Senior Planner, Clinical Supply Chain

With oversight and guidance from the Senior Manager, Supply Planning, this role is responsible for ensuring continuous product supply in support of clinical trials. The individual will work with internal and external customers in order to accomplish clinical project objectives. The individual will develop packaging and supply plans and manage clinical supplies documentation requirements to support regulatory submissions. Responsible for monitoring inventory levels and executing resupply campaigns to ensure adequate supplies across regional depots. In addition, the individual will support supply chain initiatives and improvement activities.

Specific Responsibilities

• Partner with Clinical Operations, Clinical Science and CRO to ascertain study start timelines and clinical demand forecast to inform supply planning and inventory management decisions.
• Create, review, and update the clinical supply plans based on strategic elements/study forecast from Clinical Operation and /or Medical Affairs
• Manage sourcing and clinical labeling campaigns of commercially sourced co-therapy drugs in support of global clinical trials.
• Work cross-functionally with Quality Assurance, Regulatory Affairs, Clinical Operations, Medical Affairs, Logistics, and MSAT to ensure uninterrupted and compliant supply of study drug for clinical studies and programs.
• Manage the development and maintenance of Interactive Response Technology (IRT) and other systems used in managing inventory for clinical studies.
• Coordinate labeling, transportation, storage and distribution of clinical trial material for studies to be conducted globally where needed.
• Manage initiation and approval of label text and label proofs while developing a labeling strategy that is consistent with regulatory and study requirements.
• Review and update SOPs.
• Identify opportunities and implementation team for the continuous improvement of the Clinical Supply Chain processes.
• Work directly with all US and EU suppliers to ensure compliance of local and international GMP/regulation requirements and perform risk assessment to determine criticality.

Education and Qualifications

• Bachelor’s degree in Life Sciences, Logistics/Supply Chain or related business administration is required.
• 3 + years of relevant Clinical Supply Chain and/or Clinical Labeling experience.
• Strong knowledge and understanding of Pharmaceutical Supply Chain. Good Manufacturing/Distribution practice. Global clinical trials experience preferred.
• Self-motivated and willing to accept temporary responsibilities outside of initial job description.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Must be comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Experience with IRT and/or ERP systems is a plus.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

Work Environment

This job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible.  Requires operating standard office equipment and keyboards.

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. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.

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