Director, Clinical Systems

Summary

Join Apogee Therapeutics as their Director of Clinical Systems, a strategic leadership role focused on deploying and optimizing multiple clinical systems within the Clinical Operations organization. You will evaluate business needs, collaborate with IT and external vendors, and manage the lifecycle of systems like RBM, IRT, CTMS, and eTMF. This position requires managing direct reports, developing processes, and ensuring compliance. The ideal candidate possesses extensive experience in clinical systems management, including Veeva, IxRS/IRT, CTMS, and ePRO/eCOA. A competitive salary and benefits package are offered, including flexible PTO and company-wide shutdowns.

Requirements

• Bachelor’s degree required
• Minimum of 15 years of experience working in or partnering with a Clinical Operations Organization
• Minimum of 10 years of experience in clinical systems related management including: Veeva systems implementation and management
• IxRS/IRT and related systems
• CTMS and related systems
• Minimum of 5 years of experience with ePro/eCOA experience
• Demonstrated familiarity and use of the System Design Life Cycle (SDLC)
• Successful record in leading the implementation of clinical systems
• Working knowledge of Good Clinical Practices and Health Authority regulations governing clinical trial execution
• Detail-oriented and able to manage many projects simultaneously
• Experience with documentation in a regulated environment
• Meeting management, facilitation, and negotiation skills
• Extensive vendor management experience
• Excellent project management and organizational skills, attention to detail and follow through
• Sound problem resolution, judgment, and decision-making abilities
• Highly organized with a strong attention to detail, clarity, accuracy, and conciseness
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Self-direction, motivation, problem solving and decision-making abilities
• Demonstrated effective written and verbal communication skills with internal and external team members, and functional leadership
• Able to navigate complex problems, develop advanced concepts, make decisions, anticipate challenges, and propose solutions/recommendations

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 industry trends and best practices and assess their impact on current processes
• Ensure compliance with applicable SOP’s
• Responsible for executing audit trail reviews of the clinical systems and additional compliance related activities, as required
• Develop standard reports and metrics for system users and internal stakeholders and clinical system vendors
• Provides functional and technical support and expertise for audits and inspections with respect to the clinical systems
• Collaborate with the vendor on on-going system issues, upgrades, and maintenance

Preferred Qualifications

Position requires travel up to 3-4 times per quarter, based on business needs

Benefits

• A great culture, grounded in our C.O.R.E. values: C aring, O riginal, R esilient and E goless
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Flexible PTO
• Two, one-week company-wide shutdowns each year
• Commitment to growing you professionally and providing access to resources to further your development
• Apogee offers regular all team, in-person meetings to build relationships and problem solve