Senior Director, Site Engagement and Monitoring Excellence

Eikon Therapeutics • Jersey City, NJ

1d

About The Position

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
Position
The Senior Director, Site Engagement and Monitoring Excellence provides strategic and tactical operational leadership, ensures quality, consistency, and excellence in clinical monitoring across all programs. The role leads internal regional monitoring teams and Functional Service Provider (FSP) partners to deliver inspection‑ready data in compliance with ICH‑GCP, regulatory requirements, and Eikon objectives.

Requirements

• Post Graduate degree with 15+ years of experience or a Bachelor’s degree with 18+ years of experience in a relevant field, such as Life Sciences, Nursing, or a related discipline.
• Significant management experience in oncology clinical trial setting with the ability to effectively collaborate with different Clinical R&D stakeholders in a matrix organization. Management expertise should cover management of budget, resources, headcount, processes (and controls), productivity, quality and project delivery.
• A complete understanding of ICH GCP and global/regional regulatory requirements is required.
• Strong communication skills requiring proficiency in written and spoken English. The incumbent must be competent and effective in written and verbal communication. Skills in more than one language are an advantage in this role.
• Strategic thinking and high emotional intelligence.
• Strong leadership that will attract, motivate, inspire, develop and retain talented staff. In addition, leadership skills that enable and drive alignment with the goals, purpose and mission of our company.

Responsibilities

• Develop guidance, oversight and training to the site engagement team, including site monitors, whether insourced or outsourced suppliers, to maximize effectiveness and acceleration in Company’s operational execution of clinical research.
• Lead and mentor internal monitoring teams, fostering a culture of quality, compliance, and accountability.
• Oversee the development, review, and maintenance of Monitoring Plans, Oversight Plans, SOPs, Work Instructions, Best Practices and Palybooks
• Develop and maintain appropriate performance standards, processes and documentation for harmonized site engagement and monitoring support across Company’s clinical programs.
• Maintain regular information exchange within the study site engagement team, identify common elements of study support across regions/countries to codify and apply lessons learned, troubleshoot issues and distribute acquired site intelligence to Clinical Operations study teams and Clinical Development stakeholders as required.
• Oversee resource and talent management of site engagement team, including CRA monitors, whether insourced or via outsourced suppliers, across relevant regional/country clusters to maintain quality of monitoring that deliver and achieve Clinical Operations study team goals.
• Accountable for overall oversight and training of FSP, study site engagement and CRAs by country/region. Responsible for ensuring associated corrective and preventative actions are put in place, and that ICH GCP compliance, regulatory, quality and timeline objectives are met for all trials executed globally. Engage with FSP partners to ensure high-quality monitoring, using performance metrics to track compliance and drive improvements in oversight.
• Responsible for site and monitoring quality using interpretive signals in conjunction with local country intelligence to proactively identify risks. Lead risk assessment at the site/country level for designated studies, including identification of mitigation and control. Maintain knowledge of appropriate tools and resources (e.g., metrics, site health, Risk Based Monitoring signals, etc.) and demonstrate use of data to enhance quality and accelerate study delivery. Track site engagement metrics and satisfaction scores.
• Performance management of direct reports. Demonstrate a learning culture by ensuring site quality and trends, including preventative actions are shared across study & assets in the clinical programs to drive accelerated drug delivery.
• Be the point of escalation for issues that arise in site engagement, escalating as necessary and keeping the relevant Clinical Operations study team informed of escalation and resolution. Effectively solve problems and use judgment relating to national and international regulations, guidelines, investigator interactions and timelines.
• Align with Clinical Operations and Clinical stakeholders to ensure strategy and approach for clinical programs and studies is appropriate to meet study goals while incorporating study engagement team, including CRA monitors.
• Drive ongoing department infrastructure development efforts such as SOP development, risk management programs, implementation and/or innovation of new processes and clinical system capabilities to consistently deliver operational excellence.
• Partner on important projects and stay current with relevant industry trends and innovations to ensure best practices in study site engagement are applied across Eikon.
• Serve as a talent magnet and develop, coach, and retain top talent in the team. Set clear performance standards and holds self and organization accountable for achieving results. Embraces metrics and performance standards (KPIs).

Benefits

• 401k plan with company matching
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
• Mental health and wellness benefits
• Weeklong summer and winter holiday shutdowns
• Generous paid time off and holiday policies
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
• Enhanced parental leave benefit
• Daily subsidized lunch program when on-site

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 101-250 employees