346678BR
Jun 23, 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 GCS (Global Clinical Supply) Clinical Trial Supply Manager (CTSM) defines and executes an optimal clinical trial supply strategy for a clinical trial including effective risk management to ensure supply continuity to patients.
The CTSM is the GCS single point of contact at trial level for the integrated Clinical Trial Team (iCTT). Is responsible for clinical trial supply deliverables within GCS and all other relevant associated sub-functions, maintaining Quality and Compliance through all activities.
Has 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:

• Represents GCS as a core member in the integrated Clinical Trial Team (iCTT); defines and advises the iCTT on the optimal clinical trial supply strategy in terms of, but not limited to, packaging design, technical and timeline feasibility, efficiency and risk management.
• Reviews overall clinical trial protocol/protocol amendments, provides inputs to develop optimal packaging design, clinical trial supply design and visit schedule.
• Creates and maintains complete and accurate clinical supply demand for assigned study in alignment with protocol requirements, key study parameters and milestones, patient projections, with appropriate overage and by using defined processes and systems.
• Creates and drives finalization of the packaging design (Clinical Packaging Request) and a comprehensive label strategy for all participating countries in the clinical trial.
• Defines clinical supply parameters for NIRT set up and initiates subsequent updates through-out the duration of the clinical trial
• Develops and executes a trial-level project plan together with all other relevant roles.
• Identifies, assesses and proactively communicates supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity
• Collaborates with all relevant line function partners for country submission and approval time-lines (including IND-IMPD amendment) to develop optimal supply strategy.
• Generates optimal distribution plans for investigational medicinal products (IMPs), jointly with partner functions. Triggers and tracks shipments of IMPs from central depot to regional hubs and local depots.
• Develops, maintains and executes an optimal resupply strategy with proactive planning, ap-propriate lead-time and replenishment quantities to ensure compliance and continuity of clinical supplies, including proactive expiry management of clinical supplies.


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:

• Bachelors Degree science, engineering or related field
• 5+ years of practical experience in chemical / pharmaceutical industry or > 3 years of experience
• Industry level knowledge on the drug development process
• Basic project management, organization and planning skills
• Knowledge of relevant regulations (e.g. GMP, HSE etc.) and Novartis specific standards.
• Demonstrates problem-solving and idea generation skills
• Ability to provide concise communicate cross-functionally and present findings, data etc to peers and colleagues
• Robust, negotiation and interpersonal skills with the ability to work in interdisciplinary teams.
Global Drug Development
TECHNICAL R & D GDD
USA
East Hanover, NJ
Research & Development
Full Time
Regular
No
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346678BR

Clinical Trial Supply Manager

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