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.
This position is a hybrid role with expectations to be onsite at our East Hanover campus 3 days a week.
GCS (Global Clinical Supplies) 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. He/She/They will have operational end to end responsibility for assigned activity and will lead and manage 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 (CTT); defines and advises the CTT on the optimal clinical trial supply strategy in terms of, but not limited to, pack-aging design, technical and timeline feasibility, efficiency and risk management.
• Reviews overall clinical trial protocol/, provides inputs to develop optimal packaging design, clinical trial supply design and visit schedule.
• Creates and maintains complete and accurate clinical supply demand planning for assigned study in alignment with protocol requirements, key study parameters and milestones, patient projections, with appropriate safety stock 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 IRT set up and initiates subsequent updates throughout 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 timelines (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, appropriate lead-time and replenishment quantities to ensure compliance and continuity of clinical supplies, including proactive expiry management of clinical supplies.
• Is responsible to consolidate, maintain and track the clinical trial budget with key stakeholders for overall GCS external cost (e.g. labels, packaging, distribution and comparators).
• Actively contributes to the GCS sub team as a full member. Ensures adequate, proactive exchange of relevant knowledge & information between the GCS sub team and the CTT.
• Fully supports, prepares the GCSPL to adequately address GCS-considerations at various cross-functional teams e.g. TRD sub team, CTT, etc.What you’ll bring to the role:
• Bachelor’s degree in science, engineering, supply chain or equivalent.
• 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.
The pay range for this position at commencement of employment is expected to be between $102,400 and $153,600/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Why Novartis?
236 million lives were touched by Novartis medicines in 2022, 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.
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