Director, Site Engagement & Monitoring Excellence at Eikon Therapeutics

Jersey City, New Jersey, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, Clinical ResearchIndustries

Requirements

Minimum of 3 days a week onsite presence (or more as business needs require) in either California or New Jersey offices
Expertise in defining and implementing site engagement strategies aligned with regulatory standards (e.g., ICH GCP)
Knowledge of high-quality monitoring approaches, risk-based monitoring, site health metrics, and data-driven tools for quality enhancement
Ability to oversee resource and talent management, including insourced/outsourced CRAs and FSP partners across regions/countries
Experience in training, performance management, and corrective/preventative actions for site engagement teams
Strong collaboration skills with clinical study teams, investigative sites, and stakeholders

Responsibilities

Define and implement global trial site engagement strategies to improve relationships and establish Eikon as a preferred sponsor
Support building new partnerships and networks with clinical sites
Support high-quality monitoring approaches ensuring 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 (insourced or outsourced)
Develop and maintain performance standards, processes, and documentation for harmonized site engagement and monitoring across clinical programs
Maintain regular information exchange within the team, codify lessons learned, troubleshoot issues, and distribute site intelligence to study teams and stakeholders
Oversee resource and talent management of site engagement team and CRAs across regions/countries to achieve study goals
Accountable for oversight and training of FSP, site engagement, and CRAs by country/region, managing performance issues and ensuring ICH GCP compliance, quality, and timelines
Proactively identify risks at site/country level using interpretive signals and local intelligence; lead risk assessments, mitigation, and controls
Track site engagement metrics and satisfaction scores; demonstrate use of data/tools to enhance quality and accelerate delivery
Foster a learning culture by sharing site quality trends and preventative actions across studies and assets

Skills

Key technologies and capabilities for this role

Site EngagementClinical MonitoringCRA OversightRegulatory ComplianceSite Relationship ManagementClinical OperationsStrategic LeadershipTeam TrainingPartnership BuildingTrial Management

Questions & Answers

Common questions about this position

Is this role remote or does it require office presence?

The role requires a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices.

What experience is required for this position?

A minimum of 3 days a week onsite is implied through the role's demands, but specific years of experience are not detailed; leadership in clinical site engagement and monitoring is key.

What are the main responsibilities of the Director role?

The role involves leading global trial site engagement strategy, overseeing site monitoring activities, ensuring high-quality data delivery, and collaborating with clinical teams and FSP partners.

What is the company culture like at Eikon Therapeutics?

The culture emphasizes effective collaboration, high-performance delivery, operational excellence, and supporting significant team growth.

What makes a strong candidate for this Director position?

Strong candidates will have expertise in clinical operations, site relationship management, monitoring oversight, and the ability to lead teams across regions while ensuring regulatory alignment and operational acceleration.

Eikon Therapeutics

Biotech startup developing innovative medicines

About Eikon Therapeutics

Eikon Therapeutics focuses on discovering and developing new medicines in the pharmaceutical industry. The company employs advanced technologies to study biological systems, aiming to identify new drug targets by examining the dynamic aspects of biology rather than just static chemical processes. Their team consists of diverse professionals, including data scientists, chemists, and engineers, which allows them to combine science and engineering to create new therapies that aim to improve and extend life. A key feature of Eikon's approach is their proprietary single-molecule tracking (SMT) platform, which enables rapid visualization of protein movements in living cells. This technology, along with artificial intelligence and automation, allows for precise inventorying of molecular interactions. Eikon Therapeutics targets patients with serious diseases who need effective treatments, generating revenue through the development and commercialization of their therapies.

Hayward, CaliforniaHeadquarters

2019Year Founded

$750.8MTotal Funding

SERIES_CCompany Stage

AI & Machine Learning, BiotechnologyIndustries

201-500Employees

Benefits

401(k) Company Match

Medical (premiums covered by Eikon at 95%)

Dental Insurance

Vision Insurance

Mental Health Support

Unlimited Paid Time Off

Paid Holidays

Life Insurance

Enhanced Parental Leave

Daily subsidized lunch program

Risks

Competition from biotech unicorns like Abogen Biosciences is increasing.

Integrating new clinical-stage assets may delay drug development timelines.

Reliance on SMT technology risks obsolescence from emerging molecular biology technologies.

Differentiation

Eikon uses proprietary single-molecule tracking for real-time protein movement analysis.

The company integrates AI and automation for large-scale molecular interaction studies.

Eikon's diverse team combines expertise in science, engineering, and technology.

Upsides

Growing interest in SMT technology boosts Eikon's drug discovery potential.

Partnerships with AI firms enhance Eikon's drug candidate identification.

Rising demand for precision medicine aligns with Eikon's focus on dynamic biology.

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