Associate Director, Study Startup (CONTRACT)
About The Position
Eikon Therapeutics is seeking an Associate Director, Contracts & Budgets Management and Negotiations to join its Study Start Up group within Clinical Operations. The role serves as the global subject-matter lead for investigator site budgets and clinical trial agreements across the oncology portfolio. The position owns the strategy, standards, and execution for developing, benchmarking, and negotiating site budgets so that CTAs are executed rapidly and consistently on a defensible Fair Market Value basis, enabling on-time site activation. The role partners with Clinical Study Management, Legal, Finance, Regulatory, Data Management, and contracting vendors. It is the escalation point for out-of-parameter budget and payment-term requests. This is a hands-on leadership position that includes direct negotiation on priority sites and studies as well as setting the playbook followed by others. The position requires onsite presence at least three days per week to support management, operational excellence, clinical study delivery, team growth, and collaboration.
Requirements
- Typically, at least 10 years of experience with a bachelor's degree, or at least 8 years with a postgraduate degree.
- Extensive experience in clinical operations, study start up, or investigator site budget roles.
- Strong knowledge of clinical trial start-up processes.
- Demonstrated expertise building site budgets from protocols using procedure-level benchmarking tools such as IQVIA GrantPlan, CPT and procedure-code mapping, and country-specific cost structures, applying Fair Market Value principles.
- Proven ability to manage multiple clinical trials in study start up.
- Excellent project management skills and ability to deliver 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).
Nice To Haves
- Oncology clinical trial experience, including complex Phase 1–3 protocols with biopsy, biomarker, and imaging components.
- Experience with US coverage analysis and Medicare Coverage Analysis (MCA) considerations in budget development.
- Familiarity with feasibility and benchmarking sources such as Citeline, TrialTrove/SiteTrove, and KMR and their use in startup forecasting.
- Experience developing global CTA/budget templates and negotiation playbooks at a sponsor.
- Clinical research or project management certification, such as ACRP, SoCRA, or PMP.
Responsibilities
- 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, distinguishing standard-of-care from research procedures and incorporating oncology-specific cost drivers.
- Establish and govern global and country-specific budget templates, benchmarking methodology, overhead and indirect-cost assumptions, and invoiceable-item conventions.
- Develop, document, and maintain audit-ready Fair Market Value rationale for site budgets in alignment with anti-kickback, anti-bribery, and transparency requirements.
- Lead budget and payment-term negotiations with investigator sites and institutions, directly for priority studies and sites and through oversight of CRO or vendor contracting teams.
- Define and maintain negotiation parameters, authority limits, and an escalation matrix with Legal and Clinical Operations; serve as the escalation point for out-of-parameter requests.
- Coordinate CTA and budget finalization with Legal, Finance, investigator payments, and Clinical Data Management to support clean handoffs and accurate site payment setup.
- Drive rapid, high-quality CTA execution to meet site activation targets across studies and countries.
- Partner with Clinical Study Management and Study Start Up leads to develop and execute 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 with SSU Feasibility and Clinical Study Management.
- Identify budget and contracting risks and lead process improvements, playbooks, and tools to improve start-up efficiency and consistency.
- Oversee 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 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, directly or through matrix relationships.
- Ensure compliance with ICH-GCP E6(R3), applicable regulatory requirements, and internal SOPs throughout study start-up activities.
- Perform other duties as assigned.
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What This Job Offers
Career Level
Senior
