Senior Manager, Data Sciences

About Us

Dianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.

About the Role

This role is responsible for overseeing data-specific timelines and deliverables (both internal and external) from start-up through close out of various clinical trials. This includes coordination and timing for data transfers, internal and external data reviews, data deliverables for interim/final analyses, DSMB meetings and any other data-related deliverables.

You will report to the Director, Data Sciences and will independently support all active programs to ensure complete, accurate, high quality and regulatory compliant data in support of internal or external stakeholders, study reports, publications and regulatory submissions. This position requires both the knowledge and experience to work within established clinical trial paradigms while embracing new approaches to facilitate data aggregation and analysis in the advancement of patient care.

This is a unique opportunity to be part of a team driven by continuous innovation with very high scientific integrity and who hold our core principles at the center, with the goal to elevate the care of our patients’ lives. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

• Cultivate and manage relationships with DM partners (eg, CROs and other vendors) and cross functional team members to ensure data are reviewed and delivered with high quality, are on-time and within scope
• Accountable for ensuring timeliness of data deliverables are met and align with company goals
• Monitor and track data-related timelines and deliverables and serve as central point of communication for other cross-functional team members
• Document data workflows for assigned studies, ensuring transfers occur based on study-specific needs
• Support the development of standard operating procedures (SOPs) and processes with a focus on continuous improvement and increased efficiency
• Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing relevant data processes, documents, outputs and filing documentation in the trial master file (TMF).
• Other related duties as may be determined or assigned.

Experience

• University degree required within a relevant discipline. Life Sciences experience is a plus.
• Skilled in management of timelines and coordination with internal and resources to efficiently reach deliverables
• Comprehensive understanding of DM related systems and technologies
• Comprehensive knowledge of drug development and clinical research processes, GCP guidelines and regulations related to clinical data management
• Self-motivated and able to work autonomously, as well as a member of a high-functioning and collaborative team.
• Highly organized and detail-oriented.
• Strong verbal and written communication skills with an ability to build relationships internally and externally.
• Highest levels of professionalism, confidence, personal values and ethical standards.