Senior Scientist/Associate Principal Scientist, Cell Therapy Clinical Pharmacologist Full-time NEW

Bioanalysis And Translational Medicine Department 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

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.