Associate Director, Clinical Study Management, EMEA/LATAM at Eikon Therapeutics

<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-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Position &nbsp;</strong></span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">The Associate Director, Clinical Study Management, EMEA/LATAM will be responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas, as required. This role will require onsite presence a minimum of 3 days a week to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth &amp; collaboration. The successful candidate will work closely with cross-functional Clinical Research &amp; 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 inhouse clinical study management.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">This role requires a minimum of 3 days per week onsite (or more, as business needs require) in either our Jersey City (NJ), or Millbrae (CA) offices.</span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>About You &nbsp;</strong></span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">You are collaborative, solutions oriented, flexible and have global clinical operational experience, with a passion for excellence in advancing patient care in oncology or neuroscience.</span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>What You’ll Do &nbsp;</strong></span></p> <ul> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Team leader and builder, who manages trial deliverables, timelines in assigned&nbsp;protocols across EMEA and LATAM to meet country commitments and&nbsp;regulatory requirements.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Works with minimal oversight from Clinical Operations Senior Director or&nbsp;Director, in collaboration with Clinical Operations teams and Clinical Research and Development functional teams.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ensure that clinical studies are conducted in accordance with approved protocols, ICH-GCP, EMEA, PMDA and other relevant regulations and guidelines.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Manage ancillary (non CRO) vendor relationships and performance to ensure that clinical studies are completed in accordance with contract specifications&nbsp;of time, cost and quality ensuring compliance with applicable regulations,&nbsp;guidelines, and company policies.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Work with finance, legal, external vendors and clinical sites to ensure the assigned studies are meeting the target milestones.&nbsp;</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Proven experience managing multi-center global clinical trials (Phases I–IV),&nbsp;with familiarity with regional nuances.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Keep up to date with regional regulations, health authority frameworks, treatment landscape and country requirements.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Manage regional resource planning, budgeting, forecasting, and key&nbsp;performance indicators (KPIs) for the region.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Provide direction to cross-functional study teams to ensure successful study execution.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Provide regular updates on study progress to stakeholders (e.g., Clinical Operations, Project &amp; Portfolio Management, Clinical Research).</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ensure that all study-related documents are accurate, complete, timely and filed appropriately in all clinical (Veeva TMF), regulatory, safety and finance&nbsp;systems. &nbsp;</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Oversee and be in compliance with Eikon processes, SOPs, clinical supply and&nbsp;ancillary supplies management, import/export requirements, insurance supply&nbsp;management.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Expected to lead, manage, hire regional Clinical Operations Study Management&nbsp;personnel across EMEA and LATAM, as required, to support operational&nbsp;excellence. </span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Contribute to initiatives and projects adding value to Eikon Therapeutics.</span></li> </ul> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Qualifications &nbsp;</strong></span></p> <ul> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Minimum of 10 years of related experience with a Bachelor’s degree; or 8 years&nbsp;and a post graduate degree. &nbsp;</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Fluency in English (strong reading, writing, and speaking skills and an ability to&nbsp;effectively communicate with colleagues and stakeholders at all levels) is required&nbsp;and ability to speak multiple EMEA/LATAM languages is a plus for this role. &nbsp;</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">In-depth knowledge of ICH-GCP, EMEA/LATAM guidelines and other relevant&nbsp;regulations and guidelines. &nbsp;</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Proven ability to manage clinical studies within timelines and budgets while&nbsp;maintaining high quality standards and patient safety. &nbsp;</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Strong leadership and communication skills, with a demonstrated ability to work collaboratively with cross-functional teams. &nbsp;</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Experience with management of the budget, resources, headcount, processes&nbsp;and controls, productivity, quality and project delivery. &nbsp;</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">High sense of accountability and urgency in order to prioritize deliverables. &nbsp;</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Growth mindset and capable of working independently.</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 $183,000 to $220,500 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>