Global Clinical Operations Program Director, Late Development Oncology

AstraZeneca • Gaithersburg, MD

5d • $203,710 - $305,564 • Hybrid

About The Position

This role involves steering late-stage oncology programs, leading the operational strategy for pivotal global studies. The Director will translate program objectives into business-focused plans, meeting scope, quality, budget, and timelines, while championing innovative delivery models. The position requires aligning cross-functional teams around milestones and risks, and shaping global study portfolios end-to-end from country selection through submission. The role is central to a fast-moving pipeline, aiming to get medicines to patients faster and turn science into regulator-ready evidence and real-world impact.

Requirements

• Bachelors degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
• At least 10 years from within the pharmaceutical industry or similar large multinational organizations.
• Proven knowledge of project management tools and processes
• Proven experience in 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
• Proven leadership promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives
• Skilled & experienced in change management
• Ability to look for and champion more efficient and effective methods/processes of delivering clinical operations components focusing on key performance metrics around reliability, productivity, cost, and quality
• Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills with ability to work effectively with others at all levels of the organization
• Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a regional and local environment
• Integrity and high ethical standards
• Excellent stakeholder management skills
• Adaptability

Nice To Haves

• Advanced degree is preferred.
• Project management certification is desirable but not mandatory.
• Knowledge of process improvement methodology such as Lean Sigma/Change Management is desirable but not mandatory
• 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 of experts to plan and deliver a defined program of studies and clinical activities to scope, quality, budget and time, including resource planning and risk management.
• Provide strategic oversight of a program of studies on behalf of the Senior Global Clinical Operations Program Director and the Clinical Program Team.
• Provide clinical operations expertise on country selection, feasibility, operational design, risk and external partner strategy, applying innovative design and delivery models to accelerate start-up and strengthen governance interactions.
• Develop core clinical operations components for governance with oversight of the Senior GPD; contribute cost, timelines, quality, feasibility and risk inputs to new business case opportunities.
• Manage clinical plans (cost, FTEs and timelines) in business reporting systems, such as PLANIT, with clear performance targets, on behalf of the Clinical Program Team.
• Lead large or complex deliverables and proactively identify, solve or escalate operational issues; drive delivery through internal teams and external partners (alliance partners, CROs, vendors and AROs) and act as the AstraZeneca point of escalation for externally managed studies.
• Provide project leadership and management to cross-functional Clinical Submission Teams to plan and execute the clinical components of marketing applications, aligning closely with other submission contributors.
• Lead cross-functional teams in delivery of assigned Clinical Program Team activities; serve as a subject matter expert across functional and cross-functional initiatives.
• Mentor, coach and support people development, promoting motivation and empowerment to achieve individual, team and organizational objectives.
• Lead or contribute to improvement and change projects within clinical operations and beyond; be an early adopter and ambassador for new ways of working, ensuring implementation and utilization of new initiatives.
• Actively network within and outside the therapeutic area, sharing best practices and lessons learned to raise performance across programs.

Benefits

• Qualified retirement programs
• Paid time off (i.e., vacation, holiday, and leaves)
• Health, dental, and vision coverage
• Eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior