Director, Head of Data Management

Clinical        ·       New York, NY       ·       Full time

Job Summary

We are seeking a highly creative and self-motivated Director, Head of Data Management with significant experience in drug development to work as a member of an integrated team translating Kallyope’s cutting-edge biology on the gut and gut-brain axis to transformational therapeutics.  As the in-house lead data management expert, the successful applicant will report to the Head of Biometrics and be responsible for the delivery, integrity, and quality of Kallyope clinical data across clinical studies that will translate Kallyope innovative science into impactful medicines for patients. Kallyope is based in New York City, but this role can also be remote in the United States, preferable in the East Coast time zone.

Key Responsibilities

• Oversee all data management activities, timelines, and deliverables for in house data management as well as outsourced services
• Provide technical and business expertise in support of data management deliverables
• Strategically streamline data management approaches across the development portfolio through adoption of technology, standards, and best practices
• Facilitate effective planning and execution of data management tasks for multiple programs including resourcing planning, timelines, and budgets
• Oversee consistency across programs to ensure data quality and integrity
• Collaborate with a dynamic Kallyope cross-functional team to ensure timeliness and quality of data deliverables
• Ensure compliance with global regulatory requirements and quality standards
• Grow and scale a strong data management team; develop data management personnel to advance leadership and project management skillset through training, mentorship, and coaching
• Oversee the development of trial case report forms as well as data collection parameters from various endpoint vendors in trials
• Provide necessary data listings program related deliverables where needed or requested (e.g., data safety monitoring board meetings, safety related reporting, dose escalation meetings)
• Support the implementation of processes and procedures that enable efficient data management procedures including risk-based monitoring, centralized data review, data cleaning metrics, and tracking
• Oversee and participate in user acceptance testing for electronic data capture systems and/or other data collection systems (e.g. IRT, ediary)
• Drive the planning, oversight, and execution of database lock procedures in collaboration with other development operations functions
• Ensure development of key data management related specification including but not limited to data management plans, edit specifications, annotated CRF or equivalent, manual data review guidelines, data transfer agreements, and endpoint related specifications
• Liaise with other biometrics and development team functions to ensure integrity of execution for data safety monitoring reviews, SDTM programming and pinnacle 21 activities, TLF dry run review, safety reporting, blinded/unblinded data review activities, interim analysis, and centralized data review activities
• Support SOP development for data management related activities as well as support the development of Kallyope operational infrastructure

Qualifications And Education Requirements

• B.A/B.S or MS in science/health-related field and at least 10 years of experience in the pharmaceutical/biotechnology industry as a Data Manager
• Advanced experience with data collection and cleaning covering Phase I, II, and III studies
• Experience in executing clinical studies across various phases is desirable
• Strong and current knowledge in global regulatory and compliance requirements including but not limited to US CFR, EU CTD, ICH GCP, and CDISC
• Experience in CRO and vendor oversight
• Motivated self-starter who is capable of flourishing in a fast-paced small company environment
• Creative problem-solver with excellent communication and public speaking skills      
• Strong interpersonal and organizational skills, with a high degree of attention to detail
• Pragmatic and able to manage multiple projects and needs effectively

About Kallyope:

Kallyope is a clinical-stage NYC-based biotechnology company focused on the gut-brain axis.  The company, founded in 2015 by Tom Maniatis, Richard Axel, and Charles Zuker, leverages leading technologies to map the hormonal and neural circuitry between the gut and other organs, including the brain, and translate new discoveries into novel therapeutics.  Our cross-disciplinary biotechnology team has built a platform integrating single cell and single nucleus sequencing, computational biology, neural imaging, cellular and molecular biology, and human genetics to provide an understanding of gut and gut-brain biology which, when coupled with our deep drug discovery expertise, will lead to therapeutics in multiple areas of high unmet need.  The Company has two lead programs in clinical development, one targeting metabolic circuits for diabetes and obesity, and the other focused on restoration of GI barrier function for IBD and other disorders associated with a defective barrier.   The company has raised $479 M in 4 rounds of funding from several leading biotech investors.  For more details, see https://kallyope.com. 

Please click here to apply.