SUMMARY OF THE ROLE The Bioanalysis and Translational Medicine department centers on data‑driven bioanalysis and translational research, leveraging molecular/protein assays, cellular function and phenotyping, and biomarker with PK/PD platforms to support cell therapy programs including ex vivo and in vivo CAR‑T, and other programs (i.e.TCE program). The Cell Therapy Clinical Pharmacologist leads the development and execution of pharmacology strategies for novel cell therapy, independently representing the department across clinical study and project teams. By applying quantitative principles to cellular kinetics and pharmacodynamics, the individual bridges early research and clinical application to optimize dosing and minimize unique toxicities like CRS. This role requires rigorous cross-functional collaboration to design, interpret, and report key studies—including first-in-human and drug interaction trials—ensuring the efficient advancement of drug candidates through regulatory approval. ROLE & RESPONSIBILITIES · Lead the design, execution, and reporting of Clinical Pharmacology (CP) studies for IIT/Phase I clinical trials, including First-in-Human dose selection and Go/No-Go decision-making. · Develop and align short-to-medium-term CP plans for assets across all development stages, ensuring integration with broader program goals. · Author and finalize core clinical documents—including study protocols, Investigator’s Brochures (IB), and Clinical Study Reports (CSR)—while managing CROs to ensure high-quality execution. · Perform advanced pharmacokinetic/pharmacodynamic (PK/PD) analyses using non-compartmental methods, population modeling, and exposure-response simulations to define risk/benefit profiles. · Synthesize and communicate PK/PD results and their clinical implications to study teams and senior leadership in a timely, actionable manner. · Serve as the CP lead on cross-functional clinical development teams, acting as the primary subject-matter expert for internal stakeholders and external partners. · Lead the preparation of regulatory briefing documents and represent the project team as the CP expert in formal interactions with health agencies. · Drive the establishment of departmental best practices, including the creation of SOPs, quality systems, and standardized report templates to support a growing team. REQUIREMENTS Essential: Advanced degree (MD, MD/PhD, PhD or PharmD, Master’s with equivalent experience is preferred) in clinical pharmacology, pharmaceutical sciences or related fields such as pharmacokinetics, pharmacology or drug metabolism Minimum of 2 years of experience working as a clinical pharmacologist in pharmaceutical industry, research institutions and/or regulatory agencies, with a strong track record in designing, interpreting, and reporting clinical pharmacology studies Skills & Capabilities Familiarity with standard exposure-response concepts and pharmacokinetic principles. Experience contributing to clinical study documents, such as clinical study protocols or clinical study reports (CSRs). Ability to work effectively within multidisciplinary study teams and manage day-to-day study timelines. Strong written and verbal English communication skills, with the ability to collaborate effectively across global matrix teams. Desirable: Hands-on experience with standard PK/PD software tools (e.g., Phoenix WinNonlin, R, or NONMEM) Exposure to advanced modeling techniques like population PK/PD or PBPK modeling. General familiarity with the broader drug development process, particularly for novel modalities like Bi-specific Antibody, T cell engager, cell therapy etc. Experience handling or interpreting biomarker data (e.g., cytokines or flow cytometry). Strong interpersonal, organizational, and communication skills; able to work independently and effectively within a collaborative matrix team environment Date Posted 22-10月-2026 Closing Date 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. 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.

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