Director, Clinical Systems

Position Overview

• Location Type: Remote
• Employment Type: Full-time
• Salary: Not specified

About Apogee Therapeutics: Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed biotechnology company founded in 2022. It is seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Apogee is committed to building an exceptional company culture based on its C.O.R.E. values: Caring, Original, Resilient and Egoless.

Role Summary

The Director of Clinical Systems will lead, deploy, and optimize multiple clinical systems within the Clinical Operations organization. This role will strategically evaluate business needs against clinical systems capabilities and partner in cross-functional collaboration with Information Technology (IT), internal stakeholders, external clinical system vendors and Clinical Research Organizations (CROs) to develop, manage and support the use of clinical systems including but not limited to Risk Based Monitoring (RBM), Interactive Response Technology (IRT), Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF), and Patient Reported Outcomes (ePRO/ eCOA). The position will also manage and assist with developing and implementing clinical system (business and technical) processes as they apply to SOPs, Work Instructions, tools, templates, and training. The position may be responsible for direct report(s) who manage clinical systems.

Key Responsibilities

• Lead Clinical Operations on system related initiatives and throughout a clinical system’s life cycle.
• Acts as primary business change agent to ensure adoption of new capabilities and business processes related to clinical systems and technology.
• Articulate global requirements, trial designs and business processes used across various therapeutic areas to support development of functional requirements for new or enhanced clinical systems.
• Develop and present to leadership business cases around clinical system related needs and technologies to support clinical trials sponsored by Apogee.
• Partner with CROs.

Requirements

• (No specific requirements listed in the provided text)

Application Instructions

• (No application instructions listed in the provided text)