Manager, Biomarker Operations

Job Description Who we are looking for. Cellectis is looking for a Manager of Biomarker Operations to join our team. The successful candidate will be responsible for coordinating all aspects of biomarker operations activities, guiding site coordinators on central laboratory collections, and managing analytical vendors. As a key contributor to the clinical biomarker strategy, the individual will be accountable for implementation and execution of clinical sample collection, testing and data delivery activities for early phase clinical programs in oncology. The Manager, Biomarker Operations will work closely with cross-functional teams, including Clinical Operations, Data Management, and Translational Scientist, to ensure successful delivery of biomarker data to support clinical trials. The successful candidate will have experience bridging both science and operations though cross functional partnerships, strategic project planning and facilitating key biomarker execution discussions. Title Manager, Biomarker Operations Reports to VP, Translational Sciences Location New York, NY Purpose and Responsibilities The successful candidate will (Responsibilities include, but are not limited to): Develop and maintain effective, collaborative relationships with Clinical Study Teams, Clinical Sites, CROs, and other key stakeholders to ensure biomarker samples are, processed, tested and data is reported to meet development timelines and specifications Establish study-specific biomarker analysis and data management plan Manage the execution of biosample analysis logistics and timelines, from sample collection and processing, shipment, testing, data transfer, and final sample disposition, in accordance to study protocol and under the highest standards of quality, ethics, and informed consent Proactively identify, resolve, and facilitate resolution of sample and data discrepancies. Provide biosample metrics and status updates to teams as requested. Contribute to Central Lab setup and management throughout the course of a study Collaborate on the development and finalization of the Biomarker Management Plan based on input from Translational and Clinical Operational teams Contribute to the preparation of clinical documents such as lab manuals, informed consent forms, sample management plan, early development plans and site training materials Develop and maintain biomarker data standards and processes to ensure consistency across clinical trials Education and Experience: PhD with 2+ years project management, oncology and/or clinical trial experience or Master's Degree with 3+ years project management, oncology and/or clinical trial experience or Bachelor's Degree with 7+ years of project management, oncology and/or clinical trial experience Demonstrated technical experience/knowledge of bioanalytical assay methods related to cancer immunotherapy, T cell engagers, and antibody-based therapeutics is preferred. Experience with clinical study operations teams and understanding of clinical drug development strategic planning of clinical research; working knowledge of ICF, ICH GCP, GLP, regulatory compliance and FDA standards. Proven ability to efficiently and effectively manage multiple competing priorities and deliver results successfully. Proven success leading teams, working collaboratively in a cross-functional environment, and motivating team members to drive toward success Final level based on qualifications and experience Role is based in New York and hybrid (4 days/week in office) Technical Skills / Core Competencies: Is a team player who is able to participate in collaborative, cross-functional projects while being adept in working efficiently as an individual Strong analytical and problem-solving skills Excellent communication and interpersonal skills Strong project management and organizational skills Excellent troubleshooting and multi-tasking skills, attention to detail Ability to effectively and collaboratively work on global cross-functional teams Comfortable operating in a fast-paced environment and able to multi-task and adjust workload based upon changing priorities Physical Requirements Sedentary - primarily involves sitting and/or standing. Communicates with others on a daily basis to exchange information. 4 days per week onsite required

Created: 2024-11-05