Senior Global Clinical Operations Program Director

AstraZeneca•South San Francisco, CA

6d•Hybrid

About The Position

As a Senior Global Clinical Operations Program Director, you will guide the operational delivery of an ambitious clinical development plan, translating strategy into measurable outcomes that matter for patients and the business. You will be a core leader on the Clinical Program Team, partnering across disciplines to enhance the scientific and clinical relevance of our cell therapy assets. In this role, you will integrate strategy, build, feasibility, and operational planning to deliver programs within defined parameters of scope, quality, budget, and schedule. You will build clinical program structures, champion creative approaches to compose and implementation, and ensure robust governance. This is your opportunity to influence direction at scale while developing high-performing teams and trusted partnerships that drive value.

Requirements

Bachelor of Science/Master of Science degree in related field, or equivalent work 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 Cell Therapy development and ideally across multiple therapeutic areas
Clinical operations knowledge with strong track record of delivery
Extensive knowledge of the clinical and pharmaceutical drug development process
Validated 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 collaborators and external partners
Strong strategic influencing skills: ability to influence broadly within and outside the organisation
Excellent written and verbal communication skills
Proven collaboration and ability to work collaboratively across a wide range of teams
Track record of planning, prioritisation and delivery success
Willingness to travel both domestic and international

Nice To Haves

Advanced degree is preferred
Demonstrated ability to drive process improvement and/or functional work
Cell Therapy Study Management Experience in a pharma/biotech setting
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

Lead end-to-end oversight of clinical program activities, advancing relevant issues to senior governance and providing clinical operations expertise in feasibility, country selection, operational input to design, risk management, and external partner management.
Use innovative design and delivery models to accelerate project start-up and informed decision-making.
Partner with the Global Clinical Head and the Biometrics Team Leader to set clear direction and shared goals for Clinical Program Team members and clinical delivery teams, ensuring cohesive execution.
Manage all clinical development deliverables to scope, quality, budget, and time.
Drive program strategy, study design, resourcing, and risk mitigation that translate into predictable delivery and business impact.
Establish team structures, governance, and ways of working that enable a high-performing Clinical Program Team focused on outcomes and continuous improvement.
Provide line management to global clinical operational leaders at the study and program levels, including Global Study Associate Directors or Global Study Directors and Global Program Directors aligned to the product team’s deliverables.
Serve as the line manager for Global Study Directors within your aligned product team.
Own the clinical operations components of regulatory submissions, support regulatory interactions and reporting, and lead clinical contributions to inspection readiness for marketing applications and post-registration maintenance.
Act as the initial and program-level operational work with outsourced partners (CROs/AROs) and collaboration/alliance partners.
Serve as AstraZeneca’s decision maker and critical issue point to ensure contract partners deliver to expectations.
Ensure timely compliance with company-wide governance controls, including financial oversight, planning and control, continuous assurance, and Clinical Trial Disclosure.
Manage clinical plans—cost, FTEs, and timelines—in business reporting systems such as PLANIT.
Lead or contribute to non-drug project work and cross-functional improvement initiatives.
Be an early adopter and ambassador for new ways of working, contribute as a Subject Matter Expert, mentor and coach colleagues, and actively network to share standard methodologies and takeaways.

Benefits

AstraZeneca is dedicated to being a Great Place to Work.
Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit.
To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges.
An inclusive culture where you will connect different thinking to generate new and valuable opportunities.
A commitment to lifelong learning, growth and development for all.
Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking.
We’re curious about science and the advancement of knowledge.
We find creative ways to approach new challenges.
We’re driven to make the right choices and be accountable for our actions.
As an organisation centred around what makes us human, we put a big focus on people.
Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab.
Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential.
Here, you’ll do work that has the potential to change your life and improve countless others.
And, together with your team, you’ll shape a culture that unites and inspires us every day.