The opportunity
Teva's R&D Global Early Clinical Development is hiring for a Senior Translational & Precision Medicine Leader (STPML) – Immunology in the Translational and Precision Medicine (TPM) group who will be accountable for the development and implementation of the overarching TPM strategy and deployment of innovative research approaches to enhance the probability of success of drug asset programs in the Immunology therapeutic areas (TA).
The STPML will lead a matrix TPM Immunology TA Team and oversee testing of translational science hypothesis, generation of decisional evidence and insights, development of clinical biomarkers, as well as experimental and precision clinical development. This role will work in close collaboration with various discovery, preclinical and clinical development functions to identify opportunities for enhancing the selection of new drug candidates and for the candidates to move quickly into the late stage of clinical development.
Travel Requirements: Approximately 10-20% – presentations and/or attendance at 2 or more domestic and/or 1 or more domestic + 1 international scientific association meeting per year, plus key opinion leaders, scientific advisory boards regulatory meetings, academic collaborations, consortia, and other strategic meetings as required.
How you’ll spend your day
The Senior Translational & Precision Medicine Leader (STPML) oversees the provision of the TPM support to drug asset programs by enhancing the probability of success and de-risking the development of candidates in all phases of clinical development from first in human (FIH) through post-approval.
The STPML is accountable for the development and execution of the overarching TPM Strategy for the Immunology TA drug asset portfolio in accordance with Teva priorities.
Leads a matrix TPM Immunology TA Team consisting of Translational Science, Clinical Biomarker, and Precision Medicine scientists and physicians. Ensures regular portfolio reviews, proactively identifies issues, obstacles, and challenges, and develops contingency plans.
Oversees generation and evaluation of scientific and clinical insights that contribute to the characterization of the drug target, guide indication selection, identify targeted patient populations, support rational drug combinations, and inform mechanisms of action and resistance.
Oversees biomarker development and research initiatives, including association of molecular, histologic, radiographic, physiologic, and digital biomarkers with drug response, safety and/or compliance.
Oversees the design, planning, execution, medical monitoring, and interpretation of Experimental and Precision Medicine clinical studies (including Phase 0, Phase 1b, proof of activity and concept, adaptive, master protocol, and window of opportunity studies) and ensures that clinical studies are conducted with scientific rigor, comply with the highest ethical and safety standards and are compliant with clinical, ICH and GCP guidelines, and Teva’s SOPs.
Oversees identification and validation of novel endpoints for early decision making and patient or target population stratification strategies to support rapid demonstration of safety and efficacy (surrogate biomarkers, intermediate clinical endpoints, digital COAs).
Oversees design of experiments and studies, analysis and interpretation of data, writing of study reports, summary of key findings, and communication of insights and recommendations to the Immunology TA leadership and relevant R&D functions.
Oversees TPM regulatory engagements and submissions and interacts with regulatory inspectors and auditors.
Collaborates with various discovery, preclinical and clinical development functions to identify opportunities for enhancing the selection of new drug candidates and for the candidates to move quickly into the late stage of clinical development.
As a member of the TA Strategy Team (TAST), provides input and shapes the Innovative Medicine strategy for Immunology.
Advises Immunology TA leadership and other relevant R&D functions as an expert in all TPM related aspects of science, medicine, regulatory strategy, intellectual property (IP), commercial value, etc.
Provides expert support to the evaluation of in-licensing and collaboration opportunities.
Develops the TPM Scientific Engagement and Publication Strategy and oversees the preparation of presentations, abstracts, and scientific publications. Presents at international conferences and to internal and external audiences.
Fosters collaborative relationships and leads discussions with external subject matter experts, academic collaborators, patient advocacy groups, and commercial suppliers and vendors.
