You will lead the clinical supply strategy by managing forecasting, stakeholder communication, and budget adherence. This role requires collaboration with the Global Clinical Trial Team to ensure effective and timely supply management.
Anforderungen
- •Advanced Degree in science or engineering
- •More than 8 years experience in chemical industry
- •Thorough knowledge of Drug Development processes
- •Comprehensive knowledge about project management
- •Strong knowledge of Good Manufacturing Practice
- •Demonstrates cross-functional problem-solving skills
- •Strong communication and advanced coaching skills
- •Excellent negotiation and leadership skills
Deine Aufgaben
- •Represent GCS in the Global Clinical Trial Team.
- •Influence supply strategy and packaging design decisions.
- •Assess clinical development scenarios and forecast demand.
- •Drive GCS assessment for unplanned clinical study requirements.
- •Lead clinical supply strategy in alignment with requirements.
- •Assess risks and define strategies for supply continuity.
- •Oversee the End to End supply strategy planning.
- •Review planning assumptions in supply forecasts.
- •Serve as first level of escalation for supply issues.
- •Provide overview and mitigation plans to management.
- •Manage stakeholder expectations during critical issues.
- •Act as ambassador for GCS in clinical environments.
- •Ensure budget adherence for projects in GCS.
- •Manage allocated financial resources and discuss variations.
- •Lead cost assessments for clinical study initiatives.
- •Inspire and coach team members as a subject matter expert.
- •Communicate key issues to management and project teams.
- •Propose solutions and contribute to risk mitigation plans.
- •Drive long-term strategic planning with Unit Head.
Deine Vorteile
Market-competitive base salary
Attractive incentive program
Modern company pension scheme
Childcare facilities
Learning and development opportunities
Worldwide career possibilities
Minimum salary disclosure
Original Beschreibung
# Senior Clinical Supply Project Lead
**Schaftenau** | **Full time**
**Band**
Level 5
**Job Description 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.
**Job Description**
**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.
* Inspire/coach/lead team members. Provide coaching and technical training as subject matter expert or recognized technical expert. Act as a mentor for junior and senior associates globally.
* 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.
**Skills Desired**
Continual Improvement Process, Master Data, Material Requirements Planning (Mrp), Materials Management, People Management, Production Planning, Supplier Relationship Management (Srm), Supply-Chain Management, Supply Chain Planning, Technical Requirements, Waterfall Model, Wms (Warehouse Management Systems)