Director, Clinical Data Management

Position Overview :

The Director of Clinical Data Management will be responsible for the oversight of CDM activities outsourced to CROs, from study startup through study closeout. The individual would also be responsible for the development and implementation of clinical data management strategies and processes to enable the delivery of data capture, review and reporting systems that facilitate timely availability of actionable data to enable fast and efficient drug development. May have line management responsibilities.

Reporting Relationship : This person will report to the VP, Biometrics.

About Inozyme Pharma :

Inozyme Pharma is a pioneering clinical-stage biopharmaceutical company dedicated to developing innovative therapeutics for rare diseases that affect bone health and blood vessel function. We are experts in the PPi-Adenosine Pathway, where the ENPP1 enzyme generates inorganic pyrophosphate (PPi), which regulates mineralization, and adenosine, which controls intimal proliferation (the overgrowth of smooth muscle cells inside blood vessels). Disruptions in this pathway impact the levels of these molecules, leading to severe musculoskeletal, cardiovascular, and neurological conditions, including ENPP1 Deficiency, ABCC6 Deficiency, calciphylaxis, and ossification of the posterior longitudinal ligament (OPLL).

Our lead candidate, INZ-701, is an ENPP1 Fc fusion protein enzyme replacement therapy (ERT) designed to increase PPi and adenosine, enabling the potential treatment of multiple diseases caused by deficiencies in these molecules. It is currently in clinical development for the treatment of ENPP1 Deficiency, ABCC6 Deficiency, and calciphylaxis. By targeting the PPi-Adenosine Pathway, INZ-701 aims to correct pathological mineralization and intimal proliferation, addressing the significant morbidity and mortality in these devastating diseases.

Essential Duties and Responsibilities :

• Provide Clinical Data Management oversight of CRO and other external data vendors and ensure adherence to agreed project timelines and budgets.
• Provide leadership and expertise in data management ensuring data quality and regulatory compliance.
• Manage vendor relationships or partnerships from a Clinical Data Management perspective.
• Ensure the delivery of quality data by partnering with CROs and external vendors to develop and execute efficient quality data processes.
• Develop strategies for and implement ongoing improvements within Clinical Data Management to ensure the quality and integrity of the clinical data from Inozyme Clinical trials.
• Perform hands-on clinical data management study activities, including the development of case report forms (CRF).
• Determine the appropriate and effective use of data management information and system tools for data and report retrieval, data listing review, error detection, and production of standard displays to ensure quality data.
• Identify opportunities and implement solutions to globalize and standardize methods, processes, procedures, systems, and templates in accordance with CDISC / SDTM requirements and industry best practices.
• Develop, review, and implement Clinical Data Management processes, policies, and SOPs.
• Participate in technology provider and Clinical vendor qualifications and audits.
• Support study-level / program audit and inspection readiness activities as needed.
• Train and mentor members of the clinical trial team from other functions on processes, projects, systems, and programs.
• Lead data management support of submission activities.
• Maintain proficiency in Data Management systems and processes through regular training and / or attendance at professional meetings / conferences.
• Line-Management responsibilities, if required.

Educational Qualifications :

Additional Qualifications :

J-18808-Ljbffr