Associate Director, Clinical Biomarker Lead (CBL)

Teva Pharmaceuticals•West Chester, IA

11d•Hybrid

About The Position

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.Our Team, Your ImpactTeva's global R&D is hiring a Clinical Biomarker Lead (CBL) in the Translational and Precision Medicine group who will be accountable for the development of clinical biomarker strategies across Teva’s drug asset portfolio. The CBL will lead biomarker discovery and development research initiatives which will involve association of molecular, histologic, radiographic, physiologic, and digital biomarkers with drug response and safety. The CBL will be responsible for the planning, design, execution, and interpretation of data from biomarker studies for the assigned drug asset(s), across all phases of drug development, in accordance with Teva’s strategy and priorities, including timely composition of study reports and other relevant documentation. This role will work in close collaboration with various discovery, preclinical and clinical development functions to identify opportunities for enhancing the success of Teva's assets throughout their development life cycle. Travel Requirements: Potential for up to 10-15% - presentation and/or attendance at a scientific association meeting, plus key opinion leaders, scientific advisory boards regulatory meetings, academic collaborations, consortia, and other strategic meetings as required This position will be based out of Parsippany, NJ or West Chester, PA in a hybrid work environment, 2-3 days onsite.How You’ll Spend Your Day 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. CBL is responsible for the development and execution of the Clinical Biomarker Plan and for providing scientific input into Translational and Precision Medicine (TPM) Strategy for the 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, any other relevant asset and/or indication teams. 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. 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. 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. Leads the development and implementation of biospecimen collection plan, develops sample collection schedule, specimen processing methods, handling, shipping, and storage in close collaboration with clinical operations. Reviews clinical study protocols, informed consent forms, training documents, and other relevant study-related materials to ensure alignment with biospecimen collection requirements. Responsible for review of vendor invoices against contract and work completed. 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. In collaboration with 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. Communicates biomarker data to internal stakeholders, external partners, and regulatory authorities as needed.Presents at international conferences and to internal and external audiences (including regulatory bodies, KOLs, payors, etc.).

Requirements

Ph.D. in Immunology, Molecular Biology, Biochemistry, Neuroscience, Genetics or Related Disciplines.
Minimum of 2 years of experience in translation and precision medicine research, biomarker sciences, early clinical development, and/or drug discovery.
Fluent in English.
Excellent interpersonal, verbal and written communication and presentation skills.
Ability to work independently on multiple projects with aggressive timelines.
Ability to progress projects effectively and efficiently. Know when to seek advice from colleagues and senior management.
Interact effectively in a matrix environment with other functions and disciplines using influencing, communication and relationship building skills.

Nice To Haves

Experience in the pharmaceutical industry.
Specialized or technical knowledge in immunology and/or neuroscience.
Experience with regulatory interactions.
Publication record or industry experience in fields associated with translational science, precision medicine, clinical biomarkers, and early clinical development.

Responsibilities

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.
CBL is responsible for the development and execution of the Clinical Biomarker Plan and for providing scientific input into Translational and Precision Medicine (TPM) Strategy for the 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, any other relevant asset and/or indication teams.
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.
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.
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.
Leads the development and implementation of biospecimen collection plan, develops sample collection schedule, specimen processing methods, handling, shipping, and storage in close collaboration with clinical operations.
Reviews clinical study protocols, informed consent forms, training documents, and other relevant study-related materials to ensure alignment with biospecimen collection requirements.
Responsible for review of vendor invoices against contract and work completed.
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.
In collaboration with 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.
Communicates biomarker data to internal stakeholders, external partners, and regulatory authorities as needed.Presents at international conferences and to internal and external audiences (including regulatory bodies, KOLs, payors, etc.).

Benefits

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, and holiday.
Life and Disability Protection: Company paid Life and Disability insurance.
Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.
The total compensation may also include restricted stock units and discretionary awards, depending on the position offered.

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