layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

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

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.

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).
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
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

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

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