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The Manager/Sr. Manager, Translational Medicine will report to the Director, Translational Medicine and will be responsible for leading key external vendor relationships, budgeting for external workstreams, and planning for new translational workflows within existing or new clinical programs. They will work closely with the operations team within the Translational group to support ongoing testing requests at external vendors. Additionally, they will assist in the authoring, data verification, and timeline management of early phase regulatory submissions.
Job Responsibility:
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
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
Working closely with subject matter experts within the Translational Medicine scientific team, facilitate technology transfer of key correlative assays from Cabaletta to external vendors
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
Requirements:
MS/PHD in a relevant field along with a minimum of 3+ years of relevant experience in the pharmaceutical or biotech industry or BS with a minimum of 5+ years of relevant experience
Strong understanding of drug development and clinical trial design, as well as experience in the interpretation and analysis of translational data
Prior hands-on experience with vendor management, contracting, legal discussions, and financial planning
A basic understanding of the regulatory process in the US and EU, is preferred
Excellent leadership, communication and interpersonal skills, and the ability to work effectively in a cross-functional team environment
Strong team orientation, collaborative skills, and passion for continuous self-development
Experience in industry or in a startup industrial setting is preferred
Background or relevant work experience in immunology or cell therapy is preferred
High level of flexibility to support various other activities the ability to learn new techniques outside of existing field of expertise is ideal