Medical Director, Hematology Clinical Development

AbbVie•North Chicago, IL

19h

About The Position

With supervision, oversees the direction, planning, execution, and interpretation of clinical trials or research activities for a clinical development program. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data that supports the product’s scientific and business strategy. The role manages study design and implementation, oversees investigator and study-staff education, monitors study integrity and accumulating safety and efficacy data, and works with Clinical Operations on enrollment and timelines. It also contributes scientific content to protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents. The Medical Director may represent assigned protocols on a Clinical Strategy Team and helps develop a rigorous, cross-functionally aligned Clinical Development Plan. The position involves interactions with opinion leaders and collaboration with Medical Affairs, Commercial, and other functions, consistent with corporate policies. The incumbent stays current with professional information and technology, understands and complies with regulatory requirements for clinical studies and global drug development, and ensures research adheres to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards.

Requirements

M.D., D.O., or non-US equivalent of an M.D. degree, with relevant therapeutic specialty in an academic or hospital environment.
Ability to run a clinical research study with appropriate supervision.
Strong desire to collaborate in a cross-functional setting.
Excellent oral and written English communication skills.

Nice To Haves

Completion of a residency program is strongly preferred.
Completion of a subspecialty fellowship is desirable.
Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred.
Knowledge of clinical trial methodology and regulatory and compliance requirements governing clinical trials, and experience designing study protocols, are desirable.
Ability to interact externally and internally to support global scientific and business strategy.

Responsibilities

With appropriate supervision, manage the design and implementation of study protocols for a clinical development program in support of the overall Product Development Plan.
Oversee project-related education of investigators, study-site personnel, and AbbVie study staff.
Oversee clinical studies, monitor overall study integrity, and review, interpret, and communicate accumulating safety and efficacy data.
Work with Clinical Operations to oversee study enrollment and timelines for key deliverables.
Assess and report serious adverse events in accordance with corporate policy and regulations for assigned protocols.
Contribute to the design, analysis, interpretation, and reporting of scientific content for 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 assigned protocols.
Collaborate with matrix team members to develop a rigorous, cross-functionally aligned, vetted Clinical Development Plan.
Participate in opinion leader interactions related to the disease area and partner with Medical Affairs, Commercial, and other functions as required and consistent with corporate policies.
Stay current with professional information and technology through conferences, medical literature, and other training.
Understand regulatory requirements related to clinical studies and global drug development, and comply with those requirements.
May contribute to regulatory responses and discussions.
Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards in research.
Participate in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting product scientific and business strategy.