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 CAR‑T and mRNA‑LNP/lentiviral in vivo CAR.  

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 complex PK/PD results and their clinical implications to study teams and senior leadership in a timely, actionable manner. 

• Serve as the independent 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) in clinical pharmacology, pharmaceutical sciences or related fields such as pharmacokinetics, pharmacology or drug metabolism 

• Minimum of 5 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 

• Ability to perform complex exposure-response and population-based kinetic modeling. 

• Expertise in analyzing large, multi-dimensional datasets including flow cytometry, cytokines, and molecular biomarkers. 

• Utilization of AI for the analysis and predictive models. 

• Strong ability to author high-quality clinical study reports (CSRs) and regulatory submissions. 

• Capability to lead multidisciplinary study teams and manage multiple clinical programs simultaneously. 

Desirable: 

• Deep expertise in pharmacokinetic/pharmacodynamics, drug metabolism, drug-drug interactions, and population PKPD and PBPK modelling, with hands-on experience using tools such as NONMEM, R, WinNonlin, and SimCyp 

• Broad familiarity with the drug development process, particularly for cell therapy, is highly desirable  

• Strong interpersonal, organizational, and communication skills; able to work independently and effectively within a collaborative matrix team environment 

• Ability to make sound judgements, adapt to changing business needs, and manage multiple priorities in complex settings 

• Excellent English communication skills, including cross-cultural collaboration and compelling scientific and program presentations