Associate Director, Study Start Up (Site Budgets & Contracts) at Eikon Therapeutics

Jersey City, NJ Full-timeClinical OperationsPosted 24 days ago

About the Role

<div class="content-intro">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.</div>About You You know clinical site budgets from the inside: how a protocol translates into procedures, how procedure-level benchmarks and institutional overheads differ by country, and where negotiations typically stall. You are comfortable holding a firm, well-reasoned position with a site while keeping the relationship intact, and you know when to escalate. You bring structure to complex, cross-functional study start up work and use data to shorten cycle times rather than just report on them. Position Overview Eikon Therapeutics is seeking an Associate Director, Site Budgets & Contracts to join our Study Start Up group within Clinical Operations. This role is the Clinical Operations global subject-matter lead for investigator site budgets and clinical trial agreements (CTAs) across our oncology portfolio. You will own the strategy, standards, and execution for building, benchmarking, and negotiating site budgets so that CTAs are executed rapidly, consistently, and with a defensible Fair Market Value (FMV) basis, enabling on-time site activation. You will partner closely with Clinical Study Management, Legal, Finance, Regulatory, Data Management, and our contracting vendors, and you will be the escalation point for out-of-parameter budget and payment-term requests. This is a hands-on leadership role: you will negotiate directly on priority sites and studies while also setting the playbook that others follow. This role requires onsite presence at minimum 3 days per week to support effective management, operational excellence, and high-performance delivery of clinical studies and expected team growth & collaboration.   Key Responsibilities Site Budget Strategy and Development <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Serve as the global subject-matter expert and accountable owner for investigator site and country budget development across assigned oncology studies.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Interpret clinical protocols and schedules of assessment to build procedure-level site budgets, delineating standard-of-care versus research procedures and incorporating oncology-specific cost drivers (e.g., biopsies, biomarker and imaging assessments, patient stipends, drug handling).</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Establish and govern global and country-specific budget templates, including benchmarking methodology, overhead and indirect-cost assumptions, and invoiceable-item conventions.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Develop, document, and maintain the FMV rationale for site budgets in an audit-ready manner, in alignment with anti-kickback, anti-bribery, and transparency requirements.</li> </ul> Contract Negotiation and Execution <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Lead budget and payment-term negotiations with investigator sites and institutions, directly on priority studies and sites and through oversight of CRO or vendor contracting teams.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Define and maintain negotiation parameters, authority limits, and an escalation matrix in partnership with Legal and Clinical Operations; serve as the escalation point for out-of-parameter budget and payment-term requests.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Coordinate CTA and budget finalization with Legal (legal language), Finance (payment terms and accruals), and the investigator payments and Clinical Data Management functions to ensure clean handoff and accurate site payment setup.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Drive rapid, high-quality CTA execution to meet site activation targets across studies and countries.</li> </ul> Study Start Up Planning and Performance <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Partner with Clinical Study Management and Study Start Up (SSU) leads to develop and execute study start up plans aligned with project timelines and site activation goals.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Own budget and contract cycle-time metrics and KPIs; analyze industry benchmarks and internal data to forecast and accelerate contract execution and site activation timelines.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Contribute to country and site activation forecasts and scenario modeling in partnership with SSU Feasibility and Clinical Study Management.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Proactively identify budget and contracting risks and lead process improvements, playbooks, and tools that improve start-up efficiency and consistency across the portfolio.</li> </ul> Vendor, Stakeholder, and Team Leadership <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Provide oversight of CRO and outsourced site-contracting vendors, including quality review of budgets and negotiation positions, performance management against cycle-time targets, and issue resolution.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Build and maintain strong working relationships with investigative sites, institutional contracting offices, vendors, and internal stakeholders.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">May lead, coach, and develop Study Start-Up and site-contracting team members (direct or matrix), building organizational capability in site budgeting and negotiation.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ensure compliance with ICH-GCP E6(R3), applicable regulatory requirements, and internal SOPs throughout study start-up activities.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Perform other duties as assigned.</li> </ul> Qualifications <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Typically requires a minimum of: 10+ years of experience with a Bachelor's degree, or 8+ years with a post graduate degree. Extensive experience in clinical operations / study start up / investigator site budget roles.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Strong knowledge of clinical trial start up processes.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Demonstrated expertise building site budgets from protocols using procedure-level benchmarking tools (e.g., IQVIA GrantPlan), CPT and procedure-code mapping, and country-specific cost structures, with application of Fair Market Value principles.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Proven ability to successfully manage multiple clinical trials in study start up.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Excellent project management skills with a focus on delivering results within established timelines and budgets.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Strong interpersonal and communication skills, with the ability to build effective relationships with internal and external stakeholders.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Detail-oriented and organized, with the ability to prioritize tasks and adapt to changing priorities in a fast-paced environment.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Strong familiarity with Veeva Vault Clinical (CTMS and eTMF).</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Oncology clinical trial experience, including complex Phase 1–3 protocols with biopsy, biomarker, and imaging components, preferred</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Experience with US coverage analysis and Medicare Coverage Analysis (MCA) considerations in budget development, preferred</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Familiarity with feasibility and benchmarking sources (e.g., Citeline, TrialTrove/SiteTrove, KMR) and their use in startup forecasting, preferred</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Strong familiarity with Veeva Vault Clinical (CTMS and eTMF).</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Experience developing global CTA/budget templates and negotiation playbooks at a sponsor, preferred</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Clinical research or project management certification (e.g., ACRP, SoCRA, PMP), preferred</li> </ul> At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including: <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">401k plan with company matching</li> <li 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%)</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Mental health and wellness benefits</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Weeklong summer and winter holiday shutdowns</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Generous paid time off and holiday policies</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies </li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Enhanced parental leave benefit</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Daily subsidized lunch program when on-site</li> </ul> The expected salary range for this role is $166,000 to $200,550 depending on skills, competency, and the market demand for your expertise.<div class="content-conclusion">Eikon 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.</div>

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