Senior Clinical Supply Project Lead

Closing date
Sep 30, 2023

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Job Description

The GCS Project Lead (PL) leads, represents, manages, and supports GCS project team and operates as single point of contact for clinical and technical teams across GDD on clinical supply strategy. The PL ensures complete project oversight in GCS and retains accountability for project deliverables.
Independently manages and has operational end to end responsibility for the assigned supply activity. Leads and manages activities and participates in cross-functional teams.

Your responsibilities include, but are not limited to:

• Represent GCS/TRD/BTDM in the GCT/ICT meeting and act as business partner to support and influence the decision-making process on the supply strategy and packaging design to be adopted in clinical trials. Attends TRD sub-team/BTDM/CMC meeting providing insights and guidance from clinical studies perspective.
• Provides early supply and financial forecast to support clinical development plan endorsement by development boards. Assess clinical development plan scenarios, converts them in demand forecast to support long term supply and capacity planning for TRD/NTO/BTDM. As business partner to the clinical teams, drive GCS assessment to support unplanned clinical study requirements.
• Leads overall clinical supply strategy in alignment with clinical and technical requirements and constraints. Assess risks & opportunities and define strategies to ensure supply continuity and increase supply flexibility and responsiveness in case of new clinical study initiatives.
• Oversees the entire E2E supply strategy (from Drug Substance to clinical sites) and reviews the planning assumption adopted in the supply plans and forecasts. Participates in the decision-making process in GCS to select the most appropriate supply model.
• Operates as first level of escalation and provide clear overview on issue, supply impact and mitigation plan to GCS management in case of supply risk / issue. Leads communication and manages stake-holder’s expectations in case of escalation.
• Oversees and endorses strategy defined by GCS in collaboration with TRD/BTDM sub-team regarding substantial regulatory changes to ensure supply compliance.
• Leads, represents, manages, and supports GCS sub-team in an indirect people management role. Assures GCS team works in agreement to the operating model and delivers results in alignment to the clinical project/study objectives. Ensures KPI / Health Indicators are achieved and act as a role model for strong team spirit and behaviors of collaboration.
• Understands and proactively manages the interactions of project, network and/or platform related activities within and outside of GCS. Acts as ambassador for GCS in TRD and clinical environment.
• Ensures overall budget adherence of the financial resources allocated to the project in GCS. Acts as point of contact for GCS Finance department, manages the budget allocated to the project and dis-cuss variation that could require additional financial resources. Leads the cost assessment of packaging, distribution, booklet, and comparator activities in case of new clinical study initiatives. Provides to GCS on time info regarding portfolio changes to allow line function to perform forward looking resources planning and allocation.

Diversity & Inclusion / EEO

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• Advanced degree in science, engineering, or relevant discipline (Ph.D., MBA or equivalent).
• 8years of practical experience in chemical / pharmaceutical industry or > 4 years of experience in field of expertise. Recognized expertise in related field.
• Thorough knowledge about the Drug Development and Clinical Supply processes. Comprehensive knowledge about project management, excellent organization, and planning skills
• Strong knowledge of relevant regulations (e.g., GMP, HSE etc.) and Novartis specific standards. Demonstrates cross-functional problem-solving and idea generation skills.
• Strong communication skills. Strong presentation skills. Advanced coaching skills. Proven leadership skills
• Excellent communication, negotiation, and interpersonal skills. Ability to work in interdisciplinary and cross-cultural teams.

Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we
achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:

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