Purpose:

Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica, Venclexta, and Empliciti — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.  AbbVie is expanding its oncology early development pipeline.  More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these sites. They combine their expertise in small molecules, immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments.  

In Oncology Early Develoment, the Senior Clinical Trial Leader (CTL) is responsible to connect science and operations to bring clinical studies to life through the execution of one or more early phase oncology clinical research studies. Contributes clinical operational strategies to ensure clinical research studies are executed with quality and efficiency, on-time, within budget, and meet company objectives. The Sr CTL achieves these objectives via scientific expertise, strategic thinking, a global mindset and innovative solutions to address risks and challenges.

Responsibilities:

•Responsible for executing clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).
•Leader of the cross functional study team: o Leads Clinical Study Team Meetings  o Project manager for clinical studies leveraging the clinical schedule; manages the critical path and milestones
•Responsible for the vendor/CRO selection, scope development, management and oversight of external vendors/CROs in compliance with AbbVie’s processes and procedures and the applicable regulations

•Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies

•Responsible for regular updates to the cross-functional team and stakeholders on study status; ensures our CTMS is up to date   Responsible for regular updates to the cross-functional team and stakeholders on study status; ensures our CTMS is up to date
•Responsible for the development of the clinical study design and associated systems and documents (for example: Informed consent forms, eCRFs, IRT, CSR) Responsible for study budget creation and oversight of spend against approved budget
•Proactively identify and address and/or escalate study related issues and opportunities for efficiency  Decision maker on operational aspects of study execution Participates in innovation and process improvement initiatives
•Provides direct supervision of study management associate(s) including career development of clinical operations staff and creating an inclusive and innovative environment where staff and studies/programs will succeed

This role can be hired at a Sr. Clinical Trial Leader or a Clinical Trial Leader level, dependent on years of relevant experience; previous work, education, training, and clinical research capabilities 

Qualifications for Sr. Clinical Trial Leader:

•Bachelor’s Degree or OUS equivalent degree is required, typically in nursing or scientific field; Registered Nurse licensure with Associate’s Degree in Nursing with relevant experience is also acceptable.
•Must have at least 8 years of Pharma-related/clinical research related experience.
•Strong background leading oncology clinical trials

•Experience overseeing fully outsourced clinical trials or experience at a CRO

•Must have demonstrated a high level of core and technical competencies through management of clinical trials.
•Possess good communication skills and demonstrated leadership abilities.
•Demonstration of successful coaching and mentoring in a matrix environment; direct people management preferred.
•Considered a subject matter expert and competent in the application of Standard Business Procedures (International Conference on Harmonization, Global Regulations, Ethics and Compliance).
•Experience in successful study initiation through study completion, primary data analysis and/or in multiple phases of studies (Phase 1-3, 4).

Qualifications for Clinical Trial Leader:

•Bachelor’s Degree or OUS equivalent degree is required, typically in nursing or scientific field; Registered Nurse licensure with Associate’s Degree in Nursing with relevant experience is also acceptable.
•Must have at least 6 years of Pharma-related/clinical research related experience.

•Strong background leading oncology clinical trials

•Experience overseeing fully outsourced clinical trials or experience at a CRO
•Demonstrates a high level of core and technical competencies through management of various components of clinical trials.

•Possesses good communication skills and demonstrated leadership abilities.
•Demonstration of successful coaching/mentoring in a matrix environment.
•Competent in application of standard business procedures (Standard Operating Procedures, International Conference on Harmonization (ICH), Global Regulations, Ethics and Compliance).
•Preferred exposure in study initiation through study completion in multiple phases of studies.