Associate Medical Director, Innovative Trial Design, Immunology; Remote

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, as well as products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on Twitter, Facebook, Instagram, You Tube and Linked In.

Purpose:

The primary responsibility of the AMD, Innovative Trial Designs, Immunology is to support the overarching safety strategy for innovative study design concept and execution in immunology development programs. In lieu of primary safety responsibility for an asset or group of assets, the AMD will collaborate with the Group Medical Director to develop best practices in patient safety across innovative trials, support platform program teams, and help ensure that appropriate safety monitoring and mitigation measures are consistently applied.

Responsibilities:

• Understand and apply concepts in mechanisms of action in immunology, pharmacology, and non-clinical toxicology to inform safety surveillance and mitigation measures in clinical trials.
• Maintain knowledge of applicable regulations and guidelines regarding the design and conduct of complex innovative trials.
• Conduct periodic reviews of the scientific literature regarding platform and innovative study design and make recommendations to the immunology platform study teams regarding patient safety monitoring and mitigation measures consistent with precedence and current regulatory guidelines.
• Support the combination safety management strategy (SOPs, aggregate reports, SSL, etc.) and liaise with other TAs engaged in similar study designs (e.g., oncology) to ensure alignment, when possible, of processes within Patient Safety.
• Support Health Authority interactions regarding safety monitoring in the planning of innovative trial design protocols (e.g., implementing stopping rules, appropriate mitigation measures, and planning for seamless adaptations based on benefit-risk assessments).
• Contribute on an ad hoc basis to pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, and risk management plans.
• Contribute to technical documents, such as PSSAPs and SAPs involving complex innovative trials and/or combination development programs.
• May serve as delegate for the Group Medical Director on the Platform Assimilation and Tactical Oversight (PLATO) workstream and contribute to the PSEQ playbook for platform and other innovative trials.

Significant Work Activities:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.

Frequent to continuous computer usage (greater or equal to 50% of the workday) is required.

Qualifications:

• MD/DO with 2+ years patient care experience strongly preferred.
• Minimum 2 years experience in drug safety or a related discipline in the pharmaceutical industry.
• Clinical trial experience strongly preferred.
• Excellent clinical judgment and ability to make independent decisions under uncertain and complex circumstances.
• Demonstrated track record of being an innovator or a change agent is a plus.
• Strong technical writing skills.
• Demonstrated ability to work collaboratively across functions.
• Fluency in English, both written and oral.

Additional Information:

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range.
  
  This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision…