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Salary: USD 166,000 - 200,550 / annual
Eikon Therapeutics, a biopharmaceutical company founded on Nobel Prize-winning innovations in molecular imaging, is seeking an Associate Director, Study Start Up (Site Budgets & Contracts) to lead clinical operations strategy for investigator site budgets and clinical trial agreements (CTAs) across its oncology portfolio.
In this hands-on leadership role, you will serve as the global subject-matter expert and accountable owner for site budget development, benchmarking, and negotiation. You will 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 such as biopsies, biomarker and imaging assessments, patient stipends, and drug handling. You will establish and govern global and country-specific budget templates, including benchmarking methodology, overhead and indirect-cost assumptions, and invoiceable-item conventions. You will develop, document, and maintain Fair Market Value (FMV) rationale for site budgets in an audit-ready manner, aligned with anti-kickback, anti-bribery, and transparency requirements.
You will 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. You will define and maintain negotiation parameters, authority limits, and an escalation matrix in partnership with Legal and Clinical Operations, serving as the escalation point for out-of-parameter budget and payment-term requests. You will coordinate CTA and budget finalization with Legal, Finance, and the investigator payments and Clinical Data Management functions to ensure clean handoff and accurate site payment setup. You will drive rapid, high-quality CTA execution to meet site activation targets across studies and countries.
You will partner with Clinical Study Management and Study Start Up leads to develop and execute study start up plans aligned with project timelines and site activation goals. You will 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, and contribute to country and site activation forecasts and scenario modeling. You will proactively identify budget and contracting risks and lead process improvements, playbooks, and tools that improve start-up efficiency and consistency across the portfolio.
You will 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. You will build and maintain strong working relationships with investigative sites, institutional contracting offices, vendors, and internal stakeholders. You may lead, coach, and develop Study Start-Up and site-contracting team members (direct or matrix), building organizational capability in site budgeting and negotiation. You will ensure compliance with ICH-GCP E6(R3), applicable regulatory requirements, and internal SOPs throughout study start-up activities.
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 and collaboration.
**REQUIREMENTS:**
- Minimum 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, and 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)
- 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)
