Medical Director, Hematology Clinical Development

AbbVie•Waltham, MA

2d•$182,000 - $346,000

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 manages and oversees clinical study design and implementation, study integrity, safety and efficacy data review, enrollment, timelines, and serious adverse event assessment and reporting. It contributes to scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents. The position may represent the clinical function on a Clinical Strategy Team and helps develop a cross-functionally aligned Clinical Development Plan. The Medical Director participates in opinion-leader interactions, maintains therapeutic-area expertise, understands and complies with regulatory requirements, and ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards.

Requirements

M.D., D.O., or non-U.S. equivalent 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.
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 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.
Together with Clinical Operations, 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.
Contribute to development of a rigorous, cross-functionally aligned and vetted Clinical Development Plan with matrix team members.
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.
Maintain professional and therapeutic-area expertise through conferences, medical literature, and other training.
Understand regulatory requirements related to clinical studies and global drug development, comply with them, and potentially contribute to regulatory responses and discussions.
Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards in research.