Note: The job is a remote job and is open to candidates in USA. Skills Alliance 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 provide strategic leadership for planning and executing global clinical trials, ensuring compliance with regulatory standards and delivering operational excellence.
Responsibilities
- Lead the operational planning, start-up, execution, and close-out of global Phase I–II clinical studies, including First-in-Human trials
- Develop and manage comprehensive study management plans covering timelines, budgets, risk registers, enrollment projections, and resource allocation
- Oversee all 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 all 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
- Lead 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 contracts, work orders, and change orders in partnership with Finance and Legal
- Implement risk-based monitoring (RBM) frameworks aligned with ICH E6(R3) principles
- Ensure all clinical activities are conducted in strict compliance with ICH-GCP (E6 R2/R3), FDA, EMA, TGA, and other applicable global regulatory guidelines
- Maintain inspection readiness across all studies; lead or support responses to regulatory agency inspections, internal audits, and sponsor audits
- Develop, implement, and maintain clinical operations SOPs, work instructions, and quality processes
- Oversee 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
- Develop, manage, and track clinical operations budgets; provide accurate monthly accruals and forecasts in collaboration with Finance
- Identify operational risks and resource gaps proactively; develop and implement mitigation strategies
- Support portfolio-level resource planning and contribute to operational feasibility assessments for pipeline programs
- Lead, mentor, and develop a high-performing clinical operations team; establish clear goals, performance expectations, and development plans
- Foster a culture of quality, accountability, urgency, and continuous 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 related field
- Minimum of 10 years of progressive 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-Human studies, from start-up through CSR
- Extensive experience in full-cycle CRO management, including vendor selection, contract negotiation, and performance oversight
- Proven track record of delivering studies on time, within 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., Medidata Rave, Oracle 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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