(Associate Director) Principal Clinical Pharmacologist, Cell Therapy Discovery
AstraZeneca · Guilin Road
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Role summary
AstraZeneca seeks a Principal Clinical Pharmacologist to lead pharmacology strategy development for cell therapy programs, including CAR-T and mRNA-based approaches. The role involves designing clinical studies, conducting PK/PD analyses, authoring regulatory documents, and representing the department across cross-functional teams from early research through clinical approval.
What they're looking for
- Advanced degree (MD, PhD, PharmD) in clinical pharmacology, pharmaceutical sciences, or related field
- Minimum 5 years clinical pharmacologist experience in industry, research institutions, or regulatory agencies
- Proficiency in exposure-response modeling and population-based kinetic analysis
- Expertise analyzing multi-dimensional datasets including flow cytometry and biomarkers
- Strong authoring skills for clinical study reports and regulatory submissions
- Experience with PKPD modeling tools such as NONMEM, R, WinNonlin, or SimCyp (desirable)
- Cell therapy development familiarity (desirable)
What you'll be doing
- Lead design, execution, and reporting of clinical pharmacology studies for Phase I and IIT trials, including first-in-human dose selection
- Develop and align short-to-medium-term clinical pharmacology plans across cell therapy assets and development stages
- Author and finalize study protocols, Investigator's Brochures, and Clinical Study Reports while managing CRO partners
- Perform advanced PK/PD analyses using non-compartmental and population modeling methods to define risk-benefit profiles
- Serve as independent clinical pharmacology lead and subject-matter expert on cross-functional development teams
Privacy & handoff
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