BioSpace
Associate Medical Director/Medical Director, Clinical Development(Neuroscience/P
BioSpace, North Chicago, Illinois, us, 60086
Overview
Associate Medical Director/Medical Director, Clinical Development (Neuroscience/Psychiatry). Responsibilities
With appropriate supervision, manages the design and implementation of study protocols for a clinical development program in support of the overall Product Development Plan, based on medical and scientific principles, regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff. Oversees the design, conduct, monitoring of studies, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Oversees enrollment and overall timelines for key deliverables with Clinical Operations. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for assigned protocols. Contributes to design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents. May serve on a Clinical Strategy Team as the clinical representative for the protocols with responsibility. Contributes to development of a rigorous, cross-functionally-aligned Clinical Development Plan with matrix team members. Participates in opinion leader interactions related to the disease areas; partners with Medical Affairs, Commercial and other functions as required, consistent with corporate policies. Stays abreast of professional information and technology through conferences, medical literature, and other available training to augment expertise in the therapeutic area. Understanding regulatory requirements related to clinical studies and global drug development; accountable for compliance. May contribute to regulatory responses and discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, SOPs and other quality standards in conducting research. Qualifications
Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent with relevant therapeutic specialty; completion of residency strongly preferred; subspecialty fellowship desirable. Ability to run a clinical research study with appropriate supervision. Strong desire to collaborate in a cross-functional setting. Clinical trial experience in pharmaceutical industry, academia, or equivalent preferred. Knowledge of clinical trial methodology, regulatory and compliance requirements; experience in study protocol design desirable. Ability to interact externally and internally to support global scientific and business strategy. Excellent oral and written English communication skills. Additional Information
The compensation range described is a range of possible base pay based on job grade and may vary by geographic location; the Company may pay more or less than the posted range. The range may be modified in the future. We offer a comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in short-term and long-term incentive programs. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only: for equal employment opportunity information, see the company website. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.
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Associate Medical Director/Medical Director, Clinical Development (Neuroscience/Psychiatry). Responsibilities
With appropriate supervision, manages the design and implementation of study protocols for a clinical development program in support of the overall Product Development Plan, based on medical and scientific principles, regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff. Oversees the design, conduct, monitoring of studies, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Oversees enrollment and overall timelines for key deliverables with Clinical Operations. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for assigned protocols. Contributes to design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents. May serve on a Clinical Strategy Team as the clinical representative for the protocols with responsibility. Contributes to development of a rigorous, cross-functionally-aligned Clinical Development Plan with matrix team members. Participates in opinion leader interactions related to the disease areas; partners with Medical Affairs, Commercial and other functions as required, consistent with corporate policies. Stays abreast of professional information and technology through conferences, medical literature, and other available training to augment expertise in the therapeutic area. Understanding regulatory requirements related to clinical studies and global drug development; accountable for compliance. May contribute to regulatory responses and discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, SOPs and other quality standards in conducting research. Qualifications
Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent with relevant therapeutic specialty; completion of residency strongly preferred; subspecialty fellowship desirable. Ability to run a clinical research study with appropriate supervision. Strong desire to collaborate in a cross-functional setting. Clinical trial experience in pharmaceutical industry, academia, or equivalent preferred. Knowledge of clinical trial methodology, regulatory and compliance requirements; experience in study protocol design desirable. Ability to interact externally and internally to support global scientific and business strategy. Excellent oral and written English communication skills. Additional Information
The compensation range described is a range of possible base pay based on job grade and may vary by geographic location; the Company may pay more or less than the posted range. The range may be modified in the future. We offer a comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in short-term and long-term incentive programs. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only: for equal employment opportunity information, see the company website. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.
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