Senior Clinical Supply Project Lead

**Summary**: 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. The CSPL has operational end to end responsibility for assigned activity. Leads and manages all project and local network activities and participates in cross-functional teams. **About the Role**: **Key Responsibilities**: - Represent GCS/Technical Research & Development (TRD) in the Global Clinical Trial Team (GCT) 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 meeting providing insights and guidance from clinical studies perspective. - Assess clinical development plan scenarios, converts them in demand forecast to support long term supply and capacity planning for TRD/Novartis Operations (NO). 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 End to End (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 critical issue. - 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 discuss 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. - Proactively communicate key issues and any critical topic in a timely manner to the appropriate management level and to/or any other relevant project team members. Consolidate data evaluation, propose solutions, and contribute to risk mitigation plans. - In close cooperation with the Unit Head, drive the unit long term strategic plan and its implementation. Ensure current and future needs are fully met, unit projects are assigned, adequately resources, delivered on time and in full compliance. **Essential Requirements**: - Advanced Degree in science, engineering, or relevant discipline (Ph.D., MBA or equivalent) - 8 years of practical experience in chemical / pharmaceutical industry or > 4 years of experience in field of expertise - Thorough knowledge of Drug Development processes and Clinical Supply processes - Comprehensive knowledge about project management, excellent organization, and planning skills - Strong knowledge of relevant regulations (e.g., Good Manufacturing Practice (GMP), Health, Safety & Environment (HSE) etc.). - Demonstrates cross-functional problem-solving and idea generation skills - Strong communication, presentation, and advanced coaching skills. - Excellent negotiation, proven leadership, interpersonal skills and Ability to work in interdisciplinary teams. In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. Level 5: In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 77 543,90 /year (on a full-time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies. Division Development Business Unit Sandoz Location Austria Site Schaftenau Company / Legal Entity AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No **Adjustments for Applicants with Disabilities**: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities