Eikon Therapeutics · 1 day ago
Director, Site Engagement & Monitoring Excellence
Jersey City, NJ
Full-time
Onsite
Director/Executive
$204K/yr - $223K/yr
10+ years expEikon 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. The Director Study Site Engagement & Monitoring Excellence will lead the development and execution of Eikon’s global trial site engagement strategy, ensuring high-quality data delivery and collaboration with clinical study teams and partners.
BiotechnologyHealth CareLife ScienceMedical
Responsibilities
Define and implement site engagement strategies to improve relationships
Support the build of new partnerships and networks
Support high quality monitoring approaches and ensure alignment with regulatory standards
Serve as liaison between clinical study teams and investigative sites
Provide guidance, oversight and training to the study site engagement team, including CRA site monitors, whether insourced or outsourced suppliers, to maximize effectiveness and acceleration in Eikon’s operational execution of clinical research
Develop and maintain appropriate performance standards, processes and documentation for harmonized site engagement and monitoring support across Eikon’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, including identifying and managing CRA performance issues. 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
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
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
Manage functional budget, including resource projections, capacity assessment and vendor (e.g., FSP) oversight and evaluation, to ensure adequate and appropriate resourcing for Eikon’s clinical trial portfolio
Align with global Clinical Development 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
Contribute to ongoing department infrastructure development efforts such as SOP development, implementation and/or innovation of new processes and clinical system capabilities to consistently deliver operational excellence
Collaborate with Clinical Development leadership to 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)
Qualification
Required
Post Graduate degree with 10+ years of experience or a Bachelor's degree with 12+ 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
Leadership skills that enable and drive alignment with the goals, purpose and mission of our company
Travel: up to 25% travel expected
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
Company
Eikon Therapeutics
Eikon Therapeutics is a biopharmaceutical company that develops live-cell resolution microscopy and engineering for drug discovery.
201-500 employees
H1B Sponsorship
Eikon Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (17)
2023 (7)
2022 (3)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
$1.12BKey Investors
The Column Group
2025-02-26Series D· $350.7M
2023-06-01Series C· $106M
2022-01-06Series B· $518M
Leadership Team
Roger Perlmutter
Chairman, President, and CEO
Michael Klobuchar
Chief Operating Officer
Recent News
General Catalyst
2025-12-26
2025-12-02
Company data provided by crunchbase