Medical Director, Hematology Clinical Development

AbbVie•Waltham, MA

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 overall product scientific and business strategy. The role manages study protocol design and implementation with appropriate supervision, oversees study integrity and safety and efficacy data, and works with Clinical Operations on enrollment and timelines. It contributes scientific content to protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents. The Medical Director collaborates with matrix team members on the Clinical Development Plan, participates in disease-area opinion leader interactions, and maintains therapeutic-area expertise through professional information and training. The role is accountable for understanding and complying with regulatory requirements, Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards.

Requirements

Medical Doctor (M.D.), Doctor of Osteopathy (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.
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, is desirable.

Responsibilities

Manage the design and implementation of study protocols for a clinical development program, with appropriate supervision, in support of the Product Development Plan.
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 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.
Collaborate with matrix team members to develop a rigorous, cross-functionally aligned, vetted Clinical Development Plan.
Participate in opinion leader interactions related to disease areas, partnering with Medical Affairs, Commercial, and other functions as required and consistent with corporate policies.
Maintain professional and technological expertise through conferences, medical literature, and other available 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 conducting research.