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Early Childhood Development Manager
3 weeks ago
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Early Childhood Development Manager
2 weeks ago
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VP, Early Career Development
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Talent Development Consultant Early Careers
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Director, Early Phase Analytical Development
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Medical Director, Oncology Early Development
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Early Childhood Development Coordinator
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RefugeeOne Chicago, United States**Organization** · RefugeeOne, located in Chicago's West Ridge neighborhood, has a national reputation for its success in helping refugees fleeing war, terror, and persecution to build new lives of safety, dignity, and self-reliance. RefugeeOne has a remarkably diverse staff of 1 ...
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Talent Development Consultant Early Careers
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Talent Development Consultant Early Careers
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Old National Bank Chicago, United StatesOverview · Old National Bank has been serving clients and communities since 1834. With $48 billion in total assets, we are a regional powerhouse deeply rooted in the communities we serve. As a trusted partner, we thrive on helping our clients achieve their goals and dreams, and w ...
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Director, Early Phase Analytical Development
1 month ago
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Medical Director, Oncology Early Development
3 weeks ago
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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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Astellas Pharmaceuticals Northbrook, United StatesDo you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Aste ...
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Early Career Program Lead
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Preschool Spanish Teacher
2 weeks ago
Sonnets Academy Chicago, United States Full timeSonnets Academy, a leading private preschool and infant care program, in Chicago, seeking an Early Childhood Spanish Teacher for its three locations. This position would be full time. Monday through Friday is required, however a planning day would be provided. · The Early Childho ...
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Teacher for Twos Classroom
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Toddler Teacher
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Infant Teacher
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Substitute Teacher PT-Child Development
2 weeks ago
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Assistant Teacher
1 week ago
City Colleges of Chicago Chicago, United StatesASSISTANT TEACHER – PT · KENNEDY-KING COLLEGE · CHILD DEVELOPMENT CENTER · City Colleges of Chicago (CCC), the largest community college system in Illinois, is made up of seven colleges and five satellite sites, providing more than 70,000 students each year access to a qualit ...
Senior Medical Director, Oncology Early Development - North Chicago, United States - AbbVie
Description
Job Description
Job DescriptionCompany DescriptionAbbVie'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 Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job DescriptionThe 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 business strategy.
Responsibilities:
•Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff.
•Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
•Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
•May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.
•May serve on or chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs).
•Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
•Acts as clinical lead and actively solicits 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 Clinical Development Plans and protocols as appropriate.
•Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings.
•Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a 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.
•Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
•At least 5 years (7 years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
•Ability to run a complex clinical research program independently.
•Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.
•Ability to interact externally and internally to support a global scientific and business strategy.
•Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.
•Must possess excellent oral and written English communication skills.
•Ability to exercise judgment and address complex problems and create solutions for one or more projects.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's 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.