Associate Director, Clinical Study Management

divh2Associate Director, Clinical Study Management/h2pEikon 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. Eikons 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./ppThe Associate Director, Clinical Study Management, will be responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas, as required. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our California office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth collaboration. The successful candidate will work closely with cross-functional Clinical Research 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./ppThis role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth collaboration./ph3About You/h3pYou are collaborative, solutions oriented, flexible and have global clinical operational experience, with a passion for excellence in advancing patient care in oncology./ph3What Youll Do/h3ulliTeam leader and builder, who manages clinical trial deliverables, timelines, and budgets per the Clinical Development and Operational Plans/liliWorks with minimal oversight from the Clinical Operations Senior Director or Director, in collaboration with Clinical Study Management teams and Clinical Research and Development functional teams/liliDemonstrate broad understanding of therapeutic and clinical drug development expertise to influence study design and program-level decisions/liliProvide direction to cross-functional study teams to ensure successful study execution Ensure that clinical studies are conducted following approved protocols, FDA Regulations, ICH-GCP, EMA, PMDA, other relevant regulations, directives, and guidelines, and company procedures and quality documents/liliOversee risk identification, assessment, and mitigation strategies to ensure patient safety and data integrity/liliResponsible for the implementation of processes and systems that will facilitate inspection readiness throughout the lifecycle of the trial./liliOversee the preparation and maintenance of detailed clinical trial project timelines/liliManage ancillary (non CRO) vendor relationships and performance to ensure that clinical studies are completed following contract specifications of time, cost and quality./liliWork with finance, legal, and external vendors to ensure the assigned studies are meeting the target milestones/liliProvide regular updates on study progress to stakeholders (e.g., Clinical Operations, Project Portfolio Management, Clinical Research)/liliEnsure that all study-related documents are accurate, complete, timely and filed appropriately in all clinical (Veeva TMF), regulatory, safety and finance systems./liliResponsible for hiring, performance management, career development, and providing mentorship to Clinical Study Management personnel./liliContribute to initiatives and projects adding value to Eikon Therapeutics/li/ulh3Qualifications/h3ulliMinimum of 10 years of related experience with a Bachelors degree or 8 years and a post-graduate degree./liliExperience leading large, global clinical trials, preferably in oncology/liliIn-depth knowledge of ICH-GCP, EMA guidelines and other relevant regulations and guidelines./liliProven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety./liliStrong leadership and communication skills, with a demonstrated ability to work collaboratively with cross-functional teams./liliExperience with management of the budget, resources, headcount, processes and controls, productivity, quality and project delivery./liliHigh sense of accountability and urgency to prioritize deliverables./liliGrowth mindset and capable of working independently./li/ulpAt Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:/pulli401k plan with company matching/liliMedical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)/liliMental health and wellness benefits/liliWeeklong summer and winter holiday shutdowns/liliGenerous paid time off and holiday policies/liliLife/ADD Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/ADD policies/liliEnhanced parental leave benefit/liliDaily subsidized lunch program when on-site/li/ulpThe expected salary range for this role is $183,000 to $199,500 depending on skills, competency, and the market demand for your expertise./ppEikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment. 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./p/div