Executive Director, Clinical Operations
Posted on Nov 18, 2018 by Affinity Executive Search
The Executive Director of Clinical Operations is accountable for the overall operational strategic planning, oversight and delivery of clinical development programs. The Executive Director is accountable for the line management of Clinical Operations staff, including development, coaching, talent planning and performance management. The Executive Director will also lead key strategic Clinical Operations organizational initiatives and be a member of the Clinical Operations Leadership Team.
RESPONSIBILITIES INCLUDING, BUT ARE NOT LIMITED TO:
* Accountable for the overall operational strategic planning, oversight and delivery of clinical development programs
* Oversee the development of study project plans, including timelines, metrics, budgets, and resources
* Manage and mentor the Clinical Operations team to ensure effective development, implementation and execution of clinical trials within agreed timelines, resources and budgets
* Develop and present operational plans to senior management
* Oversee and trouble-shoot clinical development program challenges, processes and activities with direct reports
* Actively participate as a member of the Clinical Operations Leadership Team in the development of organizational goals and strategies
* Lead key strategic Clinical Operations organizational initiatives by translating the vision into actionable strategies and ensuring that plans are executed per commitments. Includes the identification of process challenges, process enhancement, and training of study teams
* Ensure employees and contractors are appropriately trained to comply with company and regulatory standards
* Make recommendations to management on matters related to human resources, budget and department operations
* Recognized as a distinguished leader in Clinical Operations
TECHNICAL REQUIREMENTS & SKILLS:
* Bachelor degree or equivalent required (scientific or healthcare discipline preferred)
* 18+ years of progressively more challenging experience in clinical and drug development, with at least 10 years in a supervisory capacity
* Experience with international trials
* Rare disease clinical trial experience desired
* Ability to provide scientific and clinical expertise to a clinical development program
* Working knowledgeable of FDA regulations and ICH GCP guidelines is required
* Familiar with advanced concepts of clinical research (including complex study designs) and able to work effectively in a team/matrix environment
* Strong strategic planning and decision-making skills
* Ability to deal with time demands, incomplete information or unexpected events
* Must have the ability to build and maintain positive relationships with senior management, peers, and direct reports
* Focused on practical, commonsense and sensible approaches to finding effective solutions with a focus on embedding strong quality and compliance behaviors
* Willingness to work in a dynamic and changing corporate environment
* Previous experience leading key strategic functional initiatives
* Excellent written and verbal skills required. Must display strong analytical and problem solving skills
* Willing to travel domestically and internationally
* SET & ACHIEVE GOALS:Understand business objectives and effectively translate them into strategies, while skillfully navigating obstacles and resistance to change.
* INSPIRE & MOBILIZE OTHERS: Serve as a positive role model create followership and effectively mobilize and influence others, both on your team and across the organization.
* PROVIDE ONGOING COACHING & FEEDBACK:Coach others to achieve their goals through encouragement and high-quality feedback, and support the growth and development of team members.