Group Medical Director, Immunology (Remote)

Company Description

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

Job Description

Purpose:

The primary responsibility of the GMD, Innovative Trial Designs, Immunology is to act as liaison between Product Safety Team Leads (PSTLs) for assets involved in platform studies, as well as to lead 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 GMD will lead the development of best practices in patient safety across innovative trials and ensure that appropriate safety monitoring and mitigation measures are consistently applied, where applicable.

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.
• As point of contact (POC) for complex innovative trial designs, internally communicate relevant updates to guidelines and discuss their implications for patient safety
• Expert consultant to Immunology Patient Safety physicians on the risankizumab, upadacitinib, and lutikizumab teams involved in platform programs
• Interact with safety governance for combination safety management strategy (SOPs, aggregate reports, SSL, etc.)
• Contribute to 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)
• Develop key partnerships with Clinical Development, Regulatory Affairs, and Statistics to explore innovative designs and expedite development plans in a patient centric manner.
• Contribute on an ad hoc basis to pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans
• Review Immunology platform protocols and represent Immunology Patient Safety at Therapeutic Area Protocol Review (TAPR) meetings for complex innovative trial designs to ensure that appropriate safety monitoring and mitigation measures are consistently applied across similar trials.
• Liaise with other TAs engaged in similar study designs (e.g. oncology) to ensure alignment, when possible, of processes within Patient Safety.
• Contribute to technical documents, such as PSSAPs and SAPs involving complex innovative trials and/or combination development programs
• Serve as the Immunology representative to the Platform Assimilation and Tactical Oversight (PLATO) workstream and contribute to the PSEQ playbook for platform and other innovative trials.
• Effectively manage direct reports with a view towards inspiring, coaching, developing talent, as well as succession planning.
• May be assigned or delegate due diligence activities, particularly for novel treatments being considered in combination therapy development.
• May participate on internal DMC or DSMB for platform programs if not directly involved in study conduct

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

The role can be remote in the US.

Qualifications

• MD/DO who has completed residency training and has patient management experience.
• Minimum 5-7 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
• Significant experience with oral presentations to regulators and safety governance
• Excellent technical writing skills
• Can lead in a matrix environment and work collaboratively across functions
• Fluency in English, both written and oral
• Experience as a people manager with commitment to training and development of junior-level staff, using best judgment to assure that they work with an appropriate level of autonomy.

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 insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.
• This job is eligible to participate in our long-term incentive programs

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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