---
title: 'Senior Clinical Quality Operations Manager at Eikon Therapeutics'
canonical: 'https://feeny.ai/job/senior-clinical-quality-operations-manager-eikon-therapeutics-jersey-city-cktq0jdk1mn1'
type: 'job'
last_seen: '2026-09-06'
---

# Senior Clinical Quality Operations Manager at Eikon Therapeutics

- **Company:** Eikon Therapeutics
- **Location:** Jersey City, NJ / Millbrae, CA
- **Posted:** 2026-08-12
- **Last confirmed live:** 2026-09-06
- **Apply:** https://job-boards.greenhouse.io/eikontherapeutics/jobs/5209869007

## Job 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 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

In partnership with the Director of Process Management for Clinical Research & Development, the Senior Clinical Quality Operations Manager (Sr. CQOM) is accountable for the execution of operational quality management and inspection readiness activities across Eikon's clinical development programs, to whom this role reports. The Sr. CQOM oversees clinical quality operations across assigned clinical programs, embedding quality-by-design principles, risk-based quality plans, and vendor oversight into Eikon's clinical trials. In partnership with Clinical Quality Assurance (CQA), the CQOM drives disciplined execution of quality plans and operational standards, enabling study teams to be inspection ready. This includes ensuring consistent execution of quality-by-design (QBD) principles across assigned clinical development programs and facilitating identification of Critical to Quality (CtQs) factors and associated risk assessments, establishing, and actively maintaining study-specific quality plans throughout the study lifecycle using a risk-based approach. The Sr. CQOM is accountable for the overall strategy to maintain inspection readiness through disciplined execution of risk assessments, quality plans and operational standards, in collaboration with Clinical Quality Assurance (CQA) on inspection preparation, management and follow-up activities.The successful candidate will work closely with cross-functional Clinical Research & Development teams to ensure successful completion of studies within timelines and budget, with a focus on exquisite quality to support operational excellence and world-class in-house clinical study management.

This role requires onsite presence at minimum 3 days per week to support effective management, operational excellence, and high-performance delivery of clinical studies and expected team growth & collaboration.

## About You

You are a collaborative, hands-on leader who enjoys working alongside clinical study teams to strengthen consistency, embed quality and drive disciplined trial execution. You bring credibility through deep knowledge of GCP and strong clinical operations expertise and are energized by cross-functional partnership. You are excited about the opportunity to shape a new function in a growing organization.

## What You'll Do

- Ensures consistent execution of 'quality by design' principles in assigned clinical trials. Reviews Risk Assessment and Categorization Tools (RACTs), quality plans, and study-specific procedures with Study Management Teams to confirm accuracy, compliance with Sponsor requirements, and inspection-readiness.
- Facilitates TA-level review of CtQs, quality plans and risk mitigation approaches to identify inconsistencies, emerging signals, and trends and to provide relevant feedback to the Head of Clinical Study Management and Director of Process Management for Clinical R&D, as appropriate.
- Works with Clinical R&D peers to analyze data across Eikon's clinical trials to identify signals and trends and translate findings into actionable process improvement strategies.
- In partnership with the Director of Process Management for Clinical R&D, the Head of Clinical Data Analytics and Reporting and the Head of Clinical Study Management, builds proficiency in leveraging technology and data to recognize and respond to new and emerging risks across the clinical portfolio, including how GCP applies to digital data management and novel trial technology.
- Partners with cross-functional study teams to ensure vendor and CRO performance is documented in vendor and CRO oversight plans and monitored against quality expectations, escalating compliance, or inspection-readiness risks to Clinical R&D functional area Heads, as necessary.
- Builds and enables effective working relationships with key stakeholders to ensure and maintain role clarity and business effectiveness. This will include ongoing partnership with Clinical R&D Clinical Quality Assurance (CQA) and acting as the link between Clinical R&D functional areas, clinical study teams, enterprise business functions, and regional study management.
- Contributes to the standardization of Clinical Quality Operations procedures, tools, and templates to ensure consistency and seamless progression throughout the study lifecycle.
- Maintains current, in-depth knowledge of global GCP inspection practices – including requirements from FDA, EMA, MHRA, and other established and emerging authorities – to effectively support GCP inspections worldwide. May serve as point of contact for a specific regulatory area (e.g., FDA, EMA, NMPA). Is responsible for monitoring, interpreting, and communicating relevant regulatory developments.
- Maintains current awareness of filing schedules, potential future inspections, and ongoing inspection preparation activities.
- Supports CQA in developing, updating, and maintaining GCP inspection procedures and guidelines within Clinical Development Operations and Clinical R&D functional areas.
- Contributes to the development and/or revision of Eikon policies, SOPs, and training materials.
- Ensures the operational foundation supports favorable inspection outcomes and that study teams execute consistently against study plans and operational standards.
- Partners with CQA to ensure the Clinical R&D functional areas are fully informed and prepared to support Regulatory Health Authority inspections led by CQA, worldwide.
- Escalates potentially significant compliance risks/impact to Clinical R&D functional area Heads, as necessary.
- Leads CAPA implementation for CQA-sponsored internal audits, partnering with study teams and functions to translate findings into process changes.
- For external audits and Regulatory Health Authority inspections, partners with study teams to develop CAPA responses and implement CQA-approved corrective actions requiring process, tool, or workflow changes.
- Coordinates education and training for study teams on process changes resulting from CAPAs, ensuring changes are understood, adopted, and sustained in practice.
- Provides RACT completion status, quality plan metrics, and other operational data to CQA for inclusion in GCP Quality Council meetings.
- Assesses and provides input to strengthen company programs/strategies with an aim to increase inspection readiness.
- Leads, drives, facilitates and/or supports remediation, prevention activities as process improvement and training, as needed.

