Evidence Delivery Associate Director, CL E.

Introduction to role

Are you ready to take on a pivotal role that requires deep expertise in your field? As an Evidence Delivery Associate Director, you'll be recognized as a specialist, working independently with minimal guidance. You'll tackle complex problems with innovative solutions and may even coach or lead teams of technicians or scientists. This is your chance to make a significant impact!

Accountabilities

- Plan and lead the delivery of all components of a clinical development project.
- Act as leader of the clinical development team, ensuring consistency and oversight throughout the project lifecycle.
- Develop recruitment strategies and ensure the delivery of approved Clinical Development Protocols.
- Collaborate with Line Managers to identify and secure resources from various departments for the timely formation of Clinical Study Teams and progression of deliverables.
- Forecast and manage timelines, budgets, materials, project plans, and feasibility assessments on a day-to-day basis.
- Lead and implement globally agreed Clinical Development strategies, including process and technology initiatives.
- Plan and lead activities associated with audits in liaison with CQA; contribute to regulatory inspection strategy teams as required.
- Develop and manage contingency risk plans to assure timely delivery within quality standards, budget, and timelines; escalate issues to stakeholders as appropriate.
- Lead the preparation and delivery of clinical development deliverables.
- Establish and maintain key interactions with stakeholders.
- Plan, lead, and ensure appropriate training at Investigator and monitor meetings.
- Coordinate and contribute to the timely delivery of Study Delivery components of submissions to regulatory authorities (e.g., CSRs, CTDs, INDs, IND annual reports).
- Lead and optimize the performance of study delivery teams, ensuring GCP compliance; provide timely and accurate performance feedback for study team members to skill center managers.
- Foster a culture of courageous leadership, creativity, and collaboration.

Essential Skills/Experience

- 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 Skills/Experience

- 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.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we are at the forefront of shaping the future of healthcare. Our unique position as medical leaders allows us to drive innovation that truly impacts patients' lives. With endless opportunities for growth, we thrive on collaboration across our enterprise. Our commitment to developing groundbreaking medicines is unwavering, making this an inspiring place to advance your career.

Ready to make a difference? Apply now to join our dynamic team!