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Global Clinical Operations Program Director

AstraZeneca PLC
10 hours ago
Full-time
On-site
US - South San Francisco - CA
Clinical Research and Development
At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.  Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.    Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.  Introduction to role The Global Clinical Operations Program Director (GPD) is a core global role within the Cell Therapy Clinical Operations (CTCO) function. The span of responsibilities is broad and may support one or several products depending on scope and complexity. The products supported will be in Phase 1-3 development, but the program may include studies in all phases of drug development. On behalf of the Senior Global Clinical Operations Program Director (Sr GPD), the GPD provides strategic operational leadership and oversight of a suite of global clinical studies within a program covering all clinical program deliverables, covering all clinical operations deliverables to scope, quality, budget, time, resource, and risk, ensuring new innovative design and delivery models are used appropriately. The role involves integrating strategy, design, feasibility and operational planning to produce business-focused clinical drug development programs that align with priorities and strategy. The GPD will develop the core clinical operations components for governance interactions with the oversight of the Sr GPD. The GPD may also act as the lead for cross-functional teams in delivery of clinical program team (CPT) activities assigned. The GPD may provide project leadership for cross-functional clinical submission teams in support of regulatory marketing applications and post-registration product maintenance deliverables. Additionally, the GPD may lead or contribute to improvement and change projects within clinical operations and/or other business areas. Accountabilities: Lead cross-functional teams of experts in the planning and delivery of a defined clinical program of studies and/or clinical activities to scope, quality, budget, time, planning the resource and managing risk Work closely with global study leaders to provide appropriate strategic oversight of a program of studies on behalf of Sr GPD and Clinical Program Team (CPT) Provide clinical operations expertise into the project (e.g. country selection, feasibility, operational input into design, risks and external partner management) using new innovative design and delivery models to support governance interactions and project start-up. Responsible for providing clinical operations expertise into the development of new business case opportunities for review by governance bodies (cost, timelines, quality, feasibility, risk) On behalf of CPT, responsible for managing clinical plans (cost, FTEs and timelines) in business reporting system, such as PLANIT Lead large or complex deliverables and the process to identify and solve/escalate operational issues and drive delivery to plan through internal or external partners (Alliance partners, Clinical Research Organizations (CROs), vendors and Academic Research Organizations (AROs)). Act as the AZ point of escalation for study teams for external (e.g. CRO) partners for externally managed/outsourced studies as appropriate Responsible for leadership and program management of non-drug project work as assigned, e.g. cross functional improvement/change initiatives Provide project leadership & management to cross functional Clinical Submission Teams in planning and execution of clinical contribution to Marketing Applications (aligning closely with other key contributors to submission package) Lead cross-functional teams in delivery of assigned clinical program team (CPT) activities Contribute to functional and cross-functional initiatives as Subject Matter Experts Mentor, coach and support people development as appropriate. Actively participate in networking both within and outside the therapeutic area, sharing best practises and lesson learnt Be an early adopter for new ways of working and act as ambassadors for change, driving the implementation and utilization of new initiatives. Essential skills/experience: Minimum of university degree (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 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 Desirable skills/experience: Project management certification is desirable but not mandatory. Cell Therapy Study Management Experience in a pharma/biotech setting 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 Where can I find out more? Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/ Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/ Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en Our US Footprint: Powering Scientific Innovation - YouTube The annual base pay (or hourly rate of compensation) for this position ranges from $171,622.40 to 257,433.60 USD. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com. AstraZeneca offers an environment where you can be empowered to make bold decisions and move at pace. With a focus on Oncology, we are driven by speed and backed by leadership that empowers every level to prioritize smart risks based on scientific evidence. Our scale, agility, and passion ensure fast delivery every time. Join us in pioneering new frontiers in cancer research, where courage, curiosity, and collaboration drive patient outcomes. Be part of a team committed to improving the lives of millions with cancer. Ready to take on this exciting challenge? Apply now to join our dynamic team! #LI-Hybrid Date Posted 07-Apr-2026 Closing Date 19-Apr-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re 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. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. 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. This is your life at AstraZeneca.