## Qualifications

- Minimum of 8+ years of related experience with a Bachelor’s degree; or 6+ years with a post graduate degree. Additional certifications such as lean six sigma or PMP are preferred but not required.
- In-depth knowledge of GCP, ICH E6(R3) guidelines and other relevant regulations and guidelines.
- Demonstrated experience with CAPA management, including root cause analysis, preventive action development, translating CAPA findings into operational changes and tracking commitments to completion.
- Experience with risk management tools and quality planning in clinical development, including Quality by Design and risk-based approaches.
- Proven ability to work cross-functionally with clinical operations, quality assurance, regulatory, data management, and other clinical development teams in a matrixed environment.
- Superior oral and written communication skills in an international environment with the ability to influence at all levels.
- Excellent teamwork and leadership skills, including conflict resolution expertise.
- Ability to analyze, interpret and solve complex problems.
- Ability to think strategically and objectively while applying creativity and innovation.
- Ability to synthesize findings and deliver lessons learned.
- Experience with Veeva or similar document and quality management systems is a plus.

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 $157,000 to $189,000 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.

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.

## About Eikon Therapeutics

## Company Overview
- **One-liner**: Eikon Therapeutics is a late-stage clinical biopharmaceutical company that integrates single-molecule imaging, machine learning, and engineering to discover and develop novel therapies for oncology, immunology, and neuroscience.
- **Entity Type**: Public (NASDAQ: EIKN) – originally privately held, went public via a post-IPO equity round in 2026.
- **Headquarters**: Millbrae, California, United States
- **Founded**: 2019
- **Founders**: Not publicly named in the search results; the company was seeded by The Column Group.

## Core Business
- **Primary industry**: Biotechnology research and drug development (therapeutics)
- **Target customers**: Patients with unmet medical needs; the company partners with clinical research organizations, healthcare providers, and regulators.
- **Mission or purpose statement**: “Better insights will lead to better medicines” – the company aims to introduce new therapies that improve and extend life by deeply understanding human disease biology.

## Products & Services
- **EIK10 (TLR7/8 agonist)**: Phase 2 clinical program for solid tumors, leveraging immune response modulation.
- **VCP inhibitor (undisclosed target)**: Phase 1 program in oncology.
- **AR-v7 degrader**: Preclinical/early clinical program targeting androgen receptor splice variant in cancer.
- **PARP1 inhibitor**: Early-stage oncology program; also a CNS-penetrant PARP1 candidate for neuroscience.
- **AR degrader**: Preclinical androgen receptor degrader.
- **Discovery-stage programs**: Multiple undisclosed targets in oncology, immunology, and neuroscience, supported by the company’s single-molecule imaging platform.

## Market Standing
- **Valuation/Market Cap**: Not disclosed in search results; total funding of ~$1.5B as of mid-2026.
- **Key Metrics**:
  - Annual Revenue: $5.6M (reflective of early-stage, pre-commercial biotech).
  - Total Funding: $1.5B (seed, Series A $148M in 2021, Series B $518M in 2022, Series C $106M in 2023, and post-IPO equity of $381.2M in 2026).
- **Notable Investors/Partners**: The Column Group (lead seed/Series A), 18 investors in Series B, and multiple institutional partners across rounds; board includes industry veterans (e.g., Roger Perlmutter, former Merck CEO).
- **Growth Signals**:
  - Headcount grew ~2.7% YoY to 314 employees (2025–2026).
  - Active job postings increased 270% year-over-year (as of mid-2026).
  - Expanding pipeline into immunology and neuroscience beyond oncology.
  - Recent $351M financing event (reported by multiple outlets) to fund late-stage trials.

