Associate Director, Clinical Supply Management
About The Position
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 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.
Requirements
- Bachelor’s degree is required with 10+ years of directly related working experience OR equivalent combination of education and work experience.
- Knowledge of cGMP, 21 CFR Part 11, and Annex 13 requirements is required
- Knowledge of drug development process is required.
- Experience collaborating and working strategically with cross functional teams is required.
Nice To Haves
- Knowledge of Interactive Response Technology and Simulation Tools set-up and management is preferred.
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 application of standards across CSM to ensure cross-program consistency, quality and efficiency.
Benefits
- health, life and disability benefits
- a 401(k) with company contribution and match
- a variety of other benefits
- a generous time off package including vacation, personal days, holidays and other leaves
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What This Job Offers
Job Type
Full-time
Career Level
Manager
