Immunome, Inc.
Director, Clinical Site and Trial Operations
Bothell, Washington, United States · Director
Sponsorship not specifiedDetected 20 days ago
GCPComplianceVendor ManagementClinical TrialsFDA RegulatoryLeadershipCollaborationRegulatory Affairs
About the role
- Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug
- conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been submitted to the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-3050, an IND-cleared FAP-targeted radiotherapy; and IM-1617, an IND-cleared solid tumor ADC. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed
Responsibilities
- Lead site management and trial operations across Immunome's oncology portfolio from planning through completion, ensuring studies meet timelines, budgets, and quality standards.
- Build, lead, and mentor a high-performing CSTO team.
- Support long-term resource planning and department growth for a rapidly expanding clinical portfolio.
- Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies.
- The Director will lead and develop a high-performing CSTO team, partner closely with Clinical Project Delivery on trial delivery, oversee day-to-day vendor management, and establish site-facing best practices to ensure operational excellence.
- The Director may also lead one or more outsourced trials and/or lead US site management and trial operations activities on mixed model studies where US site management and monitoring is conducted in-house, and ex-US is outsourced.
Benefits
- Establish a strategic vision for the function and implement operational best practices and SOPs in collaboration with cross-functional teams.
- The Director will collaborate with cross-functional stakeholders, including Clinical Development, Regulatory Affairs, Medical Affairs, CMC, and Quality, to ensure the successful execution of Immunome's clinical trials.
Company info
- We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates.
- We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.
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