Pipeline Medical Science Liaison
USMA
Pipeline Medical Science Liaisons (pMSLs) are key members of the US medical department. These field-based roles focus on interacting with, and supporting the needs of, investigators participating mainly in Enterprise Critical Studies. Pipeline MSLs work to communicate information and facilitate dialogue about AbbVies investigational products, and compounds in development, in a strictly scientific, non-promotional manner, and in full compliance with applicable laws and regulations, guidelines, codes of conduct, AbbVies policies and procedures (see Note below) and accepted standards of best practice.
Pipeline MSLs serve to enhance the scientific credibility of the Company with established and emerging clinical investigators as well as key scientific institutions and collaborative study groups, by supporting scientific dialogue and collaborations in the areas of research, medical and scientific exchange, including facilitation of requests for scientific and medical information. pMSLs also participate in close partnership with Site Management & Monitoring staff in the initiation, oversight, and follow-up of clinical studies. They also interface with other key members of US Medical Affairs (e.g. Medical/Scientific Directors, other MSLs, US Medical Operations), other Clinical Research functions such as Health Economics and Outcomes Research, Clinical Development, and others as appropriate – relevant to the therapeutic area for which the pMSL has responsibility and work collaboratively and cross-functionally with other in-field members while retaining functional independence. They maintain a high level of scientific knowledge to ensure credible dissemination of scientific information and informed scientific dialogue with key external stakeholders.
RESPONSIBILITIES:
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Ensure a strong medical and scientific presence for Abbvie in Enterprise Critical investigational sites and key scientific centers by the facilitation of clinical research in interventional phase 1-3 trials with Abbvie drugs, while supporting requests for medical and scientific information on products or areas of therapeutic interest to Abbvie.
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Engage with Clinical Trial Site Investigators and Staff to understand enrollment/screening barriers from a medical perspective and work with the site and AbbVie to find potential medical solutions. Aiming to support clinical trial enrollment.
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Establish and maintain a close working relationship with Site Management & Monitoring staff and partner in facilitating the initiation and conduct of prioritized Abbvie-led clinical trials.
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Provide scientific and technical leadership to ensure professional and credible relationships with investigators.
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Consult with physicians, pharmacists, and other medical professionals, in compliance with relevant laws and regulations, to refer appropriate patients to Clinical Trial sites and review clinical practice topics as requested by the investigator or referring sites.
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Act as the point of contact with thought leaders for investigator-initiated study (IIS) ideas with AbbVie pipeline assets and requests for support with the USMA TA MDs and the global medical teams as appropriate.
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Deliver credible presentations on scientific matters in the disease area of responsibility and about AbbVies pipeline to investigators in Abbvie-sponsored interventional research.
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May participate in the selection process by suggesting sites and investigator names to help identify appropriately qualified external experts the Company would wish to engage in collaborative efforts such as potential research collaborations, or educational and advisory roles (Advisory Boards, Congresses, Symposia, etc.); while ensuring a high level of scientific or educational integrity in these collaborative efforts.
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Identify opportunities for R&D collaborations with key institutions and External Experts and liaise with the Search & Evaluation team and Discovery or Clinical Development teams to facilitate further assessment.
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Facilitate medical and scientific field intelligence for example, maintain a list of investigators/potential investigators within a given TA, understand competitive research activities in active or planned study sites, generate insights from investigators on challenges and opportunities for AbbVie-sponsored clinical trials and communicate, where appropriate, within the Company.
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Attend relevant scientific meetings and Conferences and may represent AbbVie in scientific booths at congresses.
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Upon request, assist physicians with requests for access to AbbVie medicines on a named patient or compassionate use basis, subject to all applicable legal and regulatory requirements.
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May contribute to the AbbVies 1-7-5 early touchpoint process: provide insights on the current clinical practice, facilitate identification of tier 1 external experts, and provide scientific input into the future clinical development program for AbbVies pipeline assets.
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Ensure that all activities and interactions are conducted with due regard to all applicable local, global, and national laws, regulations, guidelines, codes of conduct, Company policies and accepted standards of best practice.
ACCOUNTABILITY & SCOPE:
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Support Enterprise Critical Studies related activities from a medical affairs perspective and contributing to meeting study timelines.
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Provide scientific and technical input to local AbbVie study teams, (early) brand teams and external investigators using information that has been reviewed and approved by relevant local procedures, and under the direction, governance, and oversight of the pMSLs manager, therapeutic area the USMA TA MDs and the global medical teams as appropriate. This includes working with local Medical Information teams, as appropriate, to respond to unsolicited requests for off-label information on AbbVie medicines.
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Ensure adherence to all applicable national laws and regulations, guidelines, codes of conduct, AbbVie standards, policies, and procedures.
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Develop and maintain collaborative relationships with investigators and thought leaders in the product / therapeutic area for which the pMSL has been assigned responsibility, to facilitate Abbvie research and contribute to the success of our pipeline.
Associated topics: ancmg, aoa, breast, cancer, hem onc, hematology, lah, palliative, physician md, physician md do