Director Translational Science Lead - Immunology
Parsippany, United States, New Jersey, 07005
Who we are
The opportunity
Teva's R&D Global Early Clinical Development is hiring a Translational Science Lead (TSL) – Immunology in the Translational and Precision Medicine group who will be accountable for the development of translational science plans, testing of scientific hypotheses, and generation of decisional evidence and insights across Teva’s Immunology therapeutic area (TA) drug asset portfolio.
The TSL will contribute to the characterization of the drug target(s), guide indication selection, identify targeted patient populations, support rational drug combinations, and inform mechanisms of action and resistance. The TSL will lead a cross-functional TPM Project Team(s) in a matrix environment and will be responsible for providing translational science guidance to core project teams, clinical development teams, and other functional teams. This role will oversee the analysis of clinical and biomarker data and author relevant sections in the clinical study protocols, statistical analysis plans, study reports, regulatory documents, as well as scientific publications. The TSL will develop and foster collaborative relationships, lead discussions with external subject matter experts and academic collaborators, and present data at international conferences.
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.
The ideal candidate will sit out of Parsippany, NJ office, but for the right candidate we are open to this person being remote and traveling onsite as needed
How you’ll spend your day
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.
Your experience and qualifications
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.
Enjoy a more rewarding choice
We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.
Already Working @TEVA?
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Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
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