Clinical Scientific Expert Group Head

5 days ago

Dublin, Ireland Healthcare Businesswomen’S Association Full time

Job Description Summary
The CSE Group Head (CSE GH) supervises Clinical scientific experts (CSE I/ CSE II).
Responsible for competency building of the team by coaching the Clinical Scientific Expert.
The CSE GH facilitates their allocation across Development Programs/ Brands for planning and tracking all activities pertaining to one or more Development Programs/ Brands.
Responsible for allocating/ balancing resources aligning with Clinical Development Functional Heads (CD-FH), Global Program Clinical Heads (GPCH), Therapeutic Areas Heads (TA Heads) and based on the Development Unit/portfolio needs.
Job Description
Key responsibilities:
Selects, recruits, develops, manages, motivates, coaches, and appraises direct reports to ensure high-quality performance and career development.
Manages resource assignments, workload distribution, and sharing within groups to meet company objectives and priorities.
Provides support to address and resolve issues, identifying solutions for remediation.
Builds a strong team culture focused on expertise, performance, and alignment with Novartis values and behaviors.
Leads special projects, initiatives, and supports training programs for technical and professional skills within the team.
Acts as a Subject Matter Expert for key operational areas influencing the Clinical Scientific Expert Group and broader clinical development.
Collaborates with QA on audit readiness, regulatory inspections, and Health Authority compliance.
Promotes cultural change and integrates change management concepts aligned with Novartis objectives, focusing on data-centric mindset and capability building.
Essential requirements:
Advanced degree in life sciences/healthcare (e.g., PharmD, PhD, MD, etc.) preferred; experience in multinational organizations required.
=3 years experience in clinical study planning, execution, and publishing in industry/Academia, or 5+ years in Clinical Operations/Scientific roles; team/matrix management experience preferred.
Strong understanding of trial design principles (e.g., objectives, bias reduction, statistical methods, ethics) and clinical development processes, including GCP knowledge.
Thorough knowledge of clinical data collection/reporting systems (e.g., EDC tools, Rave, OC-RDC); ability to analyze trends and interpret/report data effectively.
Medical/scientific expertise with strong writing skills; capable of interpreting, discussing, and representing trial/program data.
Demonstrated leadership, planning, and people management skills, including mentoring/coaching within matrix environments.
Analytical background with proficiency in statistical methods; experience detecting data trends and escalating issues appropriately.
Strong interpersonal, communication, and problem-solving skills; ability to collaborate across boundaries for shared success.
Skills Desired
Budget Management, Clinical Research, Clinical Trial Protocol, Clinical Trials, Coaching, Cross-Functional Teams, Data Analysis, Learning Design, Lifesciences, Risk Management, Risk Monitoring
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