
Sso Hub Head Portfolio
4 days ago
Critères de l'offre
**L'entreprise**: Novartis
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.
Description du poste
**Job Description**:
The SSO (Study & Site Operations) Hub Head Portfolio is accountable for the oversight and project management of the clinical trials execution across the entire GDD (Global Drug Development) portfolio within assigned Hub, in collaboration with the SSO Country/Cluster Heads Portfolio as well as the other Hub Heads Portfolio and in compliance with Novartis processes, GCP/ICH and regulatory requirements.
- In alignment with GCO (Global Clinical Operations) strategy, responsible for the successful planning and delivery of the portfolio at Hub level.
- Supports the development of the long-term portfolio/program and/or indication level operational plans, bringing hub level inputs into the global disease area strategies
- Translates global strategy into concrete steps for hub operational implementation
- Collaborates with the key stakeholders (e.g., PSP (Program Strategy & Planning) Leads, Study Leaders, Country/Cluster Portfolio Heads, Medical Directors/CSOs) to ensure execution of portfolio objectives for the hub, prioritization, and tracking, including identification of key hub portfolio risks and opportunities
- Identifies synergies and potential competition within portfolio at the Hub level and addresses with Country Organizations to ensure efficient and effective delivery of GLT, GDD and GCO objectives. Align with peers from other hubs to ensure global coverage of risks and opportunities.
- Drives proactive risk management and contingency planning within the hub and communicates program status with the respective stakeholders in a transparent and timely manner.
- Collates, analyzes, and provides documented and robust hub risk assessment on portfolio deliverables together with the other Hub Heads Portfolio, to identify root causes, and attain an aligned cross functional and cross hub risk status
- Responsible to ensure the quality and accuracy of the portfolio key milestones and data leveraging platforms and systems (e.g., CTMS, SENSE). Provides directions, user requirements and critical views to ensure systems are fit for purpose.
Description du profil
Minimum Requirements
- Minimum requirements: College or university degree with significant life science experience
- Fluent in both written and spoken English
- At least 8 years' experience in clinical research, in planning/executing and/or monitoring clinical trials
- Solid understanding of all aspects of clinical drug development with particular emphasis on clinical trial design, trial execution, project management and operations
- Thorough knowledge of the international aspects of drug development process, the international standards (GCP/ICH), health authorities (FDA/EMA), local/National health authorities' regulations, Novartis standards, and clinical development process
- Demonstrated ability to develop operational strategies in collaboration with partner functions in a matrix environment
- Proven ability to manage operational challenges at global, hub and/or country level
- Superior project management capabilities with demonstrated ability to problem solve and mediate complex issues
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