Scientific Director, Psoriatic Disease Medical Affairs

Company Description
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  Follow @abbvie onLinked

In,Facebook,Instagram,Xand You Tube .

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 Scientific Director / Senior Medical Director provides specialist medical and scientific leadership for Abb Vie's Psoriatic Disease portfolio. This role is accountable for developing and executing Global Medical Affairs strategy, driving scientific excellence across all medical affairs activities (HCP interactions, data generation, educational initiatives, and safeguarding patient safety), and serving as the key internal medical expert for the therapeutic area.

This role partners cross-functionally with Commercial, HEOR, Regulatory, Clinical Development, and Market Access teams, while maintaining accountability for compliance, patient safety, and scientific integrity.

Position will be based from our Mettawa, IL headquarters site following a hybrid schedule of 3 days/week in office. Other major U.S. R&D sites may potentially be considered for highly experienced talent (Florham Park, NJ or San Francisco, CA).

• Initiates medical affairs activities including data generation and dissemination strategy, development of Global Medical Affairs strategy, delivering the Medical Functional Plan, and the Brand Plan. Works closely with Area and Affiliates to ensure consistent global execution of medical strategy. Contributes to the development of HEOR evidence strategies to support value proposition, market access, and payer engagement for the portfolio.
• Responsible as Medical Affairs for the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, and Regulatory Submissions and responses.
• Has overall responsibility for oversight of the Medical Affairs-led clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific activities with internal stakeholders and leadership as they relate to ongoing clinical projects.
• M.D.s may participate in design and execution of clinical trial safety; scientifically accountable for resolution of safety issues, safety monitoring, and other scientific reports reported to regulatory authorities. Review and assess all Adverse Events (AE’s) and Serious Adverse Events (SAE’s).
• Acts as a clinical interface and actively solicits opinion through leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and 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.
• Plans and executes scientifically accurate marketing materials, medical education programs, Medical Advisory Boards, and scientific symposia. Assists with the scientific review, development, approval, execution, and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
• Interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e., commercial, market access, HEOR, clinical operations, clinical development, regulatory, etc…) as they relate to on-going medical affairs projects. Serve as the scientific team interface for key…