- Drive clinical protocol development from high-level study concept to detailed protocol, supporting decisions regarding critical components of design (e.g. eligibility criteria, sample size, assessments) with appropriate literature review and discussions with key opinion leaders
- Monitor, analyze, and present safety, efficacy, pharmacodynamic, and pharmacokinetic data from clinical studies
- Aggregate and synthesize data from multiple sources - such as the clinical database, TLFs, and literature review - to provide integrated assessments of clinical study findings
- Develop scientific expertise in focused areas (e.g., selected functional assessments) to drive clinical development activities
- Formulate key messages and author clinical content for key documents including clinical study reports, investigator brochures, and publications (abstracts, posters, manuscripts)
- Engage with investigators, site staff, CROs, site monitors and patient/disease advocacy organizations to support ongoing clinical studies
- Author and review key documents to support clinical components of regulatory submissions (e.g., briefing documents, responses to queries, applications for expedited program designations)
- Develop presentations for meetings with internal/external stakeholders including advisory boards, Data Safety Monitoring Boards, Executive Steering Committees, and Board of Directors
- Collaborate within clinical development and cross-functionally on the creation and maintenance of the clinical development plan (CDP) ensuring alignment with the Target Product Profile (TPP) and accounting for feasibility and regional requirement
- Advanced scientific degree (Ph.
- Knowledge in the principles of good clinical practices (GCPs), clinical research methodology, statistics, data analysis and interpretation
- Familiar with scientific literature searches and weighing of quality peer-reviewed data
- Ability to clearly communicate to internal and external stakeholders orally and in writing (MS Word); effective knowledge of MS PowerPoint
- Strong interpersonal skills to interact with investigators, vendors, and individuals at all levels of the organization
- Prior neurology or pain experience highly preferre
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Associate Director, IT Clinical Development
3 weeks ago
AbbVie North Chicago, United States**Company Description** · Take the next step in your career with an organization that strategically invests in the long-term health of the company, its technology, and its people. The AbbVie Business Technology Solutions (BTS) team shapes the digital transformation necessary for ...
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Business Analyst Clinical Development
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WellBe Senior Medical Chicago, United StatesJob Summary: · **WELLBE INTRODUCTION** · The WellBe care model is a Physician Led Advanced Practice clinician driven geriatric care (care of older adults) team focused on the care of the frail, poly-chronic, elderly Medicare Advantage patients. This population is typically unders ...
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Director of New Clinic Development
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Symetria Recovery Chicago, United StatesWho we are: · Symetria Recovery is the #1 outpatient rehab in Illinois and Texas. It started with three simple, yet game-changing core beliefs: Addiction is a disease; co-occurring mental health conditions should be addressed, and patients deserve respect, not judgement. Symetri ...
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AbbVie North Chicago, United StatesJob Description · Job DescriptionCompany 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 acr ...
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AbbVie North Chicago, United StatesJob Description · Job DescriptionCompany 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 acr ...
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AbbVie North Chicago, United StatesJob Description · Job DescriptionCompany 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 acr ...
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AbbVie North Chicago, United StatesJob Description · Job DescriptionCompany 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 acr ...
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AbbVie North Chicago, United StatesJob Description · Job DescriptionCompany 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 acr ...
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AbbVie North Chicago, United StatesJob Description · Job DescriptionCompany 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 acr ...
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AbbVie North Chicago, United StatesJob Description · Job DescriptionCompany 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 acr ...
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AbbVie North Chicago, United StatesJob Description · Job DescriptionCompany 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 acr ...
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Director of New Clinic Development
1 week ago
Symetria Recovery Chicago, United StatesWho we are: · Symetria Recovery is the #1 outpatient rehab in Illinois and Texas. It started with three simple, yet game-changing core beliefs: Addiction is a disease; co-occurring mental health conditions should be addressed, and patients deserve respect, not judgement. Symetri ...
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AbbVie North Chicago, United StatesJob Description · Job DescriptionCompany 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 acr ...
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Executive Medical Director Clinical Development
3 weeks ago
Rbw Consulting Chicago, United StatesRBW is partnered with a large pharmaceutical company that is looking to looking to expand their late phase clinical development team. · Job Summary · Our client is looking to hire an experienced Executive Medical Director Clinical Development who is interested in a global develo ...
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AbbVie North Chicago, United StatesJob Description · Job DescriptionCompany 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 acr ...
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Clinical Software Market Development Manager
1 week ago
Danaher Corporation Chicago, United StatesDanaher Corporation · Clinical Software Market Development Manager · in · Chicago , · Illinois · In our line of work, life isn't a given - it's the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic d ...
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Medical Director Oncology Clinical Development
3 weeks ago
AbbVie North Chicago, United StatesJob Description · Job DescriptionCompany 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 acr ...
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AbbVie North Chicago, United States Full time· 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 ar ...
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AbbVie North Chicago, United States Full time· 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 ar ...
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AbbVie North Chicago, United States Full time· 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 ar ...
Scientific Director, Clinical Development - Chicago, United States - Exicure, Inc.
Description
Exicure, Inc. is seeking a motivated Scientific Director to join its expanding clinical development team.The Scientific Director will report to the Head of Clinical Development/Medical Lead and will provide scientific, clinical, and feasibility input to early and late stage clinical development programs with an emphasis on protocol development, study monitoring, and data interpretation and presentation.
This role will work on rigorous design and execution of clinical studies, as well as lead systematic literature research and technical data analyses.
The Scientific Director will serve as a point of contact for investigators and CROs in day-to-day clinical study needs. The candidate must be highly motivated, adept at problem solving, articulate, and collaborative.Responsibilities:
Education / Experience:
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