at AbbVie in North Chicago, Illinois, United States
Job Description
Company Description
AbbVie’s mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
We are seeking a Senior Research Scientist/Principal Research Scientist/Senior Principal Research Scientist Clinical Biomarker Lead to provide non-soluble (e.g., medical imaging, neurophysiology and digital health technologies) and functional biomarker scientific as well as operational expertise. This role will provide support to multiple neuroscience programs implementing scientifically driven clinical development plans. This individual will work with precision medicine, translational imaging and digital science leads along with clinical operations to lead and implement non-soluble biomarker research for Phase 1 to 3 clinical trials. We are seeking an experienced and highly motivated individual who will employ scientific strategies along with operational and logistical strategies to ensure clinical trials are executed with quality and efficiency, on-time, within budget, and meet objectives. The successful candidate will have a proven track record of clinical trial experience and decision-making to achieve these objectives, including subject matter scientific expertise in one or more of the non-soluble and functional methodologies and technologies, strategic thinking, a patient-oriented mindset, team building and cross-functional collaboration.
RESPONSIBILITIES
· Subject matter expertise in one or more of the non-soluble and functional methodologies and technologies (e.g., medical imaging, neurophysiology and digital health technologies) to ensure the biomarker strategy is operationally implemented in trial documents and processes.
· Contribute to the development of clinical biomarker and translational strategic plans and manage implementation of strategies for one or more clinical programs. Responsibility may extend from early translational development activities to mature product life cycle strategies and back translational activities.
· Contributing to scientific collaborations and opinion leader interactions related to the disease area(s); partners with various internal stakeholders from clinical development, discovery, medical affairs, and other internal and external partners
· Pro-actively consult primary scientific literature, keep current on state of art technologies and emerging concepts in the neuroscience biomarker field
· Subject matter expertise in one or more of the non-soluble and functional methodologies and technologies (e.g., medical imaging, neurophysiology and digital health technologies) to ensure the biomarker strategy is operationally implemented in trial documents and processes.
· Manage non-soluble biomarker operations and logistics to support the clinical trial schedule, ensuring data are ready for analysis per timelines.
· Resolve or escalate biomarker study-related issues with precision medicine, translational imaging and digital science leads, as well as clinical study team and clinical operations.
· Responsible for relevant biomarker content in clinical study documents and associated systems (e.g., including clinical trial blueprint/protocol, informed consent forms, lab or operational manuals, eCRFs, CSRs, etc.).
· Responsible for generating study related training materials for the study team, study sites and vendors for each trial. Ensure consistency across programs.
· Performs ongoing biomarker vendor management including development and oversight of scope of work, budgets (invoice review & reconciliation) and performance management.
· Manage biomarker vendor selection and scope, managing contract execution and vendor oversight in compliance with AbbVie’s procedures and applicable regulations. Work closely with key stakeholders in Contracting, Procurement or other AbbVie resources to improve contracting efficiency and reduce costs across PMed.
· Set a positive and motivating work environment that encourages mutual respect, innovation, and accountability at all levels. Balance multiple priorities in a fast-paced, team-based environment and set priorities for self and reports per Department needs.
Significant Work Activities -Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Qualifications
Qualifications
+ Ph.D. Degree with 3+ years project management, clinical trial experience and subject matter scientific background in functional and non-soluble biomarkers (e.g., medical imaging, neurophysiology, and digital health technologies) .
+ Master’s Degree with 6+ years project management, clinical trial experience and subject matter scientific background in non-soluble biomarkers (e.g., medical imaging, neurophysiology, and digital health technologies) .
+ Strong scientific background in neuroscience or related field supported by publication record in these areas.
+ Knowledge of clinical trial methodology, regulatory requirements governing clinical trials, companion diagnostics/in vitro diagnostics, protocol design, and/or experience in development strategy preferred.
+ Proven track record of clinical trial and project management experience; proven ability to work well on teams.
+ Excellent oral and written communications skills in English.
+ Expertise in MS Office applications including Excel, Word and PowerPoint.
+ Organization, attention to detail and effective time management with an ability to adapt to changing priorities.
+ Excellent analytical and interpersonal skills.
+ Experience interacting with various levels within the organization, as well as vendors.
+ Demonstrated ability to run meetings, work collaboratively in a cross-functional environment and drive for success.
+ Experience with global vendor management and assessments of vendors capabilities.
+ Ability to work in a fast-paced, complex environment with minimal supervision.
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+ Position will be hired based on level of experience and location
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ?
+ The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.?
+ We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.?
+ This job is eligible to participate in our short-term incentive programs. ?
+ This job is eligible to participate in our long-term incentive programs. ?
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
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