Senior Director / Director, Clinical Operations
The Senior Director/Director, Clinical Operations is responsible for leading the strategy, planning, and implementation of clinical development programs in the Clinical Operations organization and contributing as the lead program level representative to the Zai Project Team (ZPT). This individual is responsible for providing advanced functional and technical expertise and insights from both a strategic (decision points, risk) and operational (timeline scenarios, feasibility, and financials) perspective to meaningfully contribute and make recommendations to clinical development plans to advance Zai Lab clinical programs. The Senior Director/Director, Clinical Operations helps define and implement vision and strategy for study management and is accountable for functional management including recruiting, building, and maintaining a high-quality clinical operations function.
Major Responsibilities and Duties:
- Through appropriate leadership, direction, and operational expertise, lead the development and execution of global operational strategies for multiple molecules/programs in Zai Lab's development portfolio.
- Recognized as an expert thought partner in drug development with a thorough understanding of all aspects of clinical drug development.
- Core member and Clinical Operations representative on the Zai Project Team serving as a primary consultant to senior-level colleagues, functional leadership, and cross-functional stakeholders.
- Contributes to the development of the clinical development plans and establishes the operational plan for a new program of study including scenario planning, high-level forecasting of timelines, assessment of program-level feasibility, estimation of resources and budget, and development of high-level operational strategies.
- Accountable for meeting all operational deliverables following time, cost, and quality commitments. Maintains an overview of the status, issues, and proactively communicates progress, issues, or changes that may impact timelines and costs of the program to all stakeholders. Maintains internal consistency across studies within a program.
- Provides program leadership to global cross-functional teams including external partners and vendors through oversight, guidance, strategies, and direction to achieve results.
- Provides innovative and flexible operational solutions with the ability to understand, critically assess and influence clinical development plans, protocol design, resource needs, budgets, and timelines for programs.
- Provides disease area expertise and input while anticipating changes in the disease landscape (e.g. standard of care) and regulations that impact operational strategies.
- May be assigned to one or more complex programs.
- Provide leadership, guidance, and manage performance and development of direct reports; administer performance programs following policies and ensure the development of potential succession candidates.
- Identify, recruit, and hire Clinical Operations Study Team staff, as well as oversee their work to ensure all goals, deliverables, and objectives are met; 30% of time spent leading and managing people.
- Ensure that employees are appropriately trained, developed, and coached to comply with company policies and Global regulations.
- Participate in and/or lead business improvement efforts within the Clinical Operations organization to improve clinical trial processes, systems, methodologies, and tools.
- Lead by example to create a positive work environment by encouraging mutual respect, innovation, smart risks, and accountability on a functional and project level, both locally and globally, to help the organization continuously evolve, improve, and excel.
Qualifications:- Undergraduate degree in a scientific or health-related discipline. Advanced scientific or business degree (MS/Ph.D./PharmD/MBS/MPH) preferred.
- Minimum of 10 years (12+ for Senior Director) experience in drug development, clinical research, and operational strategy experience including responsibility ensuring studies and programs are executed to quality, timelines, and budget.
- Demonstration of project/program management skills including risk assessment, timeline, and budget management, and contingency planning.
- Prior functional management experience.
- Excellent communication, management, and organizational skills, along with problem-solving, conflict resolution, and team-building skills.
- Experience across several complex therapeutic areas. Scientifically and clinical agile, proven ability to learn and apply relevant disease information into strategic operational planning and delivery.
- Ability to set clear vision/strategies and removes obstacles for teams that are barriers to doing productive/high-impact work.
- Proven ability to coach, develop, manage performance, and mentor personnel.
- Working knowledge of international regulatory and ICH Good Clinical Practice guidelines.
- Willingness to travel domestically and internationally and work across cultures.