Sr. Director, Clinical Operations Capabilities and Standards

Role Overview
Sr. Director, Clinical Operations Capabilities and Standards (Clinical Operations) — Somerset, NJ.

Responsibilities
- Provide strategic leadership and oversight for foundational/centralized trial operations support to scale Clinical Operations cost-effectively.
- Establish, oversee, and grow capability pillars: Clinical Trial Planning & Analytics; Clinical Trial Operational Technologies; Vendor Alliance Management; Site Contracts & Payments; Sample & Imaging Management Operations (including hiring, managing, and developing staff).
- Serve as subject-matter expert for clinical operations standards across the portfolio of Legend IND clinical trials.
- Oversee end-to-end clinical trial feasibility: protocol optimization, country/site selection, enrollment forecasting, and risk mitigation; deliver predictive trial performance modeling and contingency planning insights.
- Own and govern core clinical systems (e.g., CTMS, eTMF) and align systems with clinical operations needs and regulatory requirements; enable cost-efficient budgeting and technology-enabled risk management.
- Oversee external vendor/CRO alliances: due diligence coordination, GxP/compliance and contract expectations, governance, performance metrics, issue escalation, and continuous improvement.
- Create and oversee scalable site contracting and investigator payment operating model to improve operational control, process effectiveness, financial discipline, and sponsor–CRO–site workflow alignment.
- Lead end-to-end sample and imaging oversight; strengthen coordination across sites, CROs, labs, and imaging vendors; reduce patient data loss risk, accelerate data cleaning, and reduce site burden; be functional owner of relevant SOPs/guidance.

Requirements / Qualifications
- Bachelor’s degree (BA/BS) in scientific or health care discipline; advance degree preferred.
- 12+ years of progressive pharma/biotech clinical operations experience with global program leadership.
- Experience establishing/scaling centralized Clinical Operations capabilities (feasibility, operational technologies like CTMS/eTMF, vendor alliance management, site contracts/investigator payments, sample & imaging).
- End-to-end trial conduct expertise (early to late phase), including protocol development, feasibility, start-up, execution, and close-out.
- Strategic CRO/vendor oversight experience (governance, KPIs, financial oversight, escalation, continuous improvement).
- Functional/enterprise-level clinical operations SME experience defining standards and operating models across programs.
- Matrixed collaboration experience with Quality, Regulatory, Clinical Development, Data Management, Biostatistics, Medical Writing, Pharmacovigilance, Translational/Bioanalytical, Medical Affairs, Procurement, Legal, and IT.
- Regulatory interaction experience (e.g., FDA inspections) strongly preferred.
- Proven leadership in developing/retaining high-performing teams.
- Travel ~10% as required.
- Deep knowledge of clinical operations frameworks and regulatory expectations (ICH-GCP, FDA, global authorities).
- Strong operating model design, technology enablement (systems ownership, data quality oversight, inspection readiness), vendor governance/KPI frameworks, and understanding of sample/imaging/data flows.

Benefits / Application
- Please note: Benefits are offered exclusively to permanent full-time employees (contractors not eligible).