[Hiring] Senior Manager, Supply Planning @Iovance Biotherapeutics

Role Description

The Senior Manager, Supply Planning designs, develops, and implements the clinical supplies strategy for clinical trials. This individual also manages activities including planning and forecasting of clinical supply, oversight of clinical packaging, labeling, and distribution operations at contracted manufacturing organizations (CMOs).

• Oversee the labeling, packaging, release, distribution and returns of clinical supplies at external CMOs for the assigned studies, maintaining budget and ensuring that the projects are delivered on time.
• Create and manage clinical forecast plans and budgets for clinical supplies for multiple programs and study levels, based on clinical study protocol and clinical operations plans.
• Create global supply strategies, supply plans to support clinical studies; collaborate with Clinical Operations, Regulatory Affairs, Quality Assurance, and external vendors to execute the strategies for the clinical studies.
• Support Clinical Operations with new site onboarding and the management, forecasting, and distribution of co-therapy drugs in the US and ex-US for all clinical programs.
• Manage clinical trial supply to ensure timely IMP production; manage inventory and worldwide distribution activities; ensure uninterrupted supply.
• Manage label development process from generation of the master label text to label printing.
• Implement scheduling software program for all clinical trials and future commercial requirements from collection to infusion incorporating chain of custody and identification, real time scheduling and tracking.
• Manage the development, review, and User Acceptance Testing (UAT) of the Interactive Response Technology (IRT) system.
• Review manuals and other documents with Clinical Operation team.
• Represent Supply Planning function at clinical trial team meetings; communicate plans and timelines to internal and external customers and partners.
• Partner with other functional leaders in CMC, Regulatory Affairs, Clinical Operations and Quality Assurance in support of the study project teams and ensures timely supply for clinical trials.
• Deliver presentations and make recommendations to Senior Tech Ops, Clinical, and Commercial leadership.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in a related field.
• 5+ years in a related supply chain/planning/operations role.
• Prefer prior experience planning in time critical and temperature sensitive products.
• Ability to work with multiple database and electronic systems. Experience with Oracle/ERP, courier, and material ordering portals, a plus.
• Must display strong analytical and problem-solving skills. Attention to detail required.
• Outstanding organizational skills with the ability to multi-task and prioritize.
• Excellent interpersonal, verbal, and written communication skills including presentations and ability to influence all levels of staff, including executives.
• Experience in writing SOPs.
• Advanced qualitative and quantitative analytical skills to evaluate and interpret complex problems using multiple sources of information.
• Good business acumen, ability to think strategically and analytically, including financial analysis.
• Ability to balance multiple priorities in a fast-paced environment while delivering a timely and high-quality end work product.
• Skilled with Microsoft Excel and PowerPoint.

Physical Requirements

• Sit for extended periods of time in front of computer.

Pay Transparency

$180,000 — $195,000 USD

Equal Opportunity Statement

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.