<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><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Position </strong></span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>About You&nbsp;</strong></span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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.&nbsp;</span></p>
<p><br><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>What You’ll Do&nbsp;</strong></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;">Global Clinical Trial Application (CTA) Submission Strategy:</span></li>
<ul>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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.</span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Provide advisory to and work with cross-functional teams on developing responses to health authority questions. &nbsp;</span></li>
</ul>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">International Regulatory Compliance:</span></li>
<ul>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Advise and stay abreast of evolving ex-US regulations, guidelines, and industry best practices.&nbsp;</span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ensure that the company's activities and products adhere to all applicable regulatory
requirements. &nbsp;</span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Maintain detailed knowledge of regulations such as EU-CTR (Regulation EU No 536/2014), International Conference on Harmonization (ICH), and country-specific regulations.&nbsp;</span></li>
</ul>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Submission Management:</span></li>
<ul>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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).&nbsp;</span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Develop ex-US dossier content plans in coordination with cross-functional teams.</span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Maintain international CTA lifecycles. &nbsp;</span></li>
</ul>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Cross-Functional Collaboration:</span></li>
<ul>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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.</span></li>
</ul>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Communication with Regulatory Agencies:</span></li>
<ul>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Act as a liaison with regulatory agencies, fostering effective communication and negotiation regarding submissions, and inquiries. &nbsp;</span></li>
</ul>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Quality Assurance:</span></li>
<ul>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Supervise regulatory aspects of quality systems, including compliance with Good Clinical Practices (GCP), and General Data Protection Regulation (GDPR).</span></li>
</ul>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Risk Assessment:</span></li>
<ul>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Identify and assess regulatory risks associated with projects and proactively propose solutions to mitigate these risks.</span></li>
</ul>
</ul>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>
Qualifications</strong></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;">10+ years of relevant experience with a Bachelor's degree, or 8+ years with a post graduate degree, in a relevant scientific discipline preferred</span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">In-depth knowledge of international regulatory
requirements and guidelines.</span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ability to interface well with submission platforms such as Clinical Trials&nbsp;Information System&nbsp;(CTIS), or Integrated Regulatory Information System (IRIS).</span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Familiarity also with study and GMP documentation required by Health Authorities.</span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Exceptional communication, negotiation, and project management skills.</span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Proven ability to thrive in a collaborative, cross-functional team environment.</span></li>
<li 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 effective problem-solving abilities.</span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Adaptability and the ability to excel in a fast-paced, high-growth environment.</span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Proficient computer skills, strong electronic technical aptitude.</span></li>
<li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Working knowledge of Veeva, Microsoft Office (including Word, Excel, PowerPoint, Project) and Windows.</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&amp;D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&amp;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 $178,000 to $215,250 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>
About Eikon Therapeutics
Operator of a drug discovery and development platform intended to offer a novel treatment for life-threatening diseases.
