Summary
ROLE TYPE: Hybrid Working
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. Responsible for driving the strategy, development and execution of Clinical Scientific Excellence
in compliance with Novartis processes, ICH GCP and regulatory requirements. The Group Head reports to Head CSE and support Senior Leaders from the business and functions within Global Drug Development (GDD) to help to progress how Novartis innovates, engages and operates. The Development Units will be a key stakeholder and interactions will primarily focus on CSE support of Clinical Trials. Drives cultural change in the company, direct, oversee and coordinate all activities, deliverables and resources within CSE group and Development unit(s). The CSE role applies the principles of clinical data review excellence and identifies clinical data insights to ensure data is scientifically plausible and to identify trends, signals and risks associated to trial endpoints and patient safety. The Group Head is expected to act as a leader on any cross-organizational governing body on clinical data review strategies through local and global level initiative.
About the Role
Job Responsibilities:
- Accountable for Leadership and Management of Clinical Scientific Experts (CSE I/II):
- Selects, recruits, develops, manages, motivates, coaches and appraises the performance of direct reports.
- Manages and coordinates the assignment of resources and workload.
- Provides all necessary support to help address and resolve issues.
- Builds and establishes a strong team spirit.
- Leads and supports special projects and training.
- May act as a Subject Matter Expert.
- Manages audits and inspections.
- Promoting cultural change:
- Drive development of a change management concept.
- Coach CSE I and CSE II to ensure high quality clinical trial data and CSRs.
Education:
- Advanced degree in life sciences/healthcare.
Experience:
- Experience in multi-national organization.
- 3+ years in scientific/strategic/operational experience.
- 5+ years in Clinical Operations/Scientific roles.
- Knowledge of trial design, stats, regulatory processes.
- Scientific expertise.
- Data collection and analysis skills.
- Analytical background.
- Leadership skills.
- Project management experience.
- People management.
- Communication skills.
- Leadership.
- Work under pressure.
- Negotiation and conflict resolution.
- GCP, clinical trial knowledge.
- Scientific writing.
- Proactive, result-driven.
- Decision-making.
- Problem-solving.
- Quick action taker.
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
