Associate Director, Clinical Biomarker Lead (CBL)
Teva Pharmaceuticals
12 hours ago
Remote friendly (West Chester, PA)
United States
Clinical Research and Development
How You’ll Spend Your Day
- 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.
- Develops and executes the Clinical Biomarker Plan; provides scientific input into Translational and Precision Medicine (TPM) Strategy for assigned drug asset(s) in accordance with Teva priorities.
- Leads biomarker development and research initiatives, including association of molecular, histologic, radiographic, physiologic, and digital biomarkers with drug response, safety and/or compliance.
- Participates in project teams, clinical development teams, and other relevant asset and/or indication teams.
- Oversees development/qualification of biomarker technologies and platforms; ensures fit-for-purpose validation of biomarker assays; implements quality control/monitoring of biospecimen testing procedures; ensures compliance with regulatory requirements.
- Qualifies external vendors and ensures transfer and/or selection of cost-effective, appropriately validated assays at CROs and specialty laboratories.
- Executes biomarker testing (planning through timely delivery of data) from biobank samples and samples from Teva’s clinical and/or collaboration studies.
- Leads development/implementation of biospecimen collection plan (schedule, processing methods, handling, shipping, and storage) with clinical operations.
- Reviews clinical study protocols, informed consent forms, training documents, and other study-related materials to ensure alignment with biospecimen collection requirements.
- Reviews vendor invoices against contract and work completed.
- Assesses data providers, selection tools, analytical approaches, and public/private in silico databases to inform biomarker strategies and actionable insights.
- Collaborates with data scientists and biostatisticians on Statistical and Biomarker Analysis Plan (SAP) templates, multi-omics analysis, interpretation of results, timely bioanalytical/study reports, and other relevant documentation.
- Communicates biomarker data to internal/external stakeholders and regulatory authorities as needed; presents at international conferences.
Required
- Ph.D. in Immunology, Molecular Biology, Biochemistry, Neuroscience, Genetics or related disciplines.
- Minimum 2 years of experience in translation and precision medicine research, biomarker sciences, early clinical development, and/or drug discovery.
Preferred
- Experience in the pharmaceutical industry.
- Specialized/technical knowledge in immunology and/or neuroscience.
- Experience with regulatory interactions.
Also Good to Have
- Fluent in English.
- Excellent interpersonal, verbal/written communication, and presentation skills.
- Ability to work independently on multiple projects with aggressive timelines.
- Ability to progress projects effectively; know when to seek advice from colleagues/senior management.
- Ability to interact effectively in a matrix environment.
Benefits
- Comprehensive Health Insurance (Medical, Dental, Vision, Prescription).
- 401(k) with employer match (up to 6%) and annual 3.75% Defined Contribution.
- Paid Time Off (vacation, sick/safe time, caretaker time, holiday).
- Company paid Life and Disability insurance.
- Additional benefits listed in posting (e.g., EAP, Employee Stock Purchase Plan, tuition assistance, FSA/HSA, paid parental leave if eligible, and more).
Application Instructions
- Apply through Teva’s internal career site on Twist.
- 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.
- Develops and executes the Clinical Biomarker Plan; provides scientific input into Translational and Precision Medicine (TPM) Strategy for assigned drug asset(s) in accordance with Teva priorities.
- Leads biomarker development and research initiatives, including association of molecular, histologic, radiographic, physiologic, and digital biomarkers with drug response, safety and/or compliance.
- Participates in project teams, clinical development teams, and other relevant asset and/or indication teams.
- Oversees development/qualification of biomarker technologies and platforms; ensures fit-for-purpose validation of biomarker assays; implements quality control/monitoring of biospecimen testing procedures; ensures compliance with regulatory requirements.
- Qualifies external vendors and ensures transfer and/or selection of cost-effective, appropriately validated assays at CROs and specialty laboratories.
- Executes biomarker testing (planning through timely delivery of data) from biobank samples and samples from Teva’s clinical and/or collaboration studies.
- Leads development/implementation of biospecimen collection plan (schedule, processing methods, handling, shipping, and storage) with clinical operations.
- Reviews clinical study protocols, informed consent forms, training documents, and other study-related materials to ensure alignment with biospecimen collection requirements.
- Reviews vendor invoices against contract and work completed.
- Assesses data providers, selection tools, analytical approaches, and public/private in silico databases to inform biomarker strategies and actionable insights.
- Collaborates with data scientists and biostatisticians on Statistical and Biomarker Analysis Plan (SAP) templates, multi-omics analysis, interpretation of results, timely bioanalytical/study reports, and other relevant documentation.
- Communicates biomarker data to internal/external stakeholders and regulatory authorities as needed; presents at international conferences.
Required
- Ph.D. in Immunology, Molecular Biology, Biochemistry, Neuroscience, Genetics or related disciplines.
- Minimum 2 years of experience in translation and precision medicine research, biomarker sciences, early clinical development, and/or drug discovery.
Preferred
- Experience in the pharmaceutical industry.
- Specialized/technical knowledge in immunology and/or neuroscience.
- Experience with regulatory interactions.
Also Good to Have
- Fluent in English.
- Excellent interpersonal, verbal/written communication, and presentation skills.
- Ability to work independently on multiple projects with aggressive timelines.
- Ability to progress projects effectively; know when to seek advice from colleagues/senior management.
- Ability to interact effectively in a matrix environment.
Benefits
- Comprehensive Health Insurance (Medical, Dental, Vision, Prescription).
- 401(k) with employer match (up to 6%) and annual 3.75% Defined Contribution.
- Paid Time Off (vacation, sick/safe time, caretaker time, holiday).
- Company paid Life and Disability insurance.
- Additional benefits listed in posting (e.g., EAP, Employee Stock Purchase Plan, tuition assistance, FSA/HSA, paid parental leave if eligible, and more).
Application Instructions
- Apply through Teva’s internal career site on Twist.