Manager/Sr. Manager, Translational Medicine

Cabaletta Bio Inc

Philadelphia, PA

JOB DETAILS
SKILLS
Alliance/Partner Management, Assay Development, Assays, Clinical Practices/Protocols, Clinical Support, Clinical Trial, Conferences, Contract Management, Cross-Functional, Data Processing, Drug Development, Maintain Compliance, Medicine, Quality Assurance, Regulations, Regulatory Submissions, Scientific Publications, Supplier Relationship Management (SRM), Time Management, Vendor/Supplier Management, Vendor/Supplier Planning, Vendor/Supplier Relations, Vendor/Supplier Selection
LOCATION
Philadelphia, PA
POSTED
30+ days ago

Responsibilities: Responsibilities: Lead new vendor selection and manage ongoing vendor relationships necessary to support early phase and registrational clinical trials in the United States and within ex-US countries. Align heavily with Clinical Operations, Clinical Development, Regulatory Affairs and Quality Assurance on these partnerships. Establish new and manage existing vendor contracts and alliance to drive development of ongoing and future trials. Identify and vet novel translational vendors to support assay transfer and manage bespoke assay development. Manage translational vendor relations and strategy across US and ex-US sites to ensure compliance and consistency across regulatory and quality. Support bespoke and annual regulatory submissions supporting early Phase clinical programs within the US and ex-US. Where necessary, support new clinical trial protocol development alongside the Clinical Development and Regulatory teams at Cabaletta. Working closely with subject matter experts within the Translational Medicine scientific team, facilitate technology transfer of key correlative assays from Cabaletta to external vendors. Oversee timelines and execution of assay validation, data generation, data transfer processes, and data interpretation. Collaborate with cross-functional clinical operation study teams to ensure the successful execution of clinical studies and the timely delivery of high-quality study results. Attend scientific conferences, meetings, and workshops to keep up to date with the latest developments in the field of translational medicine, vendor management and contribute to scientific publications. Qualifications:

About the Company

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Cabaletta Bio Inc