Pipeline Clinical Science Manager - Hematology

Job Description

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. At the Pipeline CSM level, the role additionally integrates field insights, clinical-development priorities and affiliate needs to shape Korea pipeline medical strategy from early clinical development through health authority approval, access and launch readiness.
The position will have primary responsibility for the Hematology pipeline, while supporting broader Oncology pipeline priorities as assigned, with particular attention to the scientific, diagnostic, referral and clinical-trial needs of patients with hematologic malignancies.

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. The Pipeline CSM is expected to provide senior scientific leadership across affiliate, regional and global interfaces and translate field insights into actionable recommendations, while maintaining the role’s established compliance obligations and functional independence.

RESPONSIBILITIES:
1. 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. The primary disease-area focus will be Hematology, including hematologic malignancies and relevant pipeline assets and clinical-development programs.
2. 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. At the Pipeline CSM level, this partnership also includes senior scientific input into study feasibility, site identification and
selection, recruitment strategy, and resolution of medically complex site questions, while maintaining clear boundaries from trial monitoring and operational management.
3. Provide scientific and technical leadership to ensure professional and credible relationships with investigators.
4. 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.
5. Act as the point of contact with external thought leaders to facilitate investigator-initiated study (IIS) ideas with AbbVie pipeline assets and requests for support to the local and global medical teams as appropriate. The Pipeline CSM may also serve as a senior affiliate scientific contact for broader pipeline collaborations, coordinating with regional and global medical and development teams under applicable governance.
6. Deliver credible presentations on scientific matters in the disease area of responsibility and about AbbVie’s pipeline to investigators in Abbvie-sponsored interventional research.
7. 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.
8. 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. The role also contributes strategic scientific input to protocol feasibility, country and site strategy, evidence needs and development decision-making, as appropriate.
9. Attend relevant internal and external scientific meetings and Conferences.
10. 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.
11. 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.
12. 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.
13. 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. At the Pipeline CSM level, insights from these relationships should be prioritized and translated into actionable recommendations for affiliate, regional and global asset and study teams; the role may also provide scientific coaching and best-practice guidance to Pipeline MSLs and other field medical colleagues.

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.
• Search and Evaluation team
• Regionally and HQ based Therapeutic Area medical affairs teams.
• 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 Advisor/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.
 

Qualifications

• Advanced degree (e.g. PhD, PharmD. Etc.) in a relevant scientific & biologic discipline is strongly preferred but candidates with an undergraduate degree in a relevant discipline and demonstrated experience will be considered.
• Professional experience as role of Medical affairs or in a similar field-based R&D role (Clinical trials and clinical development) for at least 8+ years. Candidates who do not fully meet the experience or leadership
expectations for the Pipeline CSM level may be considered for a Pipeline MSL or Sr. Pipeline MSL position,
with the appropriate level determined based on relevant experience, scientific expertise, demonstrated
capabilities and organizational needs.
• Strong understanding of Oncology clinical research landscape and implementation and conduct of Oncology clinical trials. The Pipeline CSM should also demonstrate the ability to connect clinical-trial execution, external scientific insights and the evolving competitive landscape with portfolio-level medical and development priorities.
• Demonstrated ability to develop and maintain excellent working relationships with both internal stakeholders and study investigators and site staff.
• Solid knowledge and problem-solving skill to advance the medical and scientific objectives of a
pharmaceutical company. For the Pipeline CSM level, this includes the ability to translate complex scientific,
clinical and field information into strategic recommendations that influence cross-functional and senior
stakeholders.
• Excellent initiative and judgement and demonstrated ability to positively represent Abbvie in a compliant manner.
• Demonstrated expertise in the scientific methods applied to clinical research and current legislative/regulatory controls applicable to this research.
• Excellent written and spoken communication and presentation skills, with a demonstrated ability to develop and maintain strong collaborative relationships with thought leaders, physicians, and other healthcare decision makers.

• Ability to engage effectively in both Korean and English with affiliate, regional and global stakeholders is expected for this role.
• A good understanding of written and oral English is desirable.
• Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

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