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Clinical Supply Project Lead

vor 4 Monaten

Langkampfen T, Österreich Novartis Vollzeit

**Summary**:
**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.
- Actively participate in teams’ activities and fulfill all related tasks and responsibilities related to own field.
- Act as mentor for junior and senior associates providing coaching and technical training.

**Essential Requirements**:

- Degree in science, engineering or equivalent.
- >5 years of practical experience in chemical / pharmaceutical industry or > 3 years of experience in field of expertise
- Good knowledge of Drug Development processes
- Project management, good organization, and planning skills
- Knowledge of relevant regulations (e.g. Good Manufacturing Practice (GMP), Health, Safety & Environment (HSE) etc.).
- Demonstrates problem-solving and idea generation skills
- Good presentation skills and fundamental Leadership skills.
- Communication, negotiation, and interpersonal skills. 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 4: 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 €60,212.18/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.

**Commitment to Diversity and Inclusion**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Division

Development

Business Unit

Pharmaceuticals

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 we serve.