Senior Global Clinical Operations Program Director, Late Development Oncology

AstraZeneca • Gaithersburg, MD

3d • $233,586 - $350,380 • Hybrid

About The Position

This core global role within the Clinical Operations function of Late Stage R&D is accountable to the Global Product Team (GPT) for the operational delivery of the agreed clinical development plan. As a Sr GPD, you will be responsible for program leadership and management of all clinical operations deliverables to scope, quality, budget, time, resource and risk, ensuring new innovative design and delivery models are used appropriately.

Requirements

• Bachelor of Science/Master of Science degree in related discipline, or equivalent work experience. Advanced degree is preferred
• 12 years of relevant experience
• Extensive global drug development leadership or equivalent leadership experience demonstrated in a variety of roles.
• Extensive experience across the product life cycle with experience in late stage development and ideally across multiple therapeutic areas
• Clinical operations knowledge with strong track record of delivery
• Comprehensive knowledge of the clinical and pharmaceutical drug development process
• Proven ability to develop programs to meet business goals and to assess business risk versus potential value; ability to understand global business requirements
• Significant experience of program management and use of project management techniques in complex projects, including resourcing, financial management and business case development
• Proven ability to develop successful collaborations with internal stakeholders and external partners
• Strong strategic influencing skills: ability to influence broadly within and outside the organisation
• Excellent written and verbal communication skills
• Proven teamwork and ability to work collaboratively across a wide range of disciplines
• Track record of planning, prioritisation and delivery success
• Willingness to travel both domestic and international

Nice To Haves

• Demonstrated ability to drive process improvement and/or functional work
• Experience of implementing changes in ways of working that focus on increasing efficiency
• Regulatory submission experience
• Previous success of working in Japan and China to ensure delivery of global programmes to meet business needs
• Proven experience in leading teams through change
• Experience of and insight into the Clinical environment to be able to drive major improvement programs
• Experience in line management of leadership roles

Responsibilities

• Oversight of all clinical program activities, ensuring relevant issues are escalated to GPT.
• Partner effectively with the Global Clinical Head (GCH) and the Biometrics Team Leader to provide leadership, clear direction and aligned goals to the CPT members/clinical delivery teams.
• Establishing team structure and ways of working to ensure CPT is a high performing team.
• Accountable for the clinical operations component deliverables of regulatory submissions, providing support for regulatory interactions and reports and clinical contributions to inspection readiness.

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

What This Job Offers

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