We are seeking an experienced and strategic Associate Director, Clinical Operations to lead the execution of global clinical development programs and support the advancement of innovative therapies. This role is responsible for the planning, oversight, and successful delivery of complex clinical studies and programs, ensuring compliance with regulatory requirements, quality standards, timelines, and budgets.
The ideal candidate is a collaborative leader with clinical operations experience, a strong understanding of global clinical trial regulations, and a proven ability to manage CROs, vendors, and cross-functional stakeholders in a fast-paced biotechnology environment.
Objectives
Clinical Program Leadership
- Lead and oversee the execution of multiple clinical studies within assigned development programs.
- Drive operational strategy and execution to support clinical development plans and overall program objectives.
- Manage complex studies that may involve multiple indications, interim analyses, DSMBs, endpoint review committees, and global vendors.
- Ensure studies are delivered on time, within budget, and in compliance with ICH-GCP, regulatory requirements, and company procedures.
- Oversee project scope, critical path activities, timelines, milestones, and risk mitigation plans.
Vendor and CRO Oversight
- Select, manage, and oversee CROs and external vendors to ensure high-quality performance and delivery of contracted services.
- Lead vendor budget discussions, contract negotiations, and performance management activities.
- Escalate and resolve operational challenges and vendor performance issues as needed.
- Partner with CROs to develop study management, enrollment, communication, monitoring, and risk management plans.
Financial and Strategic Management
- Develop and manage program budgets and forecasts.
- Collaborate closely with Finance to ensure accurate forecasting, enrollment projections, and spend management.
- Provide regular updates to senior leadership regarding program status, risks, timelines, and financial performance.
- Support operational due diligence activities for new compounds, partnerships, and business development opportunities.
Cross-Functional Collaboration
- Serve as the primary Development Operations representative for assigned programs.
- Partner with Clinical Development, Regulatory Affairs, Medical Writing, Biostatistics, Data Management, and other stakeholders to ensure seamless study execution.
- Participate in audit and inspection readiness activities and support regulatory interactions.
- Contribute to departmental process improvements, strategic initiatives, and operational excellence efforts.
Regulatory and Documentation Support
- Contribute operational expertise to the development and review of key clinical development documents, including:
- Protocols
- Clinical Study Reports (CSRs)
- Investigator Brochures
- INDs and IMPDs
- NDA and MAA submissions
- Enrollment and risk management plans
- Support preparation for regulatory agency meetings and health authority interactions.
Leadership and Mentorship
- Provide guidance, mentorship, and support to Clinical Operations team members and cross-functional colleagues.
- Contribute to department training, development initiatives, and resource planning.
- Foster a culture of accountability, collaboration, quality, and continuous improvement