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

We need to output HTML fragment with sections: About the role? Actually the posting includes "About You", "Position Overview", "Key Responsibilities", "Qualifications", benefits, salary range. We need to use

for section headings (e.g., About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). We must not repeat job title as heading. We must include sections only when posting has real specific content. So we need sections: About the role? There's "Position Overview" which is about the role. Could map to "About the role". Also "Key Responsibilities" -> "Responsibilities". "Qualifications" -> "Qualifications". Benefits and Pay: there is a paragraph about compensation and benefits. So we can have "Benefits" and "Pay". Schedule: there is mention of onsite presence at minimum 3 days per week. That's schedule info. So we can have "Schedule". Also maybe "Skills"? Not needed if not explicit. We'll include only sections with content. We must not include boilerplate like EEO, equal opportunity, etc. Also remove application instructions, cookie/navigation, etc. The posting includes "Eikon is proud to be an equal opportunity employer..." and third-party agency stuff. Remove those. We need to preserve all substantive information. So we need to include the content from About You, Position Overview, Key Responsibilities (with bullet list), Qualifications (bullet list), Benefits, Pay, Schedule. We need to format lists with

• . For prose use

  . Use

  for headings. We must not repeat job title as heading. So no heading like "Associate Director, Site Budgets & Contracts". We'll just have sections. We need to ensure we don't include filler like "commensurate with experience". Not present. Let's extract content. About You paragraph: "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 paragraph: "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: list of bullet points under headings: Site Budget Strategy and Development, Contract Negotiation and Execution, Study Start Up Planning and Performance, Vendor, Stakeholder, and Team Leadership. Each has multiple sentences. We'll need to convert each bullet point into

  . The original has headings within responsibilities; we could treat each heading as a separate

  with sub-bullets? But spec says use

  • for any list of duties/requirements/benefits. So we can flatten: each duty as a
  • . Could keep the heading as part of the li text. Simpler: produce a
    with each responsibility sentence as
    • . Let's extract each bullet: - Site Budget Strategy and Development * Serve as the global subject-matter expert and accountable owner for investigator site and country budget development across assigned oncology studies. * 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). * Establish and govern global and country-specific budget templates, including benchmarking methodology, overhead and indirect-cost assumptions, and invoiceable-item conventions. * 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. - Contract Negotiation and Execution * 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. * 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. * 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. * Drive rapid, high-quality CTA execution to meet site activation targets across studies and countries. - Study Start Up Planning and Performance * 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. * 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. * Contribute to country and site activation forecasts and scenario modeling in partnership with SSU Feasibility and Clinical Study Management. * Proactively identify budget and contracting risks and lead process improvements, playbooks, and tools that improve start-up efficiency and consistency across the portfolio. - Vendor, Stakeholder, and Team Leadership * 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. * Build and maintain strong working relationships with investigative sites, institutional contracting offices, vendors, and internal stakeholders. * May lead, coach, and develop Study Start-Up and site-contracting team members (direct or matrix), building organizational capability in site budgeting and negotiation. * Ensure compliance with ICH-GCP E6(R3), applicable regulatory requirements, and internal SOPs throughout study start-up activities. * Perform other duties as assigned. Qualifications: list of bullet points. We'll extract each line. - 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. - Strong knowledge of clinical trial start up processes. - 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. - Proven ability to successfully manage multiple clinical trials in study start up. - Excellent project management skills with a focus on delivering results within established timelines and budgets. - Strong interpersonal and communication skills, with the ability to build effective relationships with internal and external stakeholders. - Detail-oriented and organized, with the ability to prioritize tasks and adapt to changing priorities in a fast-paced environment. - Strong familiarity with Veeva Vault Clinical (CTMS and eTMF). - Oncology clinical trial experience, including complex Phase 1–3 protocols with biopsy, biomarker, and imaging components, preferred - Experience with US coverage analysis and Medicare Coverage Analysis (MCA) considerations in budget development, preferred - Familiarity with feasibility and benchmarking sources (e.g., Citeline, TrialTrove/SiteTrove, KMR) and their use in startup forecasting, preferred - Strong familiarity with Veeva Vault Clinical (CTMS and eTMF). (duplicate) - Experience developing global CTA/budget templates and negotiation playbooks at a sponsor, preferred - Clinical research or project management certification (e.g., ACRP, SoCRA, PMP), preferred We have duplicate Veeva Vault line; we can keep one. Benefits paragraph: "At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including: 401k plan with company matching Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%) Mental health and wellness benefits Weeklong summer and winter holiday shutdowns Generous paid time off and holiday policies Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies Enhanced parental leave benefit Daily subsidized lunch program when on-site" We need to format as list maybe. It's a list after colon. We'll make
      • each item. Pay: "The expected salary range for this role is $166,000 to $200,550 depending on skills, competency, and the market demand for your expertise." Schedule: "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." Already mentioned in Position Overview but we can still include schedule section. We must not repeat content unnecessarily? The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. So we need to include that sentence somewhere. It's already in Position Overview; we could keep it there and not duplicate in Schedule. But we need a Schedule section only if posting has real specific content for it. The posting does mention onsite presence 3 days per week. That's schedule info. We could either include it under Position Overview or create a Schedule section with that sentence. If we create Schedule section, we would be duplicating the sentence (if we also keep it in Position Overview). The instruction says preserve ALL substantive information; does not forbid duplication, but better to avoid duplication? It didn't say avoid duplication, but we should not invent or summarize away detail. Duplication is okay but maybe not ideal. However, we could keep the sentence in Position Overview and not create a separate Schedule section, but then we would not have a Schedule section despite having schedule info. The rule: "include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text". It doesn't require we must have a Schedule section if schedule info exists elsewhere. It says include a section ONLY when the posting has real, specific content for it. So if we have schedule info, we could include a Schedule section with that content. If we also keep it in Position Overview, that's okay but might be duplication. However, the Position Overview already contains that sentence; we could keep it there and not duplicate. But then we would not have a Schedule section, but we still have schedule info present in Position Overview. The rule doesn't require we extract schedule info into its own section; it's just that if we create a Schedule section, it must have real content. It's optional to create it. The instruction: "Prefer a few substantive sections over many thin ones." So better to not create a thin Schedule section if we can incorporate schedule info elsewhere. However, the schedule info is a single sentence; making a separate section would be thin. So better to keep it within Position Overview or maybe under Responsibilities? It's already there. So we will not create a separate Schedule section. Thus sections: About the role (Position Overview + About You? Actually About You is separate; we could combine About You and Position Overview under About the role? The spec says use

        for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have About the role covering both About You and Position Overview. Or we could have About You as