Medical Director, Hematology Clinical Development

AbbVie•Waltham, MA

2d•$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 the product’s scientific and business strategy. The role includes designing and implementing study protocols, overseeing study integrity and safety and efficacy data, contributing to clinical development plans and regulatory documents, and ensuring compliance with applicable clinical research standards and regulations.

Requirements

M.D., D.O., or non-U.S. equivalent M.D. degree with a 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, applying medical and scientific principles and knowledge of compliance and regulatory requirements, customers, markets, business operations, and emerging issues.
Oversee project-related education for 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 for assigned protocols in accordance with corporate policy and regulations.
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 as the clinical representative on a Clinical Strategy Team for assigned protocols and contribute to a rigorous, cross-functionally aligned Clinical Development Plan with matrix team members.
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 on 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; may contribute to regulatory responses and discussions.
Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards in conducting research.