- Utilize scientific and operational expertise in neurology and neuropsychiatry drug development to ensure brain function and non-soluble biomarkers are executed in neuropsychiatry and neurology clinical trials with high efficiency and within budget and timelines.
- Work cross-functionally and apply strategic thinking to facilitate the development of clinical and translational biomarker strategies and manage implementation of strategies for multiple clinical development programs in neuropsychiatry and neurology indications. Responsibility may extend from early translational development activities to mature product life cycle strategies and back-translational activities.
- Proactively consult primary scientific literature and stay current on state-of-the-art technologies and emerging precision medicine and biomarker concepts in the neuropsychiatry and neurology fields and make recommendations to precision medicine leads.
- Manage brain function and non-soluble biomarker operations and logistics to support the clinical study and data analysis timelines.
- Resolve or escalate biomarker-related clinical study issues with precision medicine, translational imaging, digital science, and clinical operations leads and clinical study team.
- Draft and be responsible for biomarker content in clinical study documents and associated systems, including clinical trial protocols, informed consent forms, operations manuals, case report forms, and clinical study report appendices.
- Generate and review biomarker-related training materials for clinical study teams, study sites, and/or biomarker vendors. Ensure consistency across neurology and neuropsychiatry clinical development programs.
- Oversee biomarker vendor selection, contract execution, and vendor oversight in compliance with AbbVies procedures and applicable regulations, and in collaboration with key stakeholders in Contracting, Procurement, or other AbbVie resources.
- Perform ongoing biomarker vendor management including development and oversight of scope, budget development, invoice review & reconciliation, and performance management.
- 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 per Department needs. Significant Work Activities -Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Qualifications
Sr. Scientist I -Masters Degree in neuroscience or related field or equivalent education and typically 8 years of experience or PhDneuroscience or related field and no experience necessary. - Experience operationalizing biomarkers in clinical studies preferred.
- Scientific and operational knowledge of functional and non-soluble biomarkers used in neuropsychiatry/neurology drug development (e.g.,neuroimaging, neurophysiology/EEG, physiology, etc. using conventional and/or digital technologies).
- Knowledge of clinical trial methodology, regulatory requirements governing clinical trials, and clinical trial protocol design.
- Proven track record of project management experience.
- Experience with global vendor management and assessment of vendor capabilities.
- Proven ability to work collaboratively within cross-functional teams.
- Excellent oral and written communication skills in English.
- Expertise in MS Office applications including Excel, Word and PowerPoint.
- Highly effective time management with an ability to quickly adapt to changing priorities.
- Excellent organizational and project management skills and attention to detail.
- Ability to work in a fast-paced environment with minimal supervision.
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 ingood faith it will pay for this role at the time of this postingbased on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay more orless 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/visioninsurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs. Note: No amount of payis considered to bewages 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 benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidandmay be modified at the Companys sole and absolute discretion, consistent with applicable law. AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.
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Sr. Scientist I, Precision Medicine, Neuroscience Biomarkers - Cambridge, United States - AbbVie
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 Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description
We are seeking an experienced and highly motivated Senior Scientist I to provide scientific, operational, and logistical support for implementing biomarker strategies in multiple neurology and neuropsychiatry,psychiatry clinical development programs. Biomarkers will span brain function and non-soluble modalities including neuroimaging, neurophysiology/EEG, physiology, and others using conventional, computer-based, and digital technologies. This individual will work cross-functionally with precision medicine, clinical imaging, digital science, data science, and clinical operations leads to implement biomarker research in Phase 1 to 4 clinical trials The successful candidate will have a proven track record of pharmaceutical industry clinical study experience and decision-making to achieve objectives, as well as scientific knowledge of brain function and/or non-soluble biomarker technologies and methodologies.
RESPONSIBILITIES
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