Head, Clinical Development Business Solutions

12 hours ago

East Hanover, United States Novartis Group Companies Full time

Job Description Summary

Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people‘s lives.

To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic areas and platform depth and capabilities - all to bring our medicines to patients even faster.

We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to.

Apply today and welcome to where we thrive together


Job Description

The Role:Are you ready to become the Head, Clinical Development Business Solutions? This role will be working closely with the Global Head CD Program Scientific Excellence as well as the Global Head CD to drive functional excellence and execution for the Clinical Development function. This all sits within the heart of where Novartis clinical development processes are owned and managed and guiding teams on how we run trials. The Business Solutions function has oversight of Clinical Development Plan, Study Protocol, SOPs, templates, systems, tools, inspection readiness and guiding teams on how we approach our trials. You will be process driven, have a quality mindset and will be involved in something very real and rewarding. So, if you are an inspiring leader, rigorous in your detail, have experience working across a network of experts to drive success - then this is the job for you.Major accountabilities but not limited to:
  • Drives the operational execution of CD owned functional and cross-functional processes; develops and oversees compliant and efficient approaches to ensure Clinical Development excellence
  • Assumes oversight of all Clinical Development-owned processes and their related systems, tools, templates, guidance documents, and standard operating procedures.
  • 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
  • Acts as sponsor and business owner of Clinical Development required tools and systems and their enhancements.
  • 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 processes based on performance metrics and corrective actions, utilizing new technologies and insights from cross-industry forums.
Key Performance Indicators:
  • Achieves overall goals as defined each year by the Global Head CD and Global Head, CD Program Scientific Excellence
  • Defines and implements a culture of ‘operational excellence & solutions‘ both within the CD organization and in line with the broader Development organization
  • Successful people management of team members within CD Business Solutions
Education and experience:
  • Advanced degree in a scientific or healthcare field is required.
  • Fluent in English
  • 10+ years relevant industry experience with a fundamental understanding of Drug Development
  • 10+ years multi / cross functional global leadership experience desired
  • 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
  • Excellent understanding of clinical development, quality and regulatory standards and policies
  • Well-established track record and sought after across the industry for strong Drug Development and organizational leadership. Proven ability to effectively lead or sponsor major non-clinical initiatives
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? about/strategy/people-and-cultureCommitment to Diversity & Inclusion:Novartis is committed to building an outstanding, inclusive work environment and diverse team‘s representative of the patients and communities we serve.Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: network


Skills Desired

Budget Management, Clinical Trials, Coaching, Compliance, Cross-Functional Teams, Leadership, People Management, Risk Management, Risk Monitoring, Strategy

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