Director, Clinical Systems

 

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics, Inc. is a biotechnology company 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. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.  If this sounds like you, keep reading!

 

Role Summary

We are seeking a Director of Clinical Systems as the strategic leader leading, deploying and optimizing of multiple clinical systems within the Clinical Operations organization. This position will strategically evaluate business needs against clinical systems capabilities and partner in cross-functional collaboration activities 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). Additionally, this position will 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 cross-functionally to define standard operational terminology and data conventions used for clinical systems.
• Work with business process and system owners to define user roles, permissions, and training requirements.
• Serve as the business process owner for some clinical operations systems as required.
• Oversees and supports activities related to system builds, integrations and implementation, as needed (e.g., writing and/or executing UAT scripts)
• Partner with cross-functional team members (e.g., Biometrics, Tech Ops/Clin Supplies, QA, IT, Procurement) to identify and select clinical system vendors, and ensure effective onboarding and implementation (e.g., qualification, Computer System Validation (CSV), system specifications, UAT).
• Participate in contracting and budget management activities including establishing an initial Scope of Work (SOW) and Change Orders, as applicable
• Supports/oversees kickoff meeting(s) for each respective trial with the system/technology supplier and internal cross-functional team members
• Ensures completion of system deliverables within established timelines including but not limited to CSV requirements and vendor qualification.
• Provide oversight of the system vendors, monitoring and addressing gaps in both quality and timeliness of their work
• Lead and manage resolution of issues and remediation activities with stakeholders and the clinical system vendor
• Identify root cause of performance issues, determine the appropriate remediation, and implement solutions, as required.
• Identifies areas of opportunity, mitigates risks, and provides solutions to identified problems.
• Serves as an escalation point for study teams to drive resolution of issues, as appropriate.
• Lead and collaborate in developing solutions and measuring their effectiveness.
• Evaluate evolving i