Teva Director Translational Science Lead - Immunology 

United States, New Jersey 

843823529

Travel Requirements: Approximately 10 -15% - presentations and/or attendance at approximately 2 domestic and/or 1 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.

Essential Duties & Responsibilities:

• The Translational Science Lead (TSL) supports 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 TSL is responsible for the development and execution of the Translational Science Plan and for providing scientific input into the Clinical Biomarker Plan as well as an overarching Translational and Precision Medicine (TPM) Strategy for the assigned Immunology therapeutic area (TA) drug asset(s) in accordance with Teva priorities.
• Leads 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.
• Stays current on relevant scientific/technical literature and competitive intelligence in order to apply external knowledge to internal research programs.
• Oversees the development and maintenance of the Translational Science Knowledge Dossier.
• Leads a cross-functional TPM Project Team(s) in a matrix environment, provides translational science guidance to core project teams, participates in discussions with clinical development teams, functional teams, and other relevant multi-disciplinary teams and governing bodies.
• Supports authoring of the biomarker sections of Investigator Brochures, Clinical Study Protocols and Reports, Statistical and Biomarker Analysis Plans, program documents, and regulatory submissions.
• Evaluates clinical and biomarker data sets from biostatistics and data science, contributes to data analysis, data reviews and interpretation, authors and ensures the quality of study reports and other relevant documents, presents results and insights to internal core teams accompanied by specific, decision making, recommendations.
• Provides translational science related advise to other R&D functions and senior management on all aspects of scientific principles, regulatory guidance, intellectual property (IP), assay development, commercial value, etc.
• Supports regulatory submissions, interactions, inspections, and audits as needed.
• Provides expert support to the evaluation of in-licensing compounds and collaboration opportunities.
• Fosters collaborative relationships and leads discussions with external subject matter experts and academic collaborators.
• Prepares presentations, abstracts, and scientific publications. Presents at international conferences and to internal and external audience.

Education Required:

• Ph.D., M.D., M.D./Ph.D., or Pharm.D. in Pharmacology, Molecular Biology, Biochemistry, Genetics or Related Disciplines

Experience Required:

• Minimum of 5 years of experience in translational and precision medicine research, biomarker sciences, clinical development, and drug discovery.

Experience Preferred:

• Experience in pharmaceutical/biotech or related industries.
• Specialized or technical knowledge in immunology – dermatology, rheumatology, gastroenterology, pulmonology, allergology.
• Experience with regulatory interactions.

Functional Knowledge:

• Deep proficiency in accessing, searching, querying, and downloading data and/or information from various externally available public databases (NCBI, dbGAP, KEGG, OMIM, etc.) for rapid retrieval of key information relevant to PMP and biomarker study design and results interpretation.

Company/Industry Related Knowledge:

• Publication record or industry experience in fields associated with translational science, precision medicine, clinical biomarkers, and early clinical development.
  

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