New

Senior Director, Site Engagement and Monitoring Excellence

Millbrae, CA; Jersey City, NJ

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.

Key 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.

Cross Functional Collaboration

  • 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).

Qualifications 

  • 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.
  • Travel: up to 25% travel expected

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 $230,000 to $251,750 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.

We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.

Create a Job Alert

Interested in building your career at Eikon Therapeutics? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Select...
Select...
Select...
Select...
Select...
Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Eikon Therapeutics’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.