Intern, Clinical 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><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong><span data-contrast="auto">Position</span></strong><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span data-contrast="auto">This 10-week summer internship provides an opportunity to gain hands-on experience within the Regulatory Affairs function in a collaborative, fast-paced clinical development environment. The Regulatory Affairs Intern will support regulatory intelligence, development landscape assessment, and regulatory communication workflow initiatives that help guide global drug development strategies.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span data-contrast="auto">In this role, you will gain exposure to regulatory strategy, clinical development planning, and regulatory communication processes. This internship is designed to provide experience working with regulatory intelligence databases, analyzing clinical trial landscape data, and supporting regulatory documentation and communication workflows that support program advancement.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong><span data-contrast="auto">About You</span></strong><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span data-contrast="auto">You are interested in learning how regulatory strategy supports drug development and are excited to work with scientific data, clinical trial information, and regulatory documentation. You are detail-oriented, analytical, and comfortable synthesizing complex scientific information into clear written summaries and presentations. You are organized, collaborative, and motivated to learn how regulatory teams support clinical development programs.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span><strong><span data-contrast="auto">What You’ll Do</span></strong><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></span></p> <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;" data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span data-contrast="auto">Perform research to drive development of regulatory strategy for a clinical development program.</span> </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;" data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Utilize regulatory intelligence and public clinical trial databases to conduct development landscape assessments. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;" data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Review publicly available regulatory documents (e.g., FDA approval summaries, advisory committee materials) to identify common regulatory considerations and decision drivers. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;" data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Develop and maintain MS Excel trackers summarizing relevant clinical trial information, including indication, phase, patient population, endpoints, and other key study attributes. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;" data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Analyze clinical trial and regulatory landscape data to support internal program planning. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;" data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Review regulatory communications related to active development programs. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;" data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Support development of written summaries and slide decks that outline regulatory communication workflows and internal review processes. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;" data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Support internal regulatory knowledge management by organizing guidance documents, terminology, and key learnings. <span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;" data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Assist with updates and quality review of internal regulatory tracking tools and documentation. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;" data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Present internship project outcomes and key learnings.<span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></span></li> </ul> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong><span data-contrast="auto">Qualifications</span></strong><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></span></p> <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;" data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span data-contrast="auto">Currently enrolled in an accredited university pursuing a Bachelor’s or graduate-level degree in Biology, Chemistry, Pharmacology, Life Sciences, or a related discipline.</span> </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;" data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Entering junior year of a bachelor’s program or currently enrolled in a graduate-level degree program at the start of the internship. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;" data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Must be enrolled in school during the internship program. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;" data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Background in life sciences with completion of coursework in technical or scientific writing. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;" data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Basic understanding of drug development and pharmacology principles. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;" data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Strong proficiency in Microsoft Word, Excel, and PowerPoint. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;" data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Strong analytical skills with ability to interpret scientific and clinical information. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;" data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Strong written and verbal communication skills with attention to detail. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;" data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ability to organize and synthesize complex information into clear summaries and presentations. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;" data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ability to work collaboratively in a team environment while managing multiple deliverables. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;" data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Must be available to work full-time (40 hours per week) during core business hours for a minimum of 10 weeks during the summer internship program.<span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></span></li> </ul> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span data-contrast="none">The expected hourly pay range for this role is $36 - $48/hour. Placement within this range is determined based on education level.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></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>