Senior Medical Director

AbbVie•North Chicago, IL

15d

About The Position

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.Oversees the direction, planning, execution, and interpretation of clinical pharmacology trials or research activities of one or more clinical development programs as the principal investigator. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical pharmacology data supporting overall product scientific and business strategy.•Manages the design and implementation of multiple clinical pharmacology trials in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. Oversees project-related education of sub investigators, study site personnel, and AbbVie Clinical Pharmacology Research Unit (ACPRU) study staff.•Has overall responsibility for oversight of clinical pharmacology studies as the principal investigator, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with ACPRU operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.•Responsible for design, execution, analysis, interpretation, and reporting of scientific content of protocols and Clinical Study Reports.•May oversee the work of Associate Medical and/or Scientific Directors, and of Clinical Scientists working on the same or related studies.•Provides in-house clinical expertise as a principal investigator or sub investigator for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.•Acts as a clinical interface and actively solicits opinion leader interactions related to healthy volunteers; partners with other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.•Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in clinical pharmacology.•Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements.•Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

Requirements

Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program and ability to obtain an Illinois license to practice medicine. Completion of a subspecialty fellowship is desirable.
At least 2 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
Ability to run a clinical research program of moderate complexity with minimal supervision.
Ability to perform and bring out the best in others on a cross-functional global team.
Ability to interact externally and internally to support a global scientific and business strategy.
Knowledge of clinical pharmacology trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols.
Must possess excellent oral and written English communication skills.

Responsibilities

Oversees the direction, planning, execution, and interpretation of clinical pharmacology trials or research activities of one or more clinical development programs as the principal investigator.
Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical pharmacology data supporting overall product scientific and business strategy.
Manages the design and implementation of multiple clinical pharmacology trials in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues.
Oversees project-related education of sub investigators, study site personnel, and AbbVie Clinical Pharmacology Research Unit (ACPRU) study staff.
Has overall responsibility for oversight of clinical pharmacology studies as the principal investigator, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule.
Along with ACPRU operations, is responsible for oversight of study enrollment and overall timelines for key deliverables.
Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
Responsible for design, execution, analysis, interpretation, and reporting of scientific content of protocols and Clinical Study Reports.
May oversee the work of Associate Medical and/or Scientific Directors, and of Clinical Scientists working on the same or related studies.
Provides in-house clinical expertise as a principal investigator or sub investigator for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects.
May participate in due diligence or other business development activity.
As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
Acts as a clinical interface and actively solicits opinion leader interactions related to healthy volunteers; partners with other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in clinical pharmacology.
Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements.
Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.