Director, Head of Study Site Engagement and Monitoring Excellence

Company Description

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 disease. 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 of proteins as drug targets.

Position

We are currently seeking an experienced leader for the role of Director Study Site Engagement & Monitoring Excellence. The Director will lead the development and execution of Eikon’s global trial site engagement strategy, including oversight and accountability for all internal/external managed site monitoring activities, to ensure predictable delivery of high-quality data and establish Eikon as a preferred sponsor for clinical sites.

About You

The Director will oversee collaboration between clinical teams, Research & Development (R&D) partners and CRO or Functional Service Provider (FSP) partners, to implement site relationship management and site monitoring activities. They will oversee onboarding, and resource management of CRAs in order to ensure productive engagement of Eikon’s site-facing roles with clinical trials to develop lasting, collaborative relationships. These activities will enable study teams to conduct and deliver within timelines that contribute to predictable delivery for achieving R&D goals.

What You’ll Do

• Provide guidance, oversight and training to the study site engagement team, including CRA site monitors, whether insourced or via outsourced suppliers, to maximize effectiveness and acceleration in Eikon’s operational execution of clinical research.
• Develop and maintain appropriate processes and documentation for harmonized site engagement support across Eikon’s study portfolio.
• 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 of FSP, study site engagement and CRAs by country/region, including identifying 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.
• Demonstrate a learning culture by ensuring site quality and trends, including preventative actions are shared across study & assets in the clinical portfolio 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).

• Bachelor’s degree required, combined with a proven track record of contribution to and delivery of clinical trials that support global regulatory submissions, clean regulatory inspections and product approvals or marketing authorizations.
• 10+ years of experience in the pharmaceutical industry from recognized clinical trial suppliers/vendors, reputable CRO(s) and/or a Sponsor environment working on multi-phase, multi-therapeutic and diverse clinical trials.
• Significant management experience in a clinical trial setting with the ability to service and collaborate with different 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/Local 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.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 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​

The expected salary range for this role is $204,000 to $235,000 depending on skills, competency and the market demand for your expertise.

Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment. 

In accordance with the Company’s duty to provide and maintain a safe workplace, the Company requires all employees to have received both an FDA-approved primary vaccine series and at least one booster vaccine against COVID-19 as of their start date. If you are unable to meet this requirement due to a disability or serious medical condition, or due to a sincerely held religious belief, you will have an opportunity to request a reasonable accommodation.