Senior Director, Clinical Field Monitoring and Trial Operations

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🔥 0 minutes ago

☕ Washington – Remote

☕ Washington – Remote

💵 $261k - $309.3k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Immunome, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

Healthcare • Biotechnology • Healthcare Insurance

Immunome, Inc. is a clinical-stage oncology company dedicated to improving outcomes for cancer patients through the development of innovative therapeutic candidates. With a focus on targeted therapies, Immunome integrates rigorous scientific research to create first-in-class and best-in-class treatments. Their pipeline includes several promising drug candidates, including antibody drug conjugates and radioligand therapies aimed at addressing high unmet medical needs in oncology.

📋 Description

• Own and evolve Immunome’s clinical monitoring strategy, including risk-based and fit-for-purpose monitoring models • Standardize monitoring plans, KPIs, oversight activities, dashboards, templates, and best practices across trials and vendors • Design and implement the contract field monitoring team, including staffing, sourcing, onboarding, and oversight • Lead monitoring oversight across the clinical portfolio from site qualification through close-out • Identify and escalate site risks, protocol deviations, and data quality issues; drive root-cause analysis and CAPAs • Build, lead, mentor, recruit, train, and retain high-performing teams • Conduct or oversee monitoring training and oversight visits • Partner cross-functionally to support study and vendor oversight and inspection readiness • Lead selection, management, and oversight of contract field monitoring staffing partners and CRO vendors • Ensure vendor compliance with contractual obligations, timelines, quality standards, and performance metrics • Ensure monitoring and TMF activities comply with ICH-GCP, FDA, EMA, and global regulatory requirements • Partner with Quality Assurance on inspection readiness, audit response, and corrective actions • Align monitoring and TMF strategy, data flow, and technology across clinical functions • Represent Field Monitoring and TMF Oversight in governance meetings • Maintain financial oversight of monitoring budgets and contract scope • Support monitoring budget development and forecasting • Oversee resource allocation across contract field monitoring and CTA teams

🎯 Requirements

• Bachelor’s degree with 14+ years of clinical monitoring experience in the biotechnology or pharmaceutical industry, or equivalent combination of degree and years of experience • Experience resourcing, building, and managing Clinical Monitoring Teams and related infrastructure • Experience developing SOPs, template reports, monitoring plans, and Clinical Trial Management Systems • Experience defining, performing, and overseeing TMF quality-control activities • Ability to travel up to 30% for in-house meetings and monitoring activities • Deep 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 acumen and project management skills • Experience implementing quality management and fit-for-purpose monitoring models and systems • Experience 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 • Ability to communicate, negotiate, and build relationships effectively • Ability to build, lead, and mentor high-performing teams • Analytical and strategic problem-solving and decision-making skills using monitoring data, KPIs, and dashboards • Ability to manage multiple complex projects in a dynamic environment with professionalism, adaptability, and accountability

🏖️ Benefits

• Equal opportunity employer committed to diversity and an inclusive environment • Remote work arrangement • Salary range of $260,965–$309,341 USD for Washington State