Description:
Job Title: Director / Sr. Director Clinical Supply Operations
Company: Immunome, Inc.
Location: Bothell
About Us:
Immunome is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies. Our portfolio pursues each target with a modality appropriate to its biology, including immunotherapies, targeted effectors, radioligand therapies and antibody drug conjugates (ADCs). We believe that pursuing underexplored targets with appropriate drug modalities leads to transformative therapies. Our proprietary memory B cell hybridoma technology allows for the rapid screening and functional characterization of novel antibodies and targets.
Position Summary:
The Director / Sr. Director is responsible for developing and leading the Clinical Supply Operations function at Immunome, Inc. This is a visible role responsible for ensuring robust planning, compliant operations, and delivering uninterrupted supply of clinical trial materials across the development portfolio.
Key Responsibilities:
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Team Management: Hire and develop a high-performance team of supply operations professionals. Maintain a positive and inclusive environment where staff are motivated, empowered, and challenged. Build the Clinical Supply Operations function with a compliance mindset, ensuring robust processes and procedures are developed, maintained, and improved.
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Function Development: Design, develop, and implement Clinical Supply Operations business processes and cGMP procedures, encompassing but not limited to label copy creation and approval, labeling and packaging operations, comparator and co-medication sourcing, clinical product return and reconciliation, and clinical product destruction. Ensure processes are validated where appropriate. With a continuous improvement mindset seek opportunities for enhancement; evolve processes and infrastructure to better ensure compliance, efficiency, and cost optimization.
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Production Planning and Operations Work with the cross-functional CMC teams to ensure clinical supply operations are integrated properly into the program timelines. Lead and oversee the successful execution of clinical labeling and packaging operations. Partner closely with Quality to ensure efficient documentation reviews pre- and post-production. Ensure Quality systems work, including training, change controls, corrective and preventative actions, and investigations, are managed to the highest standards.
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Contracts & Supplier Relationship Management: Own contracting and business relationship management for external suppliers. Will serve as the primary business contact and relationship manager as the function develops. Ensure relationships are maintained in a state of good health. Develop and implement robust metrics and KPIs to measure performance. Ensure supplier performance is routinely reviewed via formal business review meetings and periodic executive steering committee meetings.
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Systems & Processes: Develop and implement customized clinical supply management tools for use in day-to-day operations and planning. Assess and implement more advanced supply chain information systems to improve efficiency and the capability to quickly analyze data. Support the design and implementation of enterprise-level systems such as Oracle or SAP.
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Financial: Partner closely with department leadership and Finance to develop budgets and performance targets. Ensure spending is accurately tracked and variances are communicated proactively.
Other Responsibilities and Projects:
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Develop close partnership with Clinical Development Operations to understand study plans as they evolve. Advise the clinical study teams on the optimal supply strategy, associated timelines, and risks.
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Ensure function-level planning meetings are held consistently and that program assumptions (demand and supply) are well understood and documented.
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May lead Sr. Management-level supply review meetings, presenting clinical demand forecasts, production plans, inventory projects, supply risks and mitigations (e.g., clinical S&OP meetings). Lead risk mitigation strategy discussions and scenario development.
Requirements:
Education and Experience:
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Bachelor’s or advanced degree in Supply Chain Management, Biotechnology, or related field. APICS or ISM certification is preferred.
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Minimum of 12 years of industry experience in clinical and/or commercial supply chain roles.
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Minimum of 8 years of supervisory experience.
Other Qualifications:
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Strong leadership skills and proven success in building and leading teams with a positive, can-do management style.
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In-depth knowledge of clinical supply chain management practices for pharmaceutical and biopharmaceutical products. Direct experience with both sterile injectables and solid oral dosage products is preferred. Direct experience with highly potent products is preferred.
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Thorough understanding of regulations applying to supply chain activities, including cGMP, GCP, and computer systems/Part11 compliance.
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Demonstrated success in effectively overseeing third party suppliers, and a skilled contract negotiator.
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Excellent cross-functional collaboration and communication skills.
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Comfort with ambiguity and uncertainty; adapts swiftly and leads others through complex situations.
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Position will require domestic and international travel (up to 20%) and occasional evening and/or weekend commitment.
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Salary range
$202,000 - $266,000