The Senior Translational & Precision Medicine Leader (STPML) is accountable for the development and implementation of Translational & Precision Medicine (TPM) strategy and deployment of invovative research approaches to enhance the probability of success of clinical programs in the assigned therapeutic areas (TA).
The STPML will lead a cross-functional TPM Expert Team(s) in a matrix environment and will be responsible for the planning, design, execution, and data interpretation of translational and precision medicine studies, across all phases of drug development, in accordance with Teva strategy and priorities, including timely composition of study reports and other relevant documentation. In addition, the STPML will lead biomarker discovery and development research initiatives associating molecular, histologic, radiographic, physiologic and digital biomarkers with drug response, safety and/or compliance.
How you’ll spend your day:
Oversees the development and implementation of an overarching TPM strategy for the portfolio of Teva Innovative programs/products within the assigned therapeutic areas (TAs), in all phases of clinical development, from the translational and precision medicine perspective (from first in man through post-approval), translating relevant Target Product Profile (TPP) attributes into clinical studies/evaluations required to achieve the target label.
Prepares and manages TPM Plans to enhance probability of success for all clinical programs in collaboration with relevant functions.
Functions independently and leads a cross-functional TPM Expert Team(s) in a matrix environment.
Leads the selection, planning, design, execution, and data interpretation of TPM studies (including Phase 0, 1b, proof of concept, window of opportunity, surrogate biomarkers and intermediate clinical enspoints, etc.) with scientific rigor and innovative approaches.
Leads biomarker discovery and development research initiatives associating molecular, histologic, radiographic, physiologic or digital biomarkers with drug response, safety and/or compliance.
Advises TA and other relevant R&D functions as an expert in all TPM related aspects of science, medicine, regulatory strategy, intellectual property (IP), assay development, commercial value, etc. Provides expert support to the evaluation of in-licensing compound and collaboration opportunities as needed.
Works closely in collaboration with TA leadership to enhance a candidate selection and to develop comprehensive TPM scientific (de-risking) plans for each of the prioritized candidates selected to move into the clinic. Ensures these plans are developed throughout the life cycle of the compound and assumes the responsibility for updating templates for the plans as needed by the changing priorities within the company.
Oversees the design of programmatic translational strategies and study-specific biomarker studies, composing the relevant documentation and being accountable for its on-time execution. Provides support to TPMLs as they encounter unexpected issues, obstacles and challenges to the successful implementation of TM strategies within TAs.
Works with outside departments to ensure collaboration and selection of cost-effective and appropriately validated assays, delivered on time in relevant programs. Guides TPMLs on the development of backup and contingency plans as needed.
Assesses providers and ensures the availability and subscription to tools and databases that enable rapid access to relevant in silico data from a wide variety of external sources for internal decision making, to inform biomarker strategies and facilitates interpretation of results.
Aligns with Biostatistics on statistical analysis plan (SAP) templates, tools and data analytical approaches and ensures co-development of the SAP, or equivalent, of TPM programs within and parallel to the clinical program for all relevant programs at Teva.
Evaluates data sets from Biostatistics, employs tools and literature review to interpret the biological relevance, and presents final assessments to clinical and core teams along with specific recommendations related to TPM-influenced decision making for the program.