Director, Clinical Study Management 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;"><strong>Position</strong></span></p> <p><span style="font-size: 12pt;">We are currently seeking an experienced leader for the clinical operations role of Director, Clinical Study Management within Clinical Study Management. &nbsp;The Director will manage all aspects of clinical operations study management for assigned Eikon clinical studies, and be responsible for exquisite inhouse execution of all such clinical trials and oversight of requisite clinical vendors. The role will also support the systematic pursuit of optimal performance, efficiency, and quality across the assigned clinical studies. Adherence to Good Clinical Practice (GCP), local and global policies and procedures to conduct high quality, inspection ready studies is essential. The Director is responsible for trial quality and audit responses and completion of CAPAs. The position has multiple stakeholder touch points within Clinical Research &amp; Development (CR&amp;D) staff and important interactions with, inter alia, Quality Assurance (QA), Finance, Regulatory, Clinical Supplies, Business Development and Legal in a matrix-based organization.</span></p> <p><span style="font-size: 12pt;">This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City, New Jersey or Millbrae, California offices to ensure effective management and high-performance delivery of clinical studies.<br></span></p> <p><span style="font-size: 12pt;"><strong>About You</strong></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">You are agile of mind, systematic, and a collaborative leader with global oncology clinical development experience and a passion for advancing patient care. You possess a deep understanding of clinical trial regulations, guidelines, and the principles of GCP, ensuring compliance throughout the clinical trial process.</span></p> <p><span style="font-size: 12pt;"><strong>What You’ll Do</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;">In collaboration with senior clinical operations management, build and lead inhouse clinical operations study management teams responsible for delivery of assigned clinical studies.&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;">Manage clinical study management personnel across assigned clinical studies.</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 compliance, quality and timeline objectives are met for all assigned studies.&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;">Work collaboratively in a matrix organization with all internal stakeholders to deliver company clinical trial objectives on time, on budget, and with high quality.&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;">Work with the CR&amp;D Functional Area (FA) leads, as appropriate, to accelerate enrollment and drive high quality.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Take responsibility for any assigned clinical trial audits, working closely with the Clinical Quality Assurance group.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Represent Clinical Study Management in process workstreams and initiatives.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Effectively solve problems and use judgment relating to national and international regulations, guidelines, investigator interactions, and timelines.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Effectively manage resources to ensure appropriately skilled and high performing staff members are assigned to support the effective execution of the portfolio and achieve CR&amp;D objectives.&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;">Responsible for ensuring appropriate scientific and operational training for staff members.&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;">Serve as a talent magnet and develop, coach, and retain top talent in the clinical program team.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Set clear performance standards and holds self and organization accountable for achieving results with flawless execution.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Embrace metrics and performance standards (KPIs) to drive continuous improvement in execution.</span></li> </ul> <p><span style="font-size: 12pt;"><strong>Qualifications</strong></span></p> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">12+ years of relevant experience with a Bachelor’s degree or 10+ years of relevant experience with a Master's Degree with a demonstrated working experience in clinical study management within the biotechnology, pharmaceutical, or healthcare industry.&nbsp;</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Relevant experience managing international clinical studies and programs in oncology.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Proven track record of contribution to and delivery of clinical trials that support global regulatory submissions, clean regulatory inspections and product approvals or marketing authorizations.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Relevant management experience in a clinical trial setting with the ability to service and collaborate with different CR&amp;D stakeholders in a matrix organization.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Demonstrated situational leadership, independence, problem solving abilities, self-motivation, resourcefulness and ability to work in a fast-paced team environment.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Relevant management expertise should cover management of budget, resources, headcount, processes (and controls), productivity, quality and project delivery.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">A complete understanding of ICH GCP and Global/Regional/Local regulatory requirements is required.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Strong communication skills requiring proficiency in written and spoken English.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Strategic thinking and high emotional intelligence.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Process improvement mindset and experience.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Strong leadership that will attract, motivate, inspire, develop and retain talented staff.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">In addition, leadership skills that enable and drive alignment with the goals, purpose and mission of our company.</span></li> </ul> <p><span style="font-family: helvetica, arial, 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: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">401k plan with company matching​</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, 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: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Mental health and wellness benefits​</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Weeklong summer and winter holiday shutdowns​</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Generous paid time off and holiday policies​</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, 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: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Enhanced parental leave benefit​</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Daily subsidized lunch program when on-site​</span></li> </ul> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">The expected salary range for this role is $203,000 to $221,350 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>