Senior Director, Head of Clinical Quality Assurance

Clinical/Medical New York, New York


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.


We are seeking an individual with strong leadership, advanced understanding of the regulations governing international drug development and the application of Quality Risk Management (QRM) principles, who is highly diplomatic, tactful and detail oriented with exceptional reasoning skills to lead and optimize our emerging Clinical Quality Assurance (CQA) organization supporting all functions within Clinical Development. This position includes operational quality management and inspection management activities.

About You

You are recognized as an expert resource on a range of compliance topics, with proven experience in managing oncology compliance programs, and you have superior oral and written communication and leadership skills in an international environment, coupled with excellent organizational and project management skills.

What You’ll Do

  • Provide leadership to the clinical quality assurance function: Build the best team and chart the course. This includes continual optimization of the organizational design and resources, ownership and optimization of key processes, talent and succession management, overall operating budget management and oversight of all clinical quality projects.
  • It is business critical that our company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. Lead the CQA function at Eikon, having oversight and accountability for global GCP quality assurance activities in support of clinical product development and clinical studies.
  • Responsible for developing and delivering strategic quality management and global GCP guidance, advice, tools and resources to clinical trial teams and functional lines in order to facilitate effective partnership, and oversight of clinical research.
  • Lead the creation, development and implementation of QRM and Quality by Design (QbD), and a to-be-identified Quality Management System (QMS) electronic system to ensure phase-appropriate compliant drug development for all therapeutic areas.
  • Proactively embed quality into our company sponsored trials, ensure adequate internal/external oversight (including suppliers) and address any quality issues as needed.
  • Support the development of quality plans, incorporating QbD within clinical development programs.
  • Lead the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow-up of regulatory inspections.
  • Support mergers and acquisitions of clinical research products and organizations to ensure comprehensive knowledge transfer, risk management and inspection readiness.
  • Train internal staff and develop the ability to be able to perform study quality control activities in order to identify emerging risks and process gaps at the clinical study level.
  • Responsible for performing periodic reviews of quality related clinical trial documentation for accuracy and completeness.
  • Develop and implement risk management organizational methodologies, tools and processes.
  • Responsible for the periodic review of critical data and processes at key stages of the clinical trial protocol lifecycle against the to-be-developed risk assessment categorization and issue management tools.
  • Lead and develop the knowledge and skills of the clinical organization, to support non-sponsor (e.g., clinical investigator site) and sponsor inspections.
  • Develop the knowledge and skills of the clinical organization, to be able to track and manage Corrective and Preventive Actions (CAPA) and associated regulatory commitments to completion, ensuring that key inspection documentation is maintained at all times.
  • Perform quality control review of key inspection document repositories to ensure presence and completeness of all key and essential documents (e.g., inspection reports, responses, internal CAPA plan, regulatory communication, CAPA evidence).
  • Lead and coordinate Quality Assurance audits, including: audit facilitation, root cause analysis for any applicable observations, development of responses, CAPA management and tracking.
  • Identify and drive continuous quality process improvements through assessment of audit inspection and quality event outcomes and identification of trends from internal deviations.
  • Provide guidance and training on relevant GxP regulations and guidelines to cross-functional business partners.
  • Serve as an expert and provide guidance on and interpretation of global GCP regulations and standards for internal stakeholders.
  • In coordination with Supplier Relationship Management & Performance (SRMP), develop knowledge of supplier oversight processes and requirements in order to be able to effectively support clinical trial teams and global functional lines in ensuring adequate sponsor oversight. This will include but not be limited to, development and maintenance of quality agreements, issue resolution, management of performance indicators, assistance with audits and inspections, risk management and data signals and trends.
  • Monitor industry best practices and identify opportunities for consistency and operationally excellent standards for CQA and risk management processes.
  • Ensure clinical trial compliance with all applicable laws and regulations and as appropriate, local, and foreign regulatory requirements.
  • Mentor, train, and manage junior level staff.


  • Bachelor’s degree with 12+ years; Master’s degree with 10+ years; PhD with 8+ years of research and development quality assurance compliance experience.
  • Must have broad GCP audit compliance experience. Clinical quality assurance and compliance experience in biopharma sponsor organization required.
  • Demonstrated knowledge of QRM, QbD principles and QMS.
  • Experience in managing oncology compliance programs required.
  • Experience in building a culture of quality, compliance, and growth and development in support of regulatory requirements in drug development and enabling the performance and operational excellence for individuals and clinical development teams required.
  • Experience in implementing principles for QRM (ICH Q9, ICH E6 R2) required.
  • Experience leading business process improvement projects required.
  • Experience with inspection and audit management/CAPA management programs required.
  • Must demonstrate a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop, and coach others, oversee, and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
  • Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues.
  • Ability to read, analyze an interpret common scientific and technical journals, financial reports, and legal documents. Ability to effectively present information to senior management, internal stakeholders, and external partners.
  • Proven ability to work independently in a dynamic, fast-moving environment, but also as part of a collaborative and innovative team.
  • Ability to manage assignments and effectively deliver all expected deliverables in an organized and a timely manner and proactively communicate changes in pre-established goals and deadlines.

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 $226,000 to $260,000, 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 be Fully Vaccinated with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA’s emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California’s Fair Employment and Housing Act, you will need to contact the Company’s Human Resources group. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.

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.