Director, Clinical Operations

Responsible for the development of the program-level operational strategy and ensuring alignment across functions, e.g., E2E connectivity across functions, share lessons learned for program-level consistency, and monitor KPIs to track program-level success). Provide leadership during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues. Provide operational leadership and support to the Associate Directors Build a knowledgeable and skilled team with competencies and capabilities to successfully set up and deliver clinical trials Ensure Staff training on procedures and systems associated with their roles Develop a team that consistently achieves strong results through nurturing individual growth, effectively managing performance, and providing guidance Participates in, reviews, and provides direction on CRO and vendor outsourcing strategy, and key performance indicators (KPIs) ensuring vendor/ CRO partners consistently deliver high quality data to support regulatory requirements. Ability to effectively communicate the operational strategy and defend the operational plan and costs associated to CDST, leadership and at governance meetings as appropriate. Must have experience leading/managing externally outsourced, cross-functional teams. Experience in and knowledge of the pharmaceutical development process Clinical Research operational knowledge and deep experience across multiple phases of studies (1-4). Must have the ability to manage all aspects of execution of a clinical trial Excellent decision-making, analytical and strong financial management skills are essential to this position Strong project planning/management, communication and presentation skills Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness Experience leading without authority and in multifunctional matrixed and global environments Operate and execute with limited supervision Willingness and proven ability to work flexibly, stepping outside of immediate role responsibilities and wearing multiple hats where needed. Confident and has the professional competence to win respect and gain credibility at all levels within and outside the Company, and capable of successfully representing the Company externally. Strategic Thinking: General knowledge of all major aspects of drug discovery and development along with effective departmental leadership to be an effective problem solver for complex problems. BSc/ BA degree required - Advanced degree preferred. Proven previous experience gained with a CRO and/or biopharmaceutical company Demonstratable prior line management experience or in lieu extensive experience in a matrixed leadership environment required Ability to travel 10-15%.