We are seeking a highly motivated Scientific Director with a proven track record of scientific accomplishments 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. Precision Medicine Leads are responsible 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 responsible for one or more pipeline programs. 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 Precision Medicine lead delivers biomarker results/reports to internal stakeholders and external regulatory agencies. The role ensures that overall 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.
***This position can be located at any one of our R&D sites in Massachusetts, California, or Illinois.***
- 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.
- Leads 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 development of translation- and biomarker-related sections in clinical study-related and regulatory documents (such as clinical protocols, ICFs, INDs, IBs, clinical study reports, etc.).
- Participates in reviews and provides recommendations for business development opportunities.
- Ensures that biomarker sample collections, analyses, data transfers, and reporting are performed in accordance to the study protocol and in compliance with regulatory requirements.
- Mentor junior members of the department and assist their work in translation strategy development and deployment, as well as their development
- Level and compensation will be commensurate with experience.
- Experience and 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 10+ years, or Master’s or Bachelor’s Degree with 15+ years of related work experience in pharmaceutical and/or biotech environment
- Strong scientific background and achievements in Neuroscience and clinical biomarkers 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
- Demonstrated ability to function as Precision Medicine or Translational Lead of development programs and/or late-stage discovery programs
- 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
- Recognized and sought out as an expert in her/his discipline within the company and possibly externally.
Key Leadership Competencies:
- Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
- Learns fast, grasps the "essence" and can change course quickly where indicated.
- Raises the bar and is never satisfied with the status quo.
- Creates a learning environment, open to suggestions and experimentation for improvement.
- Embraces the ideas of others, nurtures innovation and manages innovation to reality.
**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)
Job Type: Experienced