Global Clinical Operations Program Director, Late Development Oncology

AstraZeneca • Gaithersburg, MD

3d • Hybrid

About The Position

This role offers the opportunity to lead the operational strategy for pivotal global late-stage oncology programs (Phase 3 and post-approval). The Global Clinical Operations Program Director will translate program objectives into business-focused plans, ensuring scope, quality, budget, and timelines are met. This position involves working through a global matrix of internal experts and external partners, championing innovative delivery models, and aligning cross-functional teams around milestones and risks. The role requires shaping global study portfolios end-to-end, from country selection through submission, and coaching teams to deliver at pace and scale.

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

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

What This Job Offers

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