Executive Medical Director Oncology Clinical Development
4 weeks ago
Accountable for reports who lead and have ownership of the design and implementation of multiple clinical development programs in support of the overall product development plans, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues. Ensures that staff provides project-related education of investigators, study site personnel, and AbbVie study staff.
Trains and lends expertise to staff who serve on Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs), and who lead Clinical Strategy Teams (CSTs) and clinical study teams, to ensure high-quality, cross-functionally-aligned program (i.e., Clinical Development Plan) and study deliverables with full consideration of contingencies and alternative approaches. Ensures that staff have capabilities to monitor overall study integrity, study enrollment and timelines.
Provides or ensures clarity regarding the appropriate level for review and approval of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
Manages two levels of Medical and Scientific Directors (typically 2 to 4 direct; 6 or more overall) and/or Clinical Scientists. This responsibility involves direct oversight of clinical development activities and/or management of personnel who may be working on other projects. Responsible for hiring, onboarding, mentoring, training, and supporting career development of these individuals.
In rare circumstances, may lead a CST for an unusually complex, high-priority program. In this capacity, responsibilities may include supervision of matrix team members and serving as the Clinical Research representative to lend clinical development and medical expertise to ADTs and ALBs, and/or other cross-functional teams and internal stakeholders.
Serves as the in-house clinical and drug development expert broadly across several molecules and disease areas in the therapeutic area, directing appropriate scientific activities with internal stakeholders as they relate to ongoing projects. May lead clinical development contributions to due diligence or other business development activity. Contributes in partnership with Discovery colleagues to design and implementation of translational strategies at a disease area and platform level.
Acts as a senior-level liaison for opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into disease area strategies and Clinical Development Plans as appropriate.
Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. Actively seeks opportunities to represent AbbVie at key external meetings and enhance AbbVie’s reputation as an industry leader.
Responsible for having deep understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a senior clinical representative for key regulatory discussions.
Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
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Chicago, United States Rbw Consulting Full timeRBW 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 development leader / clinical lead role. This person will oversee at least two studies in...
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Clinical Trial Associate
2 weeks ago
Chicago, Illinois, United States Alliance for Clinical Trial in Oncology Foundation Full timeThe Alliance for Clinical Trials in Oncology Foundation (Foundation) is a foundation created to enhance and expand the ability of the Alliance for Clinical Trials in Oncology (Alliance) to conduct cancer clinical research and address important treatment questions through large-scale clinical trials. Through efforts of the Foundation in support of the...
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North Chicago, United States AbbVie, Inc Full timeCompany 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...
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North Chicago, Illinois, United States AbbVie Full timeJob Description The Senior Medical Director leads the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and...
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Medical Director, Oncology Early Development
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Clinical Trial Research Nurse
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Chicago, Illinois, United States Alliance for Clinical Trial in Oncology Foundation Full timeThe Alliance for Clinical Trials in Oncology Foundation (Foundation) is a foundation created to enhance and expand the ability of the Alliance for Clinical Trials in Oncology (Alliance) to conduct cancer clinical research and address important treatment questions through large-scale clinical trials. Through efforts of the Foundation in support of the...
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Associate Medical Monitor
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Chicago, Illinois, United States Alliance for Clinical Trial in Oncology Foundation Full timeThe Alliance for Clinical Trials in Oncology Foundation (Foundation) is a foundation created to enhance and expand the ability of the Alliance for Clinical Trials in Oncology (Alliance) to conduct cancer clinical research and address important treatment questions through large-scale clinical trials. Through efforts of the Foundation in support of the...
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Medical Director of Oncology Assay Development
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Chicago, Illinois, United States AbbVie Full timeCompany DescriptionAbbVie is on a mission to discover and deliver cutting-edge medicines and solutions that tackle critical health issues today and anticipate the medical challenges of tomorrow. The company aims to make a significant impact on people's lives in key therapeutic areas such as immunology, oncology, neuroscience, and eye care, including...
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Clinical Trial Associate
1 week ago
Chicago, United States Alliance for Clinical Trial in Oncology Foundation Full timeJob DescriptionJob DescriptionThe Alliance for Clinical Trials in Oncology Foundation (Foundation) is a foundation created to enhance and expand the ability of the Alliance for Clinical Trials in Oncology (Alliance) to conduct cancer clinical research and address important treatment questions through large-scale clinical trials. Through efforts of the...
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Associate Director, Biomarker Program Management
4 weeks ago
North Chicago, Illinois, United States AbbVie Full timeJob Description The Precision Medicine (PMed) Oncology organization at AbbVie uses advanced methods to discover biomarkers and implement translational strategies to advance AbbVie’s innovative Oncology pipeline. The Associate Director, Biomarker Program Management, leads a team within the Oncology therapeutic area that connects science and operations to...
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Mettawa, Illinois, United States AbbVie Full timeJob Description The Director, Business Development, Global Commercial Development will report to the Director, Pipeline Commercialization & Strategy, Oncology. This person will play an integral driving role in the sourcing and evaluation of new investment opportunities through the leadership and management of commercial assessments related to the TA...
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North Chicago, United States AbbVie, Inc Full timeCompany 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...
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North Chicago, Illinois, United States AbbVie Full timeJob 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 our treatments to positively impact patients’ lives. In the role of Associate Director,...
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Compliance Specialist
3 weeks ago
Chicago, Illinois, United States Alliance for Clinical Trial in Oncology Foundation Full timeThe Alliance for Clinical Trials in Oncology Foundation (Foundation) is a foundation created to enhance and expand the ability of the Alliance for Clinical Trials in Oncology (Alliance) to conduct cancer clinical research and address important treatment questions through large-scale clinical trials. Through efforts of the Foundation in support of the...
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North Chicago, Illinois, United States AbbVie Full timeJob Description AbbVie’s Development Biological Sciences department is seeking a Scientific Director for its Portfolio Leadership Group. The primary function of this role will be to serve as a nonclinical safety representative for assigned molecules across AbbVie’s diverse portfolio. As a safety representative, the Scientific Director will be...
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Nurse Practitioner
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Director of Clinical Services
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North Chicago, United States AbbVie, Inc Full timeCompany 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...
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North Chicago, Illinois, United States AbbVie Full timeJob Description The Associate Director, RA Global Regulatory Strategy, US & Canada (Oncology) is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. This individual demonstrates the ability to combine knowledge of scientific,...
