Director, Regulatory Affairs

<div class="content-intro"><p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">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.</span></p></div><p><strong><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Position</span></strong></p> <p data-start="437" data-end="992"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">We are seeking an experienced Director, Regulatory Affairs to support and execute regulatory strategy across our clinical-stage development programs. In this role, you will play a key role in both shaping regulatory strategy and driving hands-on execution across assigned programs. You will provide regulatory guidance throughout the development lifecycle, ensure alignment with FDA and international regulatory requirements, and partner closely with cross-functional teams to advance programs in a compliant, efficient, and high-quality manner. This role will report directly to the SVP, Regulatory Affairs and requires a minimum of 3 days per week onsite (or more as business needs require) in our Jersey City, NJ office to support effective cross-functional collaboration, operational excellence, and the evolving needs of our clinical development programs.</span></p> <p><strong><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">About You</span></strong></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">You are a seasoned regulatory affairs professional with strong hands-on experience navigating FDA and international regulatory frameworks. You are comfortable operating as a senior individual contributor who leads programs through influence, partnership, and subject-matter expertise, rather than formal people management. You bring excellent communication, organizational, and problem-solving skills, and thrive in highly collaborative, fast-paced environments where you are expected to both think strategically and execute with rigor.</span></p> <p><strong><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">What You'll Do</span></strong></p> <ul class="ul1"> <li class="li1" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Program-Focused Regulatory Leadership: Provide strategic and hands-on regulatory support across assigned clinical development programs, partnering closely with cross-functional teams to guide development and regulatory decision-making.</span></li> <li class="li1" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Regulatory Strategy: Contribute to the development and execution of regulatory strategies supporting product development, approval, and commercialization in alignment with company objectives.</span></li> <li class="li1" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Regulatory Compliance: Maintain current knowledge of evolving regulations, guidance, and industry best practices to ensure ongoing compliance across programs.</span></li> <li class="li1" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Submission Management: Lead and/or support the preparation, review, and submission of regulatory documents, including INDs, NDAs, and MAAs, as applicable.</span></li> <li class="li1" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Cross-Functional Collaboration: Work closely with Clinical Development, R&D, Quality, and other stakeholders to integrate regulatory considerations throughout the development lifecycle and drive alignment.</span></li> <li class="li1" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Quality Support: Support regulatory aspects of quality systems, including compliance with GCP and GLP requirements.</span></li> <li class="li1" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Risk Assessment: Identify regulatory risks, assess potential impact, and proactively recommend mitigation strategies.</span></li> </ul> <p><strong><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Qualifications</span></strong></p> <ul> <li class="li1" style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Post-graduate degree with 10+ years of relevant regulatory affairs experience, or a Bachelor’s degree with 12+ years of experience.</span></li> <li class="li1" style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Strong working knowledge of FDA and international regulatory requirements and guidelines.</span></li> <li class="li1" style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Demonstrated experience contributing to regulatory strategy and managing regulatory submissions.</span></li> <li class="li1" style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Excellent written and verbal communication skills, with the ability to influence cross-functional stakeholders.</span></li> <li class="li1" style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Strong analytical skills, attention to detail, and sound judgment.</span></li> <li class="li1" style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ability to thrive as an individual contributor in a dynamic, high-growth environment.</span></li> <li class="li1" style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Prior experience supporting oncology development programs is strongly preferred.</span></li> </ul> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​</span></p> <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">401k plan with company matching​</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Mental health and wellness benefits​</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Weeklong summer and winter holiday shutdowns​</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Generous paid time off and holiday policies​</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Enhanced parental leave benefit​</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Daily subsidized lunch program when on-site​</span></li> </ul> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">The expected salary range for this role is $213,000 to $232,750 depending on skills, competency, and the market demand for your expertise.</span></p><div class="content-conclusion"><p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.</span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">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.</span></p></div>