Teva Director Clinical Biomarker Lead 

Israel, Center District, Netanya 

726693382

1. Clinical Biomarker Lead (CBL) supports asset programs by enhancing probability of success and de-risking development of candidates in all phases of clinical development from first in human (FIH) through post-approval.
2. CBL is responsible for the development and execution of the Clinical Biomarker Plan and for providing scientific input into the Translational Science Plan as well as the overall Translational and Precision Medicine (TPM) Strategy for the assigned drug asset(s) in accordance with Teva priorities.
3. Leads biomarker development and research initiatives, including association of molecular, histologic, radiographic, physiologic, and digital biomarkers with drug response, safety and/or compliance.
4. Participates in project teams, clinical development teams, any other relevant asset and/or indication teams.
5. Oversees development and qualification of technologies and platforms for biomarker research, fit-for-purpose validation of biomarker assays, implementation of quality control and monitoring of biospecimen testing procedures, and assures compliance of biomarker analysis with regulatory requirements.
6. Works with outside departments on qualification of external vendors and ensures transfer and/or selection of cost-effective and appropriately validated assays at CROs and specialty laboratories.
7. Responsible for the execution of biomarker testing, from planning to timely delivery of data, from biobank samples and samples from Teva’s clinical and/or collaboration studies.
8. Leads the development and implementation of biospecimen collection plan, develops sample collection schedule, specimen processing methods, handling, shipping, and storage, according to the priorities of TSL and in close collaboration with clinical operations.
9. Reviews clinical study protocols, informed consent forms, training documents, and other relevant study-related materials to ensure alignment with biospecimen collection requirements.
10. Responsible for review of vendor invoices against contract and work completed.
11. Participates in the assessment of data providers, selection tools, analytical approaches, and relevant public or private in silico databases to inform biomarker strategies and generation of actionable scientific insights for internal decision making.
12. In collaboration with TSL, data scientists and biostatisticians, contributes to the development of the Statistical and Biomarker Analysis Plan (SAP) templates, analysis of multi-omics data, interpretation of results, timely composition of bioanalytical and study reports as well as drafting of other relevant documentation.
13. Communicates biomarker data to internal stakeholders, external partners, and regulatory authorities as needed.
14. Presents at international conferences and to internal and external audiences (including regulatory bodies, KOLs, payors, etc.).
    

1. Ph.D. in Pharmacology, Molecular Biology, Biochemistry, Genetics or Related Disciplines.
2. 5-7+ years of experience in translation and precision medicine research, biomarker sciences, clinical development, and drug discovery.
3. Experience in pharmaceutical industry-Preferred
4. Specialized or technical knowledge in neuroscience, immunology and/or oncology.
5. Experience with regulatory interactions.
6. Specialized or Technical Knowledge Licenses, Certifications needed:
7. Company/Industry Related Knowledge:Publication record or industry experience in fields associated with translational science, precision medicine, clinical biomarkers, and early clinical development.
8. Fluent in English.
9. Excellent communication and presentation skills.
10. Strong sense of urgency and understanding of meeting firm deadlines.
11. Ability to work on multiple projects and aggressive timelines.
12. Ability to thrive and enjoy working independently in a fast-paced, multitasking environment.
13. Excellent interpersonal, verbal and written communication skills. Ability to manage multiple conflicting priorities and varied concurrent tasks.
14. Ability to progress projects effectively and efficiently. Know when to seek advice from colleagues and senior management.
15. Interact effectively across boundaries with other functions and disciplines using influencing, communication and relationship building skills.
    

Vice President Translational & Precision Medicine

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