Principal Research Scientist

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Job description

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn .

POSITION DESCRIPTION:

We are seeking a highly motivated Translational Scientist to join our growing Precision Medicine organization. The Neuroscience department within Precision Medicine at AbbVie is responsible to develop and deliver translational strategy and increase confidence in success of a growing innovative AbbVie Neuroscience Portfolio with broad Neuroscience indications. To equip present and future Neuroscience pipelines, the team takes a modality-agonistic translational approach and collaborates with internal and external experts of translational technologies including fluid, imaging and digital biomarkers and CNS liquid biopsy. Principal Scientist / Clinical Biomarker Lead are being a critical contributor in development and deployment of translational strategy for Neuroscience Pipeline Programs in late-stage discovery and across clinical development stages, FTiH, proof-of-mechanism, proof-of-concept, registration studies as well as life cycle management. This Role will be involved in one or more pipeline programs with support and guidance from senior members of the department. This role oversees target binding, pharmacodynamic, mechanism of action, patient selection and segmentation, impact in disease progression, and other clinically relevant biomarker studies through internal, external, and internal/external hybrid operational models. Through close collaborations with Discovery, Clinical Development, Clinical Pharmacology and Modeling, Data Science, Clinical Operation, and Regulatory Departments, the Principal Scientist / Clinical Biomarker Lead delivers biomarker results/reports to internal stakeholders. The role ensures that budgets, schedules, and performance standards are attained and is accountable for the execution of translational strategy in Neuroscience clinical studies, in compliance with AbbVie's processes and regulatory requirements.

RESPONSIBILITIES:

• Works in the Neuroscience Department within the Precision Medicine organization to develop, establish, and lead efforts aimed at 1) target binding and engagement, 2) pharmacodynamics, 3) patient selection and segmentation markers, 4) disease relevant biomarkers with association to clinical endpoints, in early and late stage Neuroscience studies.
• Be an integral part of cross-functional Translational Neuroscience Team to drive translational strategy development that includes selection of biomarkers and assays based on a deep biological understanding of mechanisms of action, disease/disorder progression, and Neuroscience biology.
• Undertakes cross-functional engagement with Clinical Science and Clinical Operations for implementation of biomarker analyses in the clinic.
• Manages relationships with external analytical labs, provide input into trial-specific agreements and perform technical assessment of labs involved in biomarker sample analysis. Coordinates between CRO assay development group and clinical team, when necessary.
• Leads drafting of translation- and biomarker-related sections in clinical study-related and regulatory documents (such as clinical protocols, ICFs, INDs, IBs, clinical study reports, etc.).
• Ensures that biomarker sample collections, analyses, data transfers, and reporting are performed in accordance to the study protocol and in compliance with regulatory requirements.
• Level and compensation will be commensurate with experience.

Qualifications

QUALIFICATIONS

• Experience and ideally proven record in leading and/or supporting translational strategy of Neuroscience programs in clinical development in pharmaceutical and/or biotech environment
• PhD, PharmD, and/or MD with 3+ + years, or Master's or Bachelor's Degree with 5+ years of related work experience in pharmaceutical and/or biotech environment

Preferred Qualifications:

• Strong scientific background and achievements in Neuroscience and clinical biomarkers ideally demonstrated by scientific publications, presentations and/or patents
• Expertise and experience in indications covered by current AbbVie Neuroscience portfolio
• Interdisciplinary knowledge of broad biomarker approaches and enabling technologies
• Demonstrate creative 'out of the box' thinking to solve difficult technical problems and champion new technologies to achieve project goals.
• Ability to work on multiple programs concurrently and meet timelines
• Ability to work in matrix-based program teams
• Experiences in development of clinical study documents, such as investigator broachers, clinical protocols, procedure manuals and/or regulatory documents

Key Leadership Competencies:

• Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
• Raises the bar and is never satisfied with the status quo.

**Equal Opportunity Employer Minorities/Women/Veterans/Disabled**

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 10 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.