The incumbent is the internal scientific expert in the disease area and scientific aspects of the competitive landscape. The Clinical Scientist is accountable for ensuring the medical/scientific validity and integrity of the clinical development program and study protocols.
S/he plays a key role in supporting clinical study planning and execution through the development starting with the creation of the Clinical Development Plan (CDP) and clinical study protocol synopsis, input into the clinical study protocol and Clinical Study Report and Clinical sections of the CTD for regulatory submissions, while working collaboratively with the cross-functional Clinical Team to assess study data, integrate summaries of safety and efficacy, risk / benefit assessments, etc. This information is incorporated into Agency briefing packages, Investigator Brochures, and regulatory documents, including the clinical modules for submissions.
In addition, the incumbent is the key contact for relationships to external experts/ Key opinion leaders and provides regular scientific-medical disease state updates, etc.
The incumbent is responsible for the leadership and the results of the clinical team throughout the Global Clinical Development process. The Clinical Lead represents the clinical team in the core project team.
The incumbent has overall responsibility for ensuring the development and execution of the clinical strategy. This includes responsibility for the clinical team’s creation of relevant documents and outputs including Clinical Development Plan (CDP), clinical program feasibility, Investigator’s brochure, study protocol synopsis, clinical study protocols, top line study data communication plan, Clinical Study Report (CSR), clinical sections of regulatory documents including the clinical sections of the CTD for regulatory submissions, and planning of the Annual reports together with Regulatory affairs and respective clinical team members. S/he ensures alignment of the CDP with the Global Development Plan (GDP). In addition, working collaboratively with the Program Operations Lead, the Clinical Lead oversees achievement of all activities related to the Clinical development program, including achievement of key program milestones within the planned time lines and budget. The Clinical Lead is accountable to the Project Core Team for the Clinical Development budget.
Global Project Team Lead
The Incumbent is responsible for the leadership and results of a cross functional global project development team throughout the Global Development process.
In collaboration with the core project team members and the departments involved, the incumbent leads the synthesis of the project development strategy, contingency plans, tactics, budgets, timelines, milestones and submission targets into the Global Development Plan (GDP).
S/he is accountable for securing Senior Management approval to the project strategy including timelines and budgets, as well as the execution of the plan through leveraging the Global Development organization and other functions (e.g. Regulatory Affairs, Global Health Outcomes). The Global Project Leader is accountable to manage the project through the development stage gates, and to lead the Project Core Team to reach decisions and recommendation at each stage gate, including revisions to the development plan, timelines and budget if indicated. Moreover, s/he has the overall responsibility for delivering the project’s regulatory submissions objectives.
Based on the agreed GDP, and in collaboration with Project Management and the core project team, the Global Project Lead sets development milestones and budget targets for the core team which are also cascaded to all related sub-teams to ensure that goals are aligned, and budgets are met. The Global Project Lead will set the core team member’s project goals and is responsible for conducting their performance evaluation with the aspects of these goals.
The Global Project Leader will provide oversight of the evolution of the project’s Risk Management plan through all stages of Development.
The Global Project Leader may also lead Agency interactions in partnership with Regulatory Affairs.
General Compliance and Other Role(s)
The incumbent is responsible for adherence to all relevant regulations e.g.: ICH, PhRMA and CFR guidelines, as well as AbbVie's policies, SOPs and Work Instructions. Ongoing training in compliance areas and therapeutic specific knowledge is expected in order to maintain a solid knowledge base for performing assigned tasks. Provide strategic and/or technical consultations on behalf of the therapeutic area (e.g., study design, business development, marketing, communications, training, legal, etc.)