Evidence Delivery Associate Director, CL E.

Typical Accountabilities

• Plan and leadthe delivery of all components of a clinical development project.
• Act as leaderof the clinical development team, ensuring consistency and oversight throughout the project lifecycle.
• Develop recruitment strategiesand ensure the delivery of approved Clinical Development Protocols.
• Collaborate with Line Managersto identify and secure resources from various departments for the timely formation of Clinical Study Teams and progression of deliverables.
• Forecast and managetimelines, budgets, materials, project plans, and feasibility assessments on a day-to-day basis.
• Lead and implementglobally agreed Clinical Development strategies, including process and technology initiatives.
• Plan and leadactivities associated with audits in liaison with CQA; contribute to regulatory inspection strategy teams as required.
• Develop and managecontingency risk plans to assure timely delivery within quality standards, budget, and timelines; escalate issues to stakeholders as appropriate.
• Lead the preparation and deliveryof clinical development deliverables.
• Establish and maintainkey interactions with stakeholders.
• Plan, lead, and ensureappropriate training at Investigator and monitor meetings.

• Coordinate and contributeto the timely delivery of Study Delivery components of submissions to regulatory authorities (e.g., CSRs, CTDs, INDs, IND annual reports).

• Lead and optimizethe performance of study delivery teams, ensuring GCP compliance; provide timely and accurate performance feedback for study team members to skill center managers.
• Foster a cultureof courageous leadership, creativity, and collaboration.

Global Remit

• The role operates ina minimum of 2 or 3 countries, accounting for at least 40% of the time.

Education, Qualifications, Skills and Experience

Essential

• Bachelor’s degree in biological science or healthcare-related field.
• Experience in the pharmaceutical industry, specifically in clinical study delivery or clinical development processes.
• Demonstrated leadership ability in a team environment.
• Experience with project management methodologies.
• Advanced knowledge of clinical study and drug development processes and GCP/ICH guidelines.
• Excellent written and verbal communication skills, with proven negotiation, collaboration, and interpersonal leadership abilities.
• Experience in budgetary and resource management planning.
• Willingness to travel domestically and internationally.
• Fluent in spoken and written English.
• Team oriented, flexible, and able to respond quickly to shifting demands and opportunities.

Desirable

• Proven ability to plan, coordinate, and facilitate delivery of team objectives.
• Demonstrated project management skills and operational expertise in risk management and contingency planning.
• Solid understanding of disease states and familiarity with current research and thought leadership.
• Extensive knowledge of clinical study/drug development processes, GCP/ICH guidelines, and SOPs.
• Ability to understand the impact of technology on projects and to use/develop relevant computer skills, with proficiency in AZ and Study Delivery systems/software.
• Conceptual, analytical, and strategic thinker.
• Effective at problem solving and conflict resolution; demonstrated team focus and cooperation.
• Willingness to learn from others and share relevant information for team success.

Key Relationships

Internal (within AZ)

• Study Delivery personnel

• Data Management Centre representatives
• Clinical Project Team and therapy area personnel
• Clinical Development personnel
• Clinical Pharmacology Units
• Study Site personnel
• Regional Monitoring personnel
• Other Skill Centres as appropriate

External (to AZ)

• External service providers
• Marketing Company personnel