--- title: 'Associate Director, Clinical Regulatory at Eikon Therapeutics' canonical: 'https://feeny.ai/job/associate-director-clinical-regulatory-eikon-therapeutics-jersey-city-k85gtnexs2a1' type: 'job' last_seen: '2026-09-06' --- # Associate Director, Clinical Regulatory at Eikon Therapeutics - **Company:** Eikon Therapeutics - **Location:** Jersey City, NJ - **Posted:** 2026-09-04 - **Last confirmed live:** 2026-09-06 - **Apply:** https://job-boards.greenhouse.io/eikontherapeutics/jobs/5231330007 ## 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 We are seeking an experienced Associate Director, Clinical Regulatory, to manage our regulatory clinical trial applications (CTAs) and compliance efforts. In this critical role, you will be responsible for ensuring that our biotechnological innovations align with all relevant regulations and standards. You will collaborate with cross-functional teams to develop ex-US CTAs, and manage the maintenance of applications submitted to Competent Authorities (CAs) in support of study initiation. This role is a member of the program teams within the function of Regulatory Affairs. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in the Jersey City, New Jersey, office to ensure effective management, operational excellence and collaboration with the cross-functional teams. ## About You The ideal candidate for this role is a seasoned regulatory professional who possesses in-depth knowledge of ex-US regulatory requirements and guidelines, coupled with exceptional project management, coordinating and communication skills. Their proven ability to thrive in a fluid, fast-paced collaborative, cross-functional team environment, along with strong analytical skills, attention to detail, effective problem-solving abilities, efficient execution, and adaptability, makes them well-suited for the position. In this role, they will excel in developing and executing global CTA submission strategies, ensuring compliance, managing submissions, fostering cross-functional collaboration, liaising with regulatory agencies, supervising quality assurance, and addressing regulatory risks associated with programs. ## What You’ll Do - Global Clinical Trial Application (CTA) Submission Strategy: - Develop and execute comprehensive regulatory CTA submission strategies that support clinical trial initiations ex-US and related, while aligning with the company's strategic objectives. - Provide advisory to and work with cross-functional teams on developing responses to health authority questions. - International Regulatory Compliance: - Advise and stay abreast of evolving ex-US regulations, guidelines, and industry best practices. - Ensure that the company's activities and products adhere to all applicable regulatory requirements. - Maintain detailed knowledge of regulations such as EU-CTR (Regulation EU No 536/2014), International Conference on Harmonization (ICH), and country-specific regulations. - Submission Management: - Develop and coordinate on the preparation, review, and submission of submission packages and regulatory documents for countries such as in Europe (European Union [Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic (Czechia), Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden], other European countries, UK, Norway, Switzerland, Iceland), Latin America, Asia Pacific (including Australia, New Zealand, China, South Korea), and rest of the world (ROW). - Develop ex-US dossier content plans in coordination with cross-functional teams. - Maintain international CTA lifecycles. - Cross-Functional Collaboration: - Collaborate closely with Study Start-Up (SSU), Clinical Operations Study Management, Clinical Supply Chain, CMC, and other teams to provide regulatory guidance and ensure the seamless integration of regulatory considerations into the product development process. - Communication with Regulatory Agencies: - Act as a liaison with regulatory agencies, fostering effective communication and negotiation regarding submissions, and inquiries. - Quality Assurance: - Supervise regulatory aspects of quality systems, including compliance with Good Clinical Practices (GCP), and General Data Protection Regulation (GDPR). - Risk Assessment: - Identify and assess regulatory risks associated with projects and proactively propose solutions to mitigate these risks. ## Qualifications - 10+ years of relevant experience with a Bachelor's degree, or 8+ years with a post graduate degree, in a relevant scientific discipline preferred - In-depth knowledge of international regulatory requirements and guidelines. - Ability to interface well with submission platforms such as Clinical Trials Information System (CTIS), or Integrated Regulatory Information System (IRIS). - Familiarity also with study and GMP documentation required by Health Authorities. - Exceptional communication, negotiation, and project management skills. - Proven ability to thrive in a collaborative, cross-functional team environment. - Strong analytical skills, attention to detail, and effective problem-solving abilities. - Adaptability and the ability to excel in a fast-paced, high-growth environment. - Proficient computer skills, strong electronic technical aptitude. - Working knowledge of Veeva, Microsoft Office (including Word, Excel, PowerPoint, Project) and Windows. 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 $178,000 to $215,250 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 - [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 Clinical Quality Operations Manager](https://feeny.ai/job/senior-clinical-quality-operations-manager-eikon-therapeutics-jersey-city-cktq0jdk1mn1) — Jersey City, NJ / 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