Director Clinical Trial Start Up - Cell Therapy

Do you have deep expertise in and passion for clinical operations leadership and study start-up? Would you like to apply your people leadership skills  and clinical operations experience to impact the delivery of next‑generation cellular therapy clinical trials across APAC in a company that follows the science and turns ideas into life‑changing medicines? Then AstraZeneca might be the one for you!

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in four therapy areas – Oncology; Cardiovascular, Renal and Metabolism (CVRM); Respiratory & Immunology (R&I); and Rare Disease.

At AstraZeneca Australia, we have been working to deliver the best value to patients for more than 60 years, and we push the boundaries of science to deliver life-changing medicines.

Within Oncology R&D, AstraZeneca is investing in our internal capabilities to help us realise our ambition to become leaders in developing next-generation cellular therapies. Leveraging historical expertise in biologics engineering, gene editing and immunology across solid and haematological malignancies, we are uniquely positioned to develop cutting-edge technologies to advance cell therapies in cancer treatment.

We are recruiting new clinical study team members and supporting teams based in Australia, to support our clinical trials as we work towards the next generation of cell therapies

What you’ll do

Lead the regional Cell Therapy Start-Up Site Monitoring and Management (SMM) function to deliver interventional clinical studies across Australia, Korea, Taiwan and Singapore. You will line-manage study start-up managers and contract managers. You will handle regional budget management and contract signatory duties. You will also drive audit preparedness and site activation with speed and quality. This role supports building an engaged team at the ground level of AstraZeneca’s rapidly growing Cell Therapy portfolio.

Reporting to the Director responsible for Global Cell Therapy SMM, this new full-time permanent role can be based in Sydney or Melbourne. There is a preference for the Sydney location and hybrid working with 3 days in the office. The role will be part of the Cell Therapy clinical study leadership team.

Key Responsibilities:

• Lead and develop the Cell Therapy SMM team: build engagement, coach line reports, ensure adequate resources and high performance across start‑up and contracting; support development and performance management.

• Own regional budgets, contracts and approvals: oversee country budgets, site/vendor payments and POs; act as signatory for site budgets and contracts; escalate and resolve complex budget/contract issues; deliver regional/country budgets to plan.

• Drive feasibility, enrolment and activation: contribute to high‑quality feasibility and deliver established country enrolment projections; ensure regulatory submissions/approvals; maintain “inspection‑ready” standards and keep all operational systems continuously and accurately updated (including TMF completeness).

• Partner across functions and vendors: collaborate with Study Management, LSMs, Legal, Medical Affairs, Field Clinical Advisors, CROs and vendors to remove bottlenecks and optimise patient outcomes—including oversight of end‑to‑end chain of custody between clinical sites, manufacturing, apheresis and back to patient care.

• Model digital and process innovation: support local implementation of AZ’s digital strategy, champion continuous improvement and adopt technology/AI‑enabled ways of working.

• Manage risk and performance communication: provide clear updates to the Global Head SMM on feasibility, enrolment, risks and mitigations; assist Local Study Managers/teams on feasibility, forecasting timelines/resources/materials and resolving key issues, ensuring country‑level compliance with local policies, code of ethics and ICH‑GCP.

Essential for the role

• Bachelor’s degree in life science or related discipline (or equivalent)

• 7+ years’ leadership experience in Development Operations/clinical operations; regional experience highly regarded

• Proven line management and team development experience with strong project management and resource/financial management skills.

• Extensive clinical operations expertise including study start‑up, feasibility, regulatory submissions, and budget/contract negotiation at country/site level.

• Excellent negotiation, influencing and communication skills with the ability to build strong partnerships and make sound decisions in cross‑functional settings.

• Strong knowledge of ICH‑GCP and relevant local regulations; ability to ensure inspection readiness and compliant systems/processes.

• Ability to work across dispersed teams with national/international travel as required; fluent written and spoken English.

Desirable for the role

• Experience in CAR therapies and deep understanding of SMM/monitoring processes.

• Knowledge of GMP/GDP and study drug handling/data management processes.

• Strong intercultural awareness and crisis management capability in international studies.

• Track record of process improvement and adoption of digital/AI-enabled clinical operations.

• Experience partnering with CROs/vendors and operating to global standards in a hybrid/remote environment.

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next!

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

• Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

Where can I find out more?

Follow AstraZeneca on LinkedIn:  https://www.linkedin.com/company/1603/

Visit our website: www.astrazeneca.com.au and our cell therapy careers page: https://careers.astrazeneca.com/cell-therapy

AstraZeneca in Australia has been formally recognised as an Employer of Choice for Gender Equality by the Workplace Gender Equality Agency (WGEA) and as a Gold Tier Employer within the Australian Workplace Equality Index (AWEI). Visit our ANZ Careers Page - www.astrazeneca.com.au/careers.html  to learn more about our commitment to fostering a flexible, diverse, and inclusive environment.

We recognise that any recruitment process may present challenges, if there is anything we can do to make our recruitment process more accessible for you, please let us know via this Form.

Date Posted

23-Jan-2026

Closing Date

22-Feb-2026

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.