346663BR
Jun 07, 2022
USA

Job Description

12,000. The number of associates worldwide working together to reimagine medicine!

The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.

The ideal location for this role is the East Hanover, New Jersey site, but remote work may be possible (there may be some exceptions based on legal entity registration). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to specific to the East Hanover site for periodic live meetings will be at the employee’s expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.

The Global Clinical Supply Project Lead (PL) leads, represents, manages and supports GCS project team and operates as single point of contact for clinical and technical teams across the Global Drug Development Organization on clinical supply strategy. The PL ensures complete project oversight in GCS and retains accountability for project deliverables.
He/she will have operational end to end responsibility for assigned activity. Leads and manages all project and local network activities and participates in cross-functional teams.

Your responsibilities will include, but are not limited to:.

• Represent Global Supply Chain (GSC)/Technical Research & Development (TRD) / Biologics Technical Development & Manufacturing (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 pack-aging, 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

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

What You'll Bring to the Role:

• 5+ years of practical experience in chemical / pharmaceutical industry or > 3 years of experience in field of expertise
• Good expertise in related field. 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
• Fundamental Leadership skills.
• Very good communication, negotiation and interpersonal skills. Ability to work in interdisciplinary teams.

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!

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.


Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Global Drug Development
TECHNICAL R & D GDD
USA
East Hanover, NJ
Research & Development
Full Time
Regular
No
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346663BR

Clinical Supply Project Lead

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