Head, Clinical Development Business Solutions
Job ID: REQ-10023111
Date: Oct 10, 2024
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.
This role will be based in Basel, Switzerland in a hybrid working approach.
About 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.
* 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.
Commitment to Diversity & 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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