Senior Director, Clinical Field Monitoring and Trial Operations

This is a fully remote position, open to applicants in Washington.

📋 Description

• Take charge of and advance Immunome’s clinical monitoring strategy, incorporating risk-based and purpose-built monitoring models.

• Establish standardized monitoring plans, key performance indicators, oversight activities, dashboards, templates, and best practices across trials and vendors.

• Design and execute the contract field monitoring team, focusing on staffing, sourcing, onboarding, and oversight.

• Direct monitoring oversight throughout the clinical portfolio, from site qualification to close-out.

• Identify and escalate site risks, protocol deviations, and data quality concerns; facilitate root-cause analysis and corrective and preventive actions (CAPAs).

• Build, guide, mentor, recruit, train, and retain high-performing teams.

• Conduct or supervise monitoring training and oversight visits.

• Collaborate cross-functionally to support study and vendor oversight, as well as inspection readiness.

• Oversee the selection, management, and supervision of contract field monitoring staffing partners and CRO vendors.

• Ensure vendor adherence to contractual obligations, timelines, quality standards, and performance metrics.

• Guarantee that monitoring and TMF activities align with ICH-GCP, FDA, EMA, and global regulatory requirements.

• Collaborate with Quality Assurance on inspection readiness, audit responses, and corrective actions.

• Align monitoring and TMF strategies, data flow, and technology across clinical functions.

• Represent Field Monitoring and TMF Oversight in governance meetings.

• Maintain financial oversight of monitoring budgets and contract scopes.

• Assist in developing and forecasting monitoring budgets.

• Oversee resource allocation across contract field monitoring and CTA teams.

⛳️ Requirements

• Bachelor’s degree with over 14 years of clinical monitoring experience in the biotechnology or pharmaceutical industry, or an equivalent combination of education and experience.

• Proven experience in resourcing, building, and managing Clinical Monitoring Teams and related infrastructure.

• Experience in developing standard operating procedures (SOPs), template reports, monitoring plans, and Clinical Trial Management Systems.

• Skilled in defining, executing, and supervising TMF quality-control activities.

• Willingness to travel up to 30% for in-house meetings and monitoring tasks.

• Comprehensive understanding of clinical development processes, trial design, global regulatory frameworks, and clinical monitoring methodologies.

• Expertise in ICH-GCP, FDA, and EMA regulations, source data verification, informed consent, and investigational product accountability.

• Strong operational insight and project management capabilities.

• Experience in implementing quality management and purpose-fit monitoring models and systems.

• Background in designing and establishing contract or FSP staffing models, including sourcing, onboarding, and performance management of contract CRAs.

• Knowledge of TMF structure, content, quality control, TMF Reference Model, essential document requirements, and TMF health metrics and KPIs.

• Ability to lead cross-functional initiatives and influence stakeholders at all organizational levels.

• Proficient in communication, negotiation, and relationship-building.

• Capability to build, lead, and mentor high-performing teams.

• Analytical and strategic problem-solving and decision-making skills utilizing monitoring data, KPIs, and dashboards.

• Capacity to manage multiple complex projects in a dynamic environment with professionalism, adaptability, and accountability.

🏝️ Benefits

• Equal opportunity employer dedicated to fostering diversity and an inclusive environment.

• Flexible remote work arrangement.

• Competitive salary range of $260,965–$309,341 USD for Washington State.