Senior Medical Director, Medical Affairs - Global Dermatology

ICompany Description

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 - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio.

For more information about Abb Vie, please visit us at

The Medical Affairs organization provides patients, healthcare providers, and payers everywhere with the practical and clinically relevant information and solutions they need to use Abb Vie products safely and effectively, throughout the product lifecycle and the patient's journey.

The Senior Medical Director, Medical Affairs provides specialist medical and scientific input into core strategic and operational medical affairs activities for Abb Vie's global Dermatology portfolio such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, scientific communications, and value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities).

Works closely with commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical affairs, marketing activities (promotional material generation and product launches) and market access.

Reporting into a Therapeutic Area Lead for Dermatology New Indications, the Scientific Director works closely with research and development, commercial, and affiliate teams to evolve core medical, brand (product), and value and access strategies to support our evolving therapeutic area needs.

This position is based at our Mettawa, IL location (headquarters) and will follow a hybrid schedule of Tuesdays-Thursdays in office.

• Initiates medical affairs activities, generation and dissemination of data supporting the overall scientific strategy.
• Responsible from Medical Affairs for the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses.
• Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AE's & SAE's) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities.
• Participation in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for routine and ad hoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events (AE's) and Serious Adverse Events (SAE's) if assigned to Abb Vie conduct on clinical studies.
• 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.
• May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia. Assists with the scientific review, development, approval, execution, and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
• May interact with and coordinate appropriate scientific and medical activities with internal stakeholders (i.e., commercial, clinical operations, discovery, statistics, regulatory, etc...) as they relate to on-going medical affairs projects. Serves as the scientific team interface for key regulatory discussions.
• Provides scientific/medical education to investigators, clinical monitors, and project team members related to therapeutic area or disease specific information. Keeps abreast of professional information and…