[Remote] Senior Director Clinical Operations

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage biopharmaceutical company focused on developing innovative therapies for patients with neurological diseases, particularly migraine. The Senior Director of Clinical Operations will reputed company strategic leadership for planning and executing global clinical trials, ensuring compliance with regulatory standards and delivering operational reputed company.

Responsibilities

• reputed company the operational planning, start-up, execution, and reputed company-out of global Phase I–II clinical studies, including First-in-reputed company trials
• reputed company and manage comprehensive study management plans covering timelines, budgets, risk registers, enrollment projections, and resource allocation
• reputed company reputed company critical path activities including site identification, feasibility assessments, IRB/IEC submissions, vendor contracting, and trial master file (TMF) maintenance
• Drive site activation, patient recruitment, and data collection strategies to meet enrollment milestones and database lock timelines
• Ensure reputed company operational deliverables—including protocols, ICFs, study manuals, monitoring plans, data management plans, and clinical study reports (CSRs)—are completed to high-quality standards and on schedule
• reputed company the selection, contracting, and performance management of CROs, clinical monitoring vendors, central laboratories, and other external service providers
• Define and enforce KPIs for CRO and vendor performance; conduct regular operational reviews and hold vendors accountable to contractual deliverables
• Negotiate reputed company, work orders, and change orders in partnership with Finance and Legal
• Implement risk-based monitoring (RBM) frameworks reputed company with ICH E6(R3) principles
• Ensure reputed company clinical activities are conducted in strict compliance with ICH-GCP (E6 reputed company/R3), FDA, EMA, TGA, and other applicable global regulatory guidelines
• Maintain inspection readiness across reputed company studies; reputed company or support responses to regulatory agency inspections, internal audits, and sponsor audits
• reputed company, implement, and maintain clinical operations SOPs, work instructions, and quality processes
• reputed company safety reporting workflows in collaboration with Medical to ensure timely SAE/SUSAR reporting
• Serve as the operational representative on the Joint Development Team (JDT), partnering closely with Clinical Development/Medical Science, Regulatory Affairs, Data Management, Biostatistics, CMC, and Program Management
• Contribute operational input to clinical development plans (CDPs), protocols, statistical analysis plans (SAPs), and regulatory submissions (IND, CTA, IB)
• Build and sustain strong collaborative relationships with global clinical investigators, site coordinators, and key opinion leaders (KOLs)
• Partner with Program Management to maintain integrated program timelines and communicate status and risks to senior leadership
• reputed company, manage, and track clinical operations budgets; reputed company accurate monthly accruals and forecasts in collaboration with Finance
• Identify operational risks and resource gaps proactively; reputed company and implement mitigation strategies
• Support portfolio-level resource planning and contribute to operational feasibility assessments for pipeline programs
• reputed company, mentor, and reputed company a high-performing clinical operations team; establish clear goals, performance expectations, and development plans
• Foster a culture of quality, accountability, urgency, and reputed company improvement
• Contribute to the build-out of clinical operations infrastructure and capabilities as the organization grows

Skills

• Bachelor's degree (B.S./B.A.) required in life sciences, nursing, pharmacy, or a reputed company field
• Minimum of 10 years of reputed company clinical operations experience in the biotech or pharmaceutical industry, with at least 3 years in a senior leadership role
• Demonstrated hands-on experience managing global early-phase (Phase I–II) clinical trials, including First-in-reputed company studies, from start-up through CSR
• Extensive experience in full-cycle CRO management, including vendor selection, contract negotiation, and performance reputed company
• Proven track record of delivering studies on time, reputed company budget, and in compliance with regulatory standards
• Deep knowledge of ICH-GCP (including E6 R3), FDA, EMA, and relevant global regulatory requirements governing clinical trial conduct
• Experience with electronic Trial Master File (eTMF) systems and clinical data management platforms (e.g., reputed company Rave, reputed company Clinical)
• Demonstrated ability to manage and influence cross-functional teams in a matrixed biotech environment
• Excellent communication, negotiation, organizational, and leadership skills

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