Director, Site Engagement & Monitoring Excellence (CONTRACT)

Eikon Therapeutics•Jersey City, NJ

7d•Hybrid

About The Position

The Director, Site Engagement & Monitoring Excellence (Contract) will lead the development and execution of Eikon’s global trial site engagement strategy and oversee internal and externally managed site-monitoring activities. The role is accountable for predictable delivery of high-quality data and for building Eikon’s reputation as a preferred sponsor among clinical sites. The Director will collaborate with clinical study teams and Functional Service Provider (FSP) partners to advance site relationship management and monitoring across Eikon’s clinical programs. The position requires onsite presence at least three days per week, or more as business needs require, at either the California or New Jersey offices. The Director will guide and manage the site engagement team, including CRA site monitors and outsourced providers; establish performance standards and harmonized processes; oversee resources, talent, budgets, vendors, training, and monitoring quality; and ensure compliance with ICH GCP and applicable regulatory, quality, and timeline objectives. The role also uses site intelligence, metrics, site-health information, and risk-based monitoring signals to identify risks, improve quality, and accelerate study delivery. The Director serves as an escalation point for site-engagement issues, works across Clinical Operations and Clinical Development, contributes to department infrastructure and process development, and develops and retains team talent. Travel of up to 25% is expected. The role is offered at an expected hourly rate of $100.50 to $121.00, depending on skills, competency, and market demand.

Requirements

Postgraduate degree and at least 10 years of relevant experience, or a bachelor’s degree and at least 12 years of relevant experience.
Relevant field such as life sciences, nursing, or a related discipline.
Significant management experience in an oncology clinical-trial setting.
Ability to collaborate effectively with Clinical R&D stakeholders in a matrix organization.
Management expertise covering budgets, resources, headcount, processes and controls, productivity, quality, and project delivery.
Complete understanding of ICH GCP and global and regional regulatory requirements.
Strong written and spoken English communication skills.
Strategic thinking and high emotional intelligence.
Strong leadership skills to attract, motivate, inspire, develop, and retain talented staff and align them with company goals and mission.
Ability to work onsite at least three days per week at either the California or New Jersey office, with additional onsite presence as business needs require.
Ability to travel up to 25%.

Nice To Haves

Skills in more than one language.

Responsibilities

Define and implement site engagement strategies to improve relationships with clinical sites.
Support the development of new site partnerships and networks.
Support high-quality monitoring approaches aligned with regulatory standards.
Serve as a liaison between clinical study teams and investigative sites.
Guide, oversee, and train the study site engagement team, including internal and outsourced CRA site monitors.
Develop and maintain performance standards, processes, and documentation for harmonized site engagement and monitoring across clinical programs.
Maintain information exchange within the site engagement team; identify common support needs and lessons learned across regions and countries; troubleshoot issues; and distribute site intelligence to Clinical Operations and Clinical Development stakeholders.
Oversee resource and talent management for the site engagement team and CRA monitors across regional and country clusters.
Oversee and train FSPs, site engagement staff, and CRAs by country and region, and identify and manage CRA performance issues.
Ensure corrective and preventative actions are implemented and that ICH GCP compliance and regulatory, quality, and timeline objectives are met across global trials.
Monitor site and monitoring quality using interpretive signals and local country intelligence to identify risks proactively.
Lead site- and country-level risk assessments for designated studies and identify mitigation and control measures.
Use appropriate tools and resources, including metrics, site health, and risk-based monitoring signals, to improve quality and accelerate study delivery.
Track site engagement metrics and satisfaction scores.
Share site quality trends and preventative actions across studies and clinical programs to support accelerated drug delivery.
Act as the escalation point for site engagement issues, escalating as needed and informing relevant Clinical Operations study teams of escalation and resolution.
Solve problems and exercise judgment concerning national and international regulations, guidelines, investigator interactions, and timelines.
Manage the functional budget, resource projections, capacity assessment, and vendor oversight and evaluation to ensure appropriate resourcing for the clinical trial portfolio.
Align with global Clinical Development stakeholders on strategies and approaches that meet program and study goals and incorporate the site engagement team’s input.
Contribute to department infrastructure development, including SOP development and implementation, new processes, and clinical system capabilities.
Collaborate with Clinical Development leadership on important projects and apply relevant industry trends and innovations to site engagement practices.
Develop, coach, and retain team talent; set clear performance standards and hold self and the organization accountable for results.
Use metrics and key performance indicators to guide performance.