Manager or Sr. Manager of Translational Medicine

About the role

The Manager or 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.

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 alliances 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.
• Work 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

• 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.
• A 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.
• A strong team orientation, collaborative skills, and passion for continuous self-development.
• Experience in industry or in a startup industrial setting is preferred.
• A background or relevant work experience in immunology or cell therapy is preferred.
• A high level of flexibility to support various other activities the ability to learn new techniques outside of existing field of expertise is ideal.
• A highly motivated self-starter.