Associate Director, Clinical Supply Management

Novartis AG; Fort Worth (TX); Presencial; USD 137 000 - 257 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health, life and disability benefits

401(k) with company match

Paid time off

Resumo da oferta

Novartis AG is seeking an Associate Director, Clinical Supply Management, to lead the US CSM team in developing drug supply strategy for Sponsored, IITs, and Managed Access trials. The role oversees end-to-end supply, ensuring regulatory compliance and minimizing risk across programs.

The position will be based at East Hanover or Fort Worth, with up to 15% travel and no remote work. Local candidates only, no relocation, and a comprehensive benefits package is offered.

Qualificações

• Bachelor’s degree required with 10+ years related experience.
• Knowledge of cGMP, 21 CFR Part 11, and Annex 13 requirements.
• Knowledge of drug development process.
• Experience collaborating with crossfunctional teams.

Responsabilidades

• Oversees end-to-end supply strategy from forecast to site execution and packaging/distribution.
• Advocates early supply and financial forecast to support long-term planning.
• Collaborates with cross-functional partners to execute supply chain plans and resolve obstacles.
• Assesses risks and defines strategies to ensure supply continuity and cost control.
• Leads cost assessment of labeling, packaging, distribution and comparator activities; coordinates with Finance and Contracts.
• Sets up IRT and simulation tools for study packaging/distribution strategies.

Conhecimentos

Cross-functional collaboration

Regulatory awareness

Clinical supply management

Forecasting & planning

Formação académica

Bachelor's degree in related field

Ferramentas

Interactive Response Technology & Simulation Tools

Descrição da oferta de emprego

Job Description Summary

As the Associate Director, Clinical Supply Management, you will lead, represent, manage, and support US Medical Affairs CSM team by developing drug supply strategy and tactical approach for Sponsored, Investigator Initiated (IITs), Managed Access and Research Collaboration trials. Ensures complete project oversight and retains accountability for project deliverables. Leads operational end-to-end responsibility for assigned programs by managing supply strategy, working with cross-functional teams and minimizing supply chain risks to avoid any potential for supply disruption.

This position will be located at the East Hanover or Fort Worth site and will not have the ability to be located remotely. This position will require up to 15% travel as defined by the business (domestic and/ or international). Please note that this role would not provide relocation, and only local candidates will be considered.

Job Description

Key Responsibilities

• Oversees the entire end-to-end supply strategy (from high-level forecast to clinical sites) and reviews the planning assumption adopted in the supply plans and forecasts. Participate in the decision-making process in CSM to select the most appropriate supply model (packaging/distribution). Ensures alignment with all required regulations and guidelines in order to ensure regulatory coverage for FPFV readiness. Manages Investigational Medicinal Product (IMP) supply for clinical trials and overall bulk product inventory, maintaining quality and compliance through all activities.
• Advocates early supply and financial forecast and translating them into a demand forecast to support long-term supply and capacity planning. Delivers insights and guidance from clinical supply perspective in protocol design and clinical meetings by presenting packaging design options, defining pros/cons and influencing recommendations for path forward.
• Works with cross functional business partners to oversee the effective execution of supply chain plans while proactively identifying potential obstacles to success and taking action to resolve issues.
• Accountable for complex problem solving and resolution of issues to ensure patient supply without compromising quality, cost or delivery. Assesses risks and opportunities and defines strategies to ensure supply continuity and increase supply flexibility.
• Leads the cost assessment of labeling, packaging, distribution and comparator activities and assures CSM team works in agreement to the operation/supply model. Collaborate with Financial and Contracts team to evaluate operations spend, approve third party contracts and ensuring cost controls.
• Leads in the set-up of Interactive Response Technology (IRT) & Simulation Tool systems by incorporating the supply packaging and distribution strategies for studies (as applicable).
• Leverages AI-enabled insights and automation to optimize end-to-end clinical supply planning, execution and drug distribution through systems and processes by improving forecasting, inventory strategy, warehousing, depot-to-site distribution, risk detection, and cross-functional decision‑making—while championing responsible AI adoption, governance, and continuous team upskilling.
• CSM SME in the onboarding of new vendors partnering with QA Vendor Management and GMP Audit Team. Supports GxP audits as needed.
• Leads externalization activities and manages relationships and establishes strong partnerships with CROs, vendors, and other external partners including IRT, suppliers, distributors, and depots.
• Establishes working practices and SOPs as needed, to support industry best practices while also Identifying areas for process improvement and applicationofstandardacrossCSM toensurecross-program consistency,qualityandefficiency.

Essential Requirements

• Bachelor’s degree is requiredwith10+yearsofdirectlyrelatedworkingexperienceORequivalentcombinationofeducationandworkexperience.
• KnowledgeofcGMP,21CFRPart11,andAnnex13requirementsisrequired
• Knowledgeofdrugdevelopmentprocessisrequired.
• Experiencecollaboratingandworkingstrategicallywithcrossfunctionalteamsisrequired.

Preferred Requirements

• KnowledgeofInteractiveResponseTechnologyandSimulationToolsset-upandmanagementispreferred.

Novartis Compensation Summary

The salaryforthispositionisexpectedtorangebetween $136,600and$257,400peryear.

Thefinalsalaryofferedisdeterminedbasedonfactorslike,butnotlimitedto,relevantskillsandexperience,anduponjoiningNovartiswillbereviewedperiodically.Novartismaychangethepublishedsalaryrangebasedoncompanyandmarketfactors.

Yourcompensationwillincludeaperformance‑basedcashincentiveand,dependingontheleveloftherole,eligibilitytobeconsideredforannualequityawards.

US‑basedeligibleemployeeswillreceiveacomprehensivebenefitspackagethatincludeshealth,lifeanddisability benefits,a401(k)withcompanycontributionandmatch,andavarietyofotherbenefits.Inaddition,employeesareeligibleforageneroustimeoffpackageincludingvacation,personaldays,holidaysandotherleaves.

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

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 to perform the essential functions of a position, please send an e‑mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$138,600.00 - $257,400.00

Skills Desired

• Continual Improvement Process
• Master Data
• Materials Management
• People Management
• Production Planning
• Technical Requirements
• Waterfall Model