Senior Manager, Clinical Supply Planning

Iovance Biotherapeutics; Oregon; Hybrid; USD 180,000 - 195,000; Full time

Job summary

Iovance Biotherapeutics, Inc. seeks a Senior Manager of Clinical Supply Planning to design and implement the clinical supplies strategy for trials. You will oversee packaging, labeling, distribution, and returns at CMOs while maintaining budgets and on-time delivery.

Lead global forecast plans, coordinate with Clinical Operations, Regulatory, QA, and external vendors, and ensure uninterrupted supply for multiple programs and regions.

Qualifications

• Bachelor's degree required in biotech or related field.
• 9+ years of experience with a BS degree or 7+ years with a MS in clinical supply/planning roles.
• Experience with time-critical, temperature-sensitive products is preferred.
• Proficiency with Oracle/ERP and related data systems is desired.

Responsibilities

• Oversee labeling, packaging, release, distribution and returns of clinical supplies at CMOs.
• Create and manage global forecast plans and budgets for multiple programs.
• Develop global supply strategies to support clinical studies with cross-functional collaboration.

Skills

Forecasting

Budgeting

SOP writing

Analytical skills

Cross-functional

Excel

Education

BS in Biotech or related field

MS in related field

Tools

Oracle/ERP

courier systems

material ordering portals

Job description

About Iovance Biotherapeutics, Inc.Iovance Biotherapeutics , Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers. The Iovance TIL platform spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. For more information, please visitAmtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.Information on Iovance's broad, industry-leading patent portfolio is available on the Intellectual Property page onOverview

The Senior Manager, Clinical 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).

Specific Responsibilities

• Oversee the Clinical 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.

Education and Qualifications

• Bachelor's degree in a Biotech or related field.
• 9 years of experience with a BS degree, 7 years with a Masters in a related Clinical 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.

The annual base salary we reasonably expect to pay is listed. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of the role, job duties/requirements, and relevant education, experience and skills.Pay Transparency$180,000—$195,000 USD

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

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.

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