Clinical Scientific Expert Group Head

3 weeks 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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