Global Clinical Operations Program Director

GLOBAL CLINICAL OPERATIONS PROGRAM DIRECTOR Location: Gaithersburg, MD or Durham, NC. Can be a hybrid situation with up to 50% remote work. Project Description:

• Renowned expert in own field and may specialize in more than one area.
• Works independently with guidance in only the most complex situations.
• Coordinate the activity of a research team and holds full accountability for projects, often with Global impact.
• As a Global Clinical Operations Program Director, you will work in a global role within the Clinical Operations function of Late-Stage R&D (Biopharmaceuticals).
• The span of responsibilities is broad and may support one or several products depending on their size and complexity.
• The products supported may include studies in all phases of drug development.
• The Global Clinical Operations Program Director is responsible for oversight of a program of global studies, covering all clinical development deliverables (including aspects of quality, budget, time, resource, and risk).
• The role also involves integrating design, feasibility, and operational planning to ensure clinical drug development programs are aligned with priorities and strategy.
• The role will provide input & support to the Senior Global Clinical Operations Program Director in preparation for new business case opportunities for review by governance interactions and may act as the lead for cross-functional teams in delivery of various clinical activities and manage improvement or change projects within clinical operations or spanning multiple business areas.
• Lead cross functional teams of experts in the planning and delivery of a defined clinical program of studies and/or clinical activities to scope, quality, budget, time, planning the resource and managing risk.
• Work closely with global study leaders to provide appropriate strategic oversight of a program of studies on behalf of Sr Global Clinical Operations Program Director and Clinical Program Team (CPT) .
• Responsible for providing clinical operations expertise into the development of new business case opportunities for review by governance .
• Lead cross functional Clinical Submission Teams in planning and execution of clinical contribution to Marketing Applications, maintenance support for regulatory interactions and reports and inspection readiness.
• Lead large or complex deliverables and the process to identify and solve or raise operational issues.
• Drive delivery to plan through internal or external partners (alliance partners, Clinical Research Organizations (CROs), vendors and Academic Research Organizations (AROs)) .

• University degree (or equivalent), preferably in medical or biological sciences or subject area associated with clinical research.
• At least 10 years' experience from within the pharmaceutical industry or similar large multinational organization and proven experience of clinical development / drug development process in various phases of development and therapy areas.
• Experience from leading clinical projects and deliverables or similar expertise from other areas of drug development (such as pharmaceutical development) and proven knowledge of project management tools and processes .
• Proven leadership promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives.
• Ability to mentor, develop and educate staff .
• Excellent written and verbal communication skills, negotiation, collaboration, and interpersonal skills with ability to work effectively with others at all levels of the organization .