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- Owns end-to end clinical supply chain responsibilities, including but not limited to, study design and operation input regarding supply, multi-stage (i.e., from raw materials through finished goods) demand and supply planning, inventory management and distribution.
- Develops strategies to ensure robust clinical supply throughout clinical trial duration in collaboration with Clinical Operations, Manufacturing, Packaging, Quality Assurance, Regulatory, and Project Management.
- Manages supply for dynamic international clinical studies spanning the lifecycle of programs; Phase 1, 2, 3 and post-approval.
- Develops and manages lot use strategies with CMC functions and Clinical Operations; ensuring CMC changes are approved as needed to enable lot use in the targeted countries.
- Manages expiry and remaining shelf-life requirements to meet country, site and patient requirements and minimize obsolescence.
- Participates in the Demand & Operations Planning (D&OP) process, including presenting in the D&OP meeting, participation in pre-D&OP supporting meetings, compiling, and validating data, generating supply plans and reports/dashboards, and creation of meeting content.
- Generates production forecasts for contract organizations, liaise with Contract Organization (CO) business owners to ensure schedules meet plan objectives and adhere to CO requirements.
- Supply Chain lead on designated clinical product CMC teams, creating strong communication between Supply Chain and the CMC team.
- Identifies gaps in the plan to meet target study timelines and inventories, develops new feasible plans to mitigate current and future risks.
- Executes consistent supply plans and associated metrics across product lines and compliance with Ultragenyx policies, procedures and applicable regulatory authority directives and regulations and contract terms.
- Coordinates and provides oversight of distribution of Investigational Medicinal Products (IMP) to depots and sites, as well as import and export of GMP materials.
- Partners with internal stakeholders to ensure that goals are met for inventory levels, tracking, storage, as well as distribution activities.
- Provides oversight of drug depot service, transportation logistics, and management of obsolete or expired inventory.
- Reviews and prepares departmental SOPs and ensures compliance with industry standards.
- Ensures compliance with Good Manufacturing Practices (GMP) and applicable state and federal regulatory requirements.
- Superuser for the advanced planning system launched in 2022 (Kinaxis). Requires SME level knowledge of system capabilities, process, and ability to troubleshoot basic issues. Owns clinical product master data, including planning attributes requiring understanding impact of attributes to the supply plans.
- Utilize systems to load clinical supply forecasts, run plans and scenarios, manage planned orders (e.g., production and transfers).
- Actively participates in IRT/IXRS setup, testing and execution.
- Uses Quality Management System (Veeva) to initiate and assess clinical supply impacting quality events, e.g., change controls, deviations and CAPAs.
- Responsible for preparation and management of contracts/SOWs/purchase orders with CMOs for storage and distribution and other related clinical supply activities.
- Supports Finance via tracking of PO expenditure and monthly accruals for the clinical supply work.
- Participates in the departmental budgeting process - forecasts, storage, and distribution expenses, approves invoices.
- Directs projects, including acting as project team lead, for activities related to clinical product supply.
- Accountable and responsible for clinical inventory reconciliation and destruction at depots.
- Compares supply plans to accepted budgets and escalate foreseeable financial variances.
- Bachelor's degree in Biotechnology, Supply Chain, Engineering or related STEM discipline, Masters desired.
- Minimum of 5 years of experience in biotech / pharmaceutical industry
- Experience with Kinaxis, SmartSheet, PowerBI or similar systems
- In-depth understanding of CMC, GMPs, quality, clinical operations, and blinding practices, and IRT/IWRS systems
- Working knowledge of cGXP's and pharmaceutical industry procedures and regulations
- Working knowledge of import and export requirements in a regulated environment
- Experience participating in cross functional teams such as CMC/Clinical teams
- Experience interfacing with internal operations groups and/or contract manufacturing organizations on early and late phase clinical trials
- Independent, self-motivated individual with the ability to manage change through influence
- Ability to solicit input, obtain stakeholder buy-in and build cross-functional consensus
- Experience in building new processes and establishing standards
- Demonstrated ability for analytical and systematic thinking. Strong problem-solving and decision-making skills
- Strong interpersonal skills and works effectively as part of a team
- Exceptional verbal and written communication skills
- Ability to lead mid-size projects through the change management process and the use of project management tools
- Travel: approximately 10% #LI-CS1 #LI-Hybrid
associate director, clinical supply gene therapy - Novato, CA , USA, United States - Ultragenyx Pharmaceuticals Inc.
Description
Position Summary:
ultrafocused - Work together to fearlessly uncover new possibilities
Reporting to the Head of Global Planning, Ultragenyx is seeking a highly motivated Associate Director, Clinical Supply Gene Therapy with expertise in end-to-end pharmaceutical clinical supply strategies and operations.
In this position you will be responsible for development, management and execution of demand and supply plans for 2-3 clinical programs, and all associated studies.
In this role you will collaborate with Clinical Operations, Manufacturing, Packaging and Labeling, Regulatory, Quality and Program Management to supply clinical sites internationally.
Work Model:
Flex:
This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.
Responsibilities:
Process
Requirements: