Associate Medical Director/Medical Director, Clinical Development(Neuroscience/Psychiatry)

AbbVie • North Chicago, IL

101d

About The Position

With supervision, oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy.

Requirements

• 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.
• Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred.
• Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols is desirable.
• Ability to interact externally and internally to support global scientific and business strategy.
• Must possess excellent oral and written English communication skills.

Responsibilities

• Manages the design and implementation of study protocols for a clinical development program in support of the overall Product Development Plan.
• 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.
• 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.
• Stays abreast of professional information and technology through conferences, medical literature, and other available training.
• Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k) to eligible employees
• Short-term incentive programs
• Long-term incentive programs

What This Job Offers

• Industry: Chemical Manufacturing
• Education Level: Master's degree