Global Operations Program Director

AstraZeneca • Gaithersburg, MD

91d

About The Position

As a Global Clinical Operations Program Director (GPD), you'll play a pivotal role in leading all aspects of global clinical studies, ensuring they meet scope, quality, budget, and time requirements. Your expertise will drive innovative design and delivery models, aligning clinical drug development programs with strategic priorities. You'll lead cross-functional teams, contribute to regulatory submissions, and spearhead improvement projects. This is your chance to make a significant impact on the future of medicine!

Requirements

• BS or equivalent, preferably in medical or biological sciences or discipline associated with clinical research.
• Advanced degree is preferred.
• At least 10 years' experience from within the pharmaceutical industry or similar large multinational organization.
• Proven knowledge of project management tools and processes.
• Proven experience of clinical development / drug development process in various phases of development and therapy areas.
• Proven ability to learn by working in multiple phases, TAs and/or different development situations.
• Experience from leading clinical projects and deliverables or similar expertise from other areas of drug development (such as pharmaceutical development).
• Ability to mentor, develop and educate staff.

Nice To Haves

• Project management certification.
• Knowledge of process improvement methodology such as Lean Sigma/Change Management.
• Regulatory submission experience.
• Proven knowledge of clinical operations.
• Experience with development and implementation of digital health initiatives in Clinical Studies.

Responsibilities

• Lead cross-functional teams in planning and delivering clinical programs to scope, quality, budget, and time.
• Provide strategic oversight for global study leaders on behalf of Sr GPD and Clinical Program Team (CPT).
• Offer clinical operations expertise into project design, feasibility, and risk management using innovative models.
• Develop new case opportunities for governance review.
• Lead Clinical Submission Teams for marketing applications and regulatory interactions.
• Drive large or complex deliverables, solving operational issues and ensuring delivery through partners.
• Manage clinical plans in business reporting systems like PLANIT.
• Act as AZ point of escalation for study teams with external partners.
• Lead non-drug project work and cross-functional improvement initiatives.
• Mentor and support staff development.
• Participate in networking and exchange guidelines within and outside therapeutic areas.
• Support new ways of working and motivate change initiatives.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree