Medical Director/Senior Medical Director, Immunology Clinical Development - Respiratory

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

With supervision, oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and businessstrategy.

Responsibilities

• Withappropriate supervision, manages the design and implementation of study protocols for a clinical development program in support of the 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 investigators, study site personnel, and AbbVie study staff.
• Has responsibility for oversight of clinical studies,monitoringoverall study integrity, and review, interpretation, and communication of accumulating datapertaining tosafety and efficacy of the molecule.Along with Clinical Operations,is responsible foroversight 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.
• Contributes to design, analysis, interpretation, and reporting of scientific content of 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 the protocols for which the incumbent has responsibility.Contributes to the development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan in collaboration with matrix team members.
• Participatesin opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities asrequired, consistent with corporate policies.
• Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augmentexpertisein the therapeutic area.
• Responsible for understanding the regulatory requirements related tothe clinicalstudies and global drug development and accountable forcomplying withthose requirements. May be asked to contribute to regulatory responses and discussions.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

Qualifications

Medical Director Qualifications

• Medical Doctor (