Medical Director, Hematology Clinical Development

About Abb Vie

Abb Vie'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 Abb Vie, please visit us at  Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.

Abb Vie'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 Abb Vie, please visit us at  Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.

Purpose:

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 business strategy.

Responsibilities:

• Manages the design and implementation of one or more clinical development programs in support of an overall Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, Abb Vie’s customers, markets, business operations and emerging issues. Oversees project-related education of investigators, study site personnel and Abb Vie study staff. Responsibility may extend from early translational development activities to mature product lifecycle management strategies for internal and/or partnered programs.
• Has overall responsibility for oversight of clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical 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, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents.
• May oversee the work of Associate Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.
• Provides in-house clinical expertise 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.
• May serve on or chair a Clinical Sub-team, or it’s equivalent with responsibility for development of a rigorous, cross-functionally-aligned, vetted Development Plan with full consideration of contingencies and alternative approaches. In the role as lead of the Clinical Sub-team (or it’s equivalent), responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to an Asset Strategy Team (AST), AST Leadership Board (ALB) and/or other cross-functional teams and…