Medical Director, Hematology Clinical Development

AbbVie•North Chicago, IL

6h•$192,500 - $327,000

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 supporting product scientific and business strategy. The role manages the design and implementation of study protocols, oversees clinical study integrity and timelines, and reviews and communicates accumulating safety and efficacy data. It contributes scientific content to protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents. The Medical Director may represent protocols on a Clinical Strategy Team and collaborates with matrix team members to develop a rigorous, aligned Clinical Development Plan. The position also participates in disease-area opinion leader interactions, maintains expertise through professional literature, conferences, and training, and ensures compliance with applicable regulatory requirements, Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards.

Requirements

M.D., D.O., or non-U.S. equivalent 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.
Ability to interact internally and externally to support global scientific and business strategy.
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.

Responsibilities

With appropriate supervision, manage the design and implementation of study protocols for a clinical development program in support of the 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.
Partner with Clinical Operations to oversee study enrollment and timelines for key deliverables.
Assess and report serious adverse events according to 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 and collaborate with matrix team members on the Clinical Development Plan.
Participate in opinion leader interactions related to the disease area, partnering 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 and comply with regulatory requirements related to clinical studies and global drug development; contribute to regulatory responses and discussions as requested.
Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards in conducting research.