- Position: Pipeline Clinical Science Manager, Immunology
- Reports to: Therapeutic Area Head, Immunology
- Location: Seoul, South Korea
PRIMARY FUNCTION
Clinical Science Manager (CSM) are key members of the affiliate medical department. These field-based roles focus on interacting with, and supporting the needs of, investigators participating in priority sponsored studies. Clinical Science Manager (CSM) work to communicate information and facilitate dialogue about AbbVie’s investigational products, and compounds in development, in a strictly scientific, non-promotional manner, and in full compliance with applicable national laws and regulations, guidelines, codes of conduct, AbbVie’s policies and procedures (see Note 1, below) and accepted standards of best practice.
Clinical Science Manager (CSM) 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. Clinical Science Manager (CSM) also participate in close partnership with affiliate-based Site Management & Monitoring staff in the initiation, oversight and follow-up of clinical studies. They also interface with other key members of the affiliate medical department - for example: Medical Managers, Medical Advisers, Clinical Research Managers and functions such as Health Economics and Outcomes Research, Market Access and others as appropriate - relevant to the therapeutic area for which the Clinical Science Manager (CSM 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.
Notes:
1. An Acceptable Practices Policy exists in all affiliates, and governed by the Affiliate Compliance Committee, to describe activities permitted by this role.
2. This Job Description does not apply to those employees whose primary job function relates to the monitoring or management of clinical studies.
JOB RESPONSIBILITIES:
- Ensure a strong medical and scientific presence for Abbvie in investigational sites and key scientific centers by facilitation of clinical research and of 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
- 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 through site feasibility assessment, site engagement and training, defining recruitment issues and answering query from the sites.
- Provide scientific and technical leadership to ensure professional and credible relationships with investigators.
- Consult with physicians, pharmacists, and other medical professionals to refer appropriate patients to Clinical Trial sites and review clinical practice topics as requested by the investigator or referring sites.
- Act as the point of contact with external thought leaders to facilitate Sponsor-initiated study (SIS) ideas with AbbVie pipeline assets and requests for support to the local and global medical teams as appropriate.
- Deliver credible presentations on scientific matters in the disease area of responsibility and about AbbVie’s pipeline to investigators in Abbvie-sponsored interventional research.
- Participate in the selection process to 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.
- Identify opportunities for R&D collaborations with key institutions and thought leaders and liaise with the Search& Evaluation team and Discovery or Clinical Development teams to facilitate further assessment.
- 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.
- Attend relevant internal and external scientific meetings and Conferences.
- 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.
- For countries involved in the 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 AbbVie’s pipeline assets.
- Develop the long-term medical strategy and plans proactively from clinical trials to HA approval and access of pipeline assets and carry out medical engagement accordingly based on the medical insight to conduct the work macroscopically with continuity.
- 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:
- 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 MSL’s manager, therapeutic area Medical Manager, or Affiliate Medical Director as appropriate. This includes working with local Medical Information teams, as appropriate, to respond to unsolicited requests for off- label information on AbbVie medicines.
- Ensure adherence to all applicable national laws and regulations, guidelines, codes of conduct, AbbVie standards, policies, and procedures.
- Develop and maintain collaborative relationships with investigators and thought leaders in the product / therapeutic area for which the Clinical Science Manager (CSM) has been assigned responsibility, to facilitate Abbvie research and contribute to the success of our pipeline.
INTERNAL / EXTERNAL CONTACTS AND INTERACTIONS:
- Affiliate medical personnel: Clinical Research Associate, Local Study Representative, Clinical Operations Manager, Medical Managers/Advisers; Medical Information team / specialists; affiliate pharmacovigilance / drug safety personnel
- Market access teams incl. HTA teams; Affiliate Early Brand teams.
- Affiliate Government Affairs; Affiliate Public Affairs; Regulatory Affairs; Legal; OEC.
- Global Medical Information team
- Search and Evaluation team
- Regionally and HQ based Therapeutic Area medical affairs team
- Project/Medical Directors and Clinical Teams within Pharmaceutical Development and Global Medical Affairs
- Healthcare personnel (including physicians, nurses, pharmacists)
- Participating Research Investigators; thought leaders/external experts
- Institutions and Scientific or Medical Societies
- Hospitals, other healthcare providers, payers and Local Regulatory Authorities
- AUTHORITY AND REPORTING LINES:
- This position typically reports into the Group Medical Manager/Medical Manager/TA Lead, however reporting lines may vary from country to country.
LOCATION:
- This function is typically field based. Typically, up to 20% of an individual’s time may be spent working in the affiliate medical team head office – the remainder of time being spent as field based. This is subject to local needs, and the discretion of the affiliate medical director.