Manager/Sr. Manager Clinical Trial Supply Management
The Manager, Clinical Trial Supply Management will work as an integral member of the Aimmune team, assisting in the development of investigational drug products used in Oral Immunotherapy (OIT) treatments. The successful candidate will manage the supply chain activities for investigational medicinal products (IMP) and clinical trial materials (CTM) used in Aimmune clinical and non-clinical studies.
The core responsibilities include management clinical supply chain distribution for Aimmune studies, management of vendors performing the packaging, labeling, distribution, inventory, returns, and destruction of IMP/CTM. The position closely interacts with Aimmune’s Clinical Development/Operations, Manufacturing, Quality Assurance, and Regulatory groups, and with external vendors. Prior experience with managing the supply chain for IMP/CTM to clinical sites in the US, the EU, and other regions and the demonstrated ability to work effectively in a virtual manufacturing environment are requirements for the position.
- Manage distribution activities for Aimmune clinical studies, troubleshoot depot to site shipments, set rush shipments. Interface with internal and external contacts as required.
- Manage labeling (in multiple languages), packaging, inventory, distribution, and reconciliation of IMP/CTM for multi-national clinical studies
- In conjunction with Clinical Operations and Quality Assurance, develop requirements for clinical study drug and other drug supply as required (GLP, non-GLP non-clinical), including label copy, packaged product specifications, product shipping and storage specifications.
- Work with