related issues received from sites 

Requirements:

    • Bachelor’s Degree or higher in health or life sciences  
    • 7+ years’ experience in the pharmaceutical/ biotechnology industry performing international clinical supply logistics/management 
    • Experience interpreting clinical study protocols and developing well-planned, accurately forecasted clinical supply plans/forecasts
    • Thorough knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines and other applicable global pharmaceutical regulations/guidelines/directives
    • Experience with Interactive Voice/Web Response System (IRT) design, implementation, user testing and monitoring
    • Proficiency in Microsoft applications (Word, Excel, PowerPoint, Outlook, etc.), and Collaborative platforms (e.g., SharePoint, eRooms, Drop Box, Skype for Business), Electronic Data Capture systems, and Inventory Management systems
    • Willingness and ability to travel domestically and internationally as needed
    • Demonstrated leadership capabilities, effective organizational skills, and excellent verbal and written communication; ability to present in large and group settings
    • 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. 
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company’s facilities, with partial 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.

Benefits
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.

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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