## Competitive Advantages
- **Proprietary single-molecule imaging platform** that enables real-time observation of protein dynamics at the single-molecule level, providing insights into disease mechanisms that traditional methods miss.
- **Machine learning integration** to analyze massive imaging datasets, accelerating target identification and drug design.
- **Deep bench of scientific talent**: Executives include Roger Perlmutter (CEO, ex-Merck), Roy Baynes (CMO, ex-Merck), and a team drawing from Genentech, Bristol Myers Squibb, Pfizer, and top academic institutions.
- **Cross-disciplinary approach** merging biology, engineering, and computation under one roof, reducing the “translation gap” between discovery and clinic.

## Strategic Focus
- **Advancing late-stage oncology pipeline**: Lead program (TLR7/8 agonist) in Phase 2, with plans to move into pivotal trials.
- **Expanding into new therapeutic areas**: Significant preclinical investment in immunology and neuroscience, with CNS-penetrant PARP1 and AR programs.
- **Continued platform development**: Scaling imaging and machine learning capabilities to enable faster, more precise drug discovery across multiple indications.
- **Building commercial infrastructure**: Post-IPO financing supports preparation for potential product launches and expanded clinical operations.

## Why Work Here
- **Culture**: Values-driven environment prioritizing execution, collaboration, innovation, transparency, respect, and caring for patients and colleagues.
- **Engineering & science fusion**: Opportunity to work at the intersection of advanced imaging, machine learning, and drug development – unique in biotech.
- **Growth trajectory**: Young company with strong funding, public listing, and rapidly expanding pipeline; employees can have significant impact.
- **Compensation**: Competitive base salaries (e.g., Software Engineer ~$140k, Senior Software Engineer ~$167k) plus equity incentives.
- **Work model**: Likely office-based at the Millbrae HQ or satellite labs in Hayward, CA; clinical roles may require travel; no explicit remote/hybrid policy in search results.
- **Perks**: Not detailed, but typical biotech benefits (health, 401k, PTO) are assumed; the company emphasizes a “transparent and inclusive culture” per its values.
- **Employee sentiment**: Overall rating 3.0/5 on LinkedIn (66 reviews); work-life balance 3.2, compensation 3.4, culture 3.0, career opportunities 2.9 – indicating room for improvement in career development.

## Sources
1. [eikontx.com](https://www.eikontx.com/)
2. [eikontx.com/about-us](https://www.eikontx.com/about-us/)
3. [eikontx.com/join-us](https://www.eikontx.com/join-us/)
4. [eikontx.com/pipeline](https://www.eikontx.com/pipeline/)
5. [linkedin.com/company/eikon-therapeutics-inc](https://www.linkedin.com/company/eikon-therapeutics-inc)

## Other roles at Eikon Therapeutics

- [Associate Director, Clinical Regulatory](https://feeny.ai/job/associate-director-clinical-regulatory-eikon-therapeutics-jersey-city-k85gtnexs2a1) — Jersey City, NJ
- [Senior Clinical Trial Manager, Oncology (APAC)](https://feeny.ai/job/senior-clinical-trial-manager-oncology-apac-eikon-therapeutics-jersey-city-vq62tce7x87v) — Jersey City, NJ / Millbrae, CA
- [Senior Director, Clinical Research (Medical Director)](https://feeny.ai/job/senior-director-clinical-research-medical-director-eikon-therapeutics-jersey-mcxrw0kk581x) — Jersey City, NJ
- [Staff Software Engineer, Machine Learning and Computational Chemistry](https://feeny.ai/job/staff-software-engineer-machine-learning-and-computational-chemistry-eikon-202k9e76vmy5) — Millbrae, CA
- [Sr. Director, Regulatory Affairs](https://feeny.ai/job/sr-director-regulatory-affairs-eikon-therapeutics-jersey-city-jkyatykrntds) — Jersey City, NJ
- [Senior Director, Total Rewards](https://feeny.ai/job/senior-director-total-rewards-eikon-therapeutics-millbrae-550rjqcker3j) — Millbrae, CA
- [Senior Informatics Engineer](https://feeny.ai/job/senior-informatics-engineer-eikon-therapeutics-millbrae-2g6dsjx5a73z) — Millbrae, CA
- [Senior Manager, Biostatistics](https://feeny.ai/job/senior-manager-biostatistics-eikon-therapeutics-jersey-city-cdzwe0z05kpz) — Jersey City, NJ
- [Senior Clinical Trial Manager, Oncology](https://feeny.ai/job/senior-clinical-trial-manager-oncology-eikon-therapeutics-millbrae-f90cz419kkaf) — Millbrae, CA / Jersey City, NJ
- [Senior Scientist, Analytical CMC](https://feeny.ai/job/senior-scientist-analytical-cmc-eikon-therapeutics-millbrae-y03yk2c2hwv6) — Millbrae, CA