AbbVie Medical Director/Scientific Director oversees clinical trials and research activities in immunology clinical development. Manages study protocols, monitors study integrity, and contributes to clinical strategy and regulatory compliance.
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 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 responsibility for oversight of clinical studies, 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 oversight of 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.
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 for which the incumbent has responsibility. Contributes to the development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan in collaboration with matrix team members.
Participates in 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.
Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area.
Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May be asked to contribute to regulatory responses and discussions.
Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
Medical Director Qualifications:
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.
Ability to run a clinical research study with appropriate supervision.
Strong desire to collaborate in a cross-functional setting.
Qualification
Required
Ability to oversee clinical trials or research activities with supervision
Knowledge of compliance and regulatory requirements
Understanding of Good Clinical Practices and pharmacovigilance standards
