Your Key Responsibilities:

• Assumes oversight of all Clinical Development-owned processes (e.g., Clinical Development Plan, Study Protocol, Clinical Data Review, Medical Devices in Clinical Trials, Investigators Brochure, Data Monitoring Committee, Steering Committee, and others) and their related systems, tools, templates, guidance documents, and standard operating procedures.
• Leads the Business Solutions team of Clinical Development process owners, by providing day-to-day guidance, talent management, career development, and succession planning activities. Attracts, develops, coaches, motivates, and retains top talent, building a leadership and skills pipeline for the future.
• Builds, promotes, and maintains partnerships with Global Clinical Operations, Advanced Quantitative Science, Quality, and other key Novartis divisional stakeholders. Ensures collaboration on key initiatives and defines proactive cross-functional operational plans to mitigate/manage operational and inspection risks
• Oversees the cross-functional deployment of Risk-Based Quality Management for Clinical Development and partner functions.
• Accountable for ensuring clinical trial teams are trained on Clinical Development-owned processes, guided in day-to-day activities, and supported during inspections and audits. Functional Process Owner, reporting to the Head of Business Solutions, is responsible for presenting and defending the end-to-end process to Health Authorities and inspectors.
• Ensures constant improvement of Clinical Development processes based on performance metrics and corrective actions, utilizing new technologies and insights from cross-industry forums (e.g., Transcelerate).
• Ensures that Clinical Development processes adhere to regulations (e.g., ICH guidelines, HA guidelines/regulations, ISO, etc.) and oversees quality and compliance in Clinical Development. This includes tracking process deviations, completing CAPAs, assigning GxP training, and addressing identified risks and gaps.

Video Link http://www.youtube.com/watch?v=ggbnzRY9z8w  

Role Requirements:
Essential Requirements

• PhD or equivalent advanced degree in a scientific or healthcare relevant field with 10+ years pharma industry experience.
• Advanced knowledge of Clinical Development grounded on hands-on experience in phase 2/3 clinical trials.
• Strong leadership presence with the ability to present and interact with senior management.
• Strong evidence of strategic thinking, problem solving capabilities, scenario evaluation, contingency planning and operational effectiveness/innovation, especially in drug development.
• Deep understanding of GCP and regulatory standards and policies.
• Strong project management skills, able to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude.
• Proven track record in working across a matrix organization and demonstrating expert skills in building partnerships and negotiating agreements; Excel at collaboration.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? http://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards

Commitment to Diversity & Inclusion: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

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