Associate Director, Clinical Pharmacology

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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Associate Director, The Clinical Pharmacology (CP) Expert Team Lead (CPET-Lead) position in Quantitative Pharmacology (QP) within broader Clinical Measurement Sciences (CMS) organization will be scientific and strategic cross-functional lead role, responsible for developing and executing the QP strategies including model-informed drug development (MDD) from the early translational to the late-stage clinical development in cross functional drug discovery and development project teams in close collaboration with colleagues in Clinical Development, Biostatistics, Data Sciences, Clinical Biomarkers and Diagnostics, Research, and other colleagues within the R&D organization.

The ultimate aim is to develop the right medicine with the right dosage (level, regimen and adjustments with different conditions and specific populations) and right drug combinations for ALL patients and to provide health authorities and prescribers with appropriate information.

CP Expert Team Lead is a strategic, scientific and cross-functional role, leading an Expert Team. This team comprises subject-matter experts (SME) from CP, Pharmacometrics (PMx), clinical PK (CPK), Translational Quantitative Pharmacology (TQP), and Clinical Biomarker & Companion Diagnostics (CBD), Drug Metabolism and Pharmacokinetics (DMPK), and, on an ad-hoc basis, other functions (e.g. Chemical Preclinical Safety (CPS), Global Clinical Development (GCD), Global Clinical Operation (GCO), Global Biostatistics, Medical writing and Epidemiology (GBEM), Global Product Safety (GPS), Global Regulatory (GRA), Business franchises for life cycle management (LCM)).

This role represents the CP Expert Team to the clinical team (CTT) and Global Project Team (GPT).

The CP Expert Team Lead provides strong leadership for integrating individual functional contributions, developing CP translational strategy in alignment with the overall clinical development plan, seeking the endorsement from management, and executing the program strategy/plan according to appropriate timeline.

• The approach includes, but is not limited to, translation from bench to bedside and reverse translation back to the bench, knowledge transferring from literature or external collaboration to internal programs, with regarding to pharmacokinetics, pharmacodynamics, disease progression, relevant covariates (such as baseline disease, target, and pathway) and posology/dosage aiming to move the program to the next stage leading to regulatory submissions and LCM or an early termination with speed, efficiency and innovation based on data and model informed drug development (MIDD) approach in close collaboration with the experts on the team.
• The scope includes the internal programs from exploratory development (ED) through life cycle management, and relevant external collaboration programs of all stages related to CP discipline, encompassing large and small molecule therapeutics/drug…