The Associate Director (AD), Clinical Research is responsible for the planning, execution, monitoring and reporting of clinical research programs regionally for assigned products and indications. Programs will be conducted in compliance with all relevant regulatory regulations and guidelines to achieve strategic and operational departmental objectives. The AD will be responsible for managing the organization and conduct of regulatory and non-regulatory clinical programs in compliance with Clinical Operations policies and procedures, Regulatory Authority requirements and guidelines, and International Conference on Harmonization (ICH) Guidelines in support of global business objectives.
- Provides Clinical Research expertise input and leadership to cross functional project teams for assigned products and indications.
- Develops and maintains strong business relationships with sponsors and key opinion leaders.
- Responsible for the overseeing and coordinating the timely development of all essential project documents including project plans, protocols, informed consent forms, case report forms, and monitoring tools.
- Selection and management of external service providers to ensure project objectives are met within required timelines and budget through vendor contracting process.
- Ensure that clinical projects are conducted in compliance with all relevant regulations and guidelines.
- Conduct quality control visits to external service providers and investigational sites to assure regulatory compliance.
- Communication with Director, Clinical Research on project status, budgetary status, critical issues and challenges.
- Develop collaborative alliances and relationships with external service providers, investigators, key opinion leaders and advisors.
- Lead the planning and implementation of sponsor and investigator meetings and advisory boards in conjunction with external service providers.
- Contribute to clinical trial reports. Author and contribute to scientific publications and presentations for journals and symposium.
- Supports performance management and professional development of direct reports, including ongoing feedback, coaching, and career support.
- At least 10 years’ experience in clinical development gained in a CRO, Pharmaceutical or Biotechnology company.
- Excellent knowledge of the drug development process from pre-CTA/IND status through to post approval marketing studies.
- Good understanding of clinical research regulations and guidance in US, Europe and other international territories.
- Experience in third party service provider selection, contracting and management.
- Experience in managing budgets and familiarization with financial forecasting and cost accrual processes.
- Successful experience of operating in a resource constrained work environment. Global project management experience preferred.
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