(Associate Director) Principal Clinical Pharmacologist, Cell Therapy Discovery

SUMMARY OF THE ROLE

The Bioanalysis and Translational Medicine department centers on datadriven bioanalysis and translational researchleveragingmolecular/protein assays cellular function and phenotyping and biomarker with PK/PD platforms to support cell therapy programs including CART and mRNALNP/lentiviral in vivo CAR.

The Cell Therapy Clinical Pharmacologist leads the development and execution of pharmacology strategies for novelcell therapyindependentlyrepresentingthe department across clinical study and project teams. By applying quantitative principles to cellular kinetics and pharmacodynamics the individual bridges early research and clinical application tooptimizedosing and minimize unique toxicities like CRS. This role requires rigorous cross-functional collaboration to design interpret andreportkey studiesincluding first-in-human and drug interaction trialsensuring 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 Iclinical 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 andfinalizecore clinical documentsincluding study protocols Investigators 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 ina 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/PhDPhDor PharmD) in clinical pharmacology pharmaceutical sciences or related fields such as pharmacokineticspharmacologyor drug metabolism

• Minimum of5years of experience working as a clinical pharmacologist in pharmaceutical industry researchinstitutionsand/or regulatory agencies with a strongtrack recordin designing interpreting and reporting clinical pharmacology studies

Skills & Capabilities

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

• Expertisein analyzing large multi-dimensional datasets including flow cytometry cytokines and molecular biomarkers.

• Utilizationof AI forthe analysis and predictivemodels.

• 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:

• Deepexpertisein pharmacokinetic/pharmacodynamics drug metabolism drug-drug interactions and population PKPD and PBPK modelling with hands-on experience using tools such as NONMEM RWinNonlin andSimCyp

• Broad familiarity with the drug development process particularly forcell 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 soundjudgements adapt to changing business needs and manage multiple priorities in complex settings

• ExcellentEnglishcommunication skills including cross-cultural collaboration and compelling scientific and program presentations