Clinical Supply Project Lead
Vor 2 Tagen
125,000 That's the number of unique individuals working at Novartis, all with different needs and aspirations, aligned to a single inspirational purpose; to Reimagine Medicine for millions of patients around the world
- Your Responsibilities:
- 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 embraced 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 and ensure overall budget adherence of the financial resources allocated to the project in GCS.
- 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.
- Coordinates 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 stakeholder’s expectations in case of escalation.
- Coordinates 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 teamwork.
**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._
**Minimum requirements**
- Minimum requirements:
- What you’ll bring to the role:
- Degree in science, engineering or equivalent, as well as proficiency in English
- 5+ years of practical experience in chemical / pharmaceutical industry or > 3 years proven experience in field of expertise
- Strong stakeholder engagement skills as well as good knowledge about the Drug Development process
- Basic project management, good organization and planning skills
- Knowledge of relevant regulations (e.g. GMP, HSE etc.) and Novartis specific standards.
- Demonstrates problem-solving and idea generation skills, good presentation skills, as well as fundamental Leadership skills.
Why Novartis?
- 766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
- We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
- We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
- Imagine what you could do here at Novartis
**Division**
- Global Drug Development
**Business Unit**
- TECHNICAL R & D GDD
**Country**
- Switzerland
**Work Location**
- Basel
**Company/Legal Entity**
- Novartis Pharma AG
**Functional Area**
- Research & Development
**Job Type**
- Full Time
**Employment Type**
- Regular
**Shift Work**
- No
**Early Talent**
- No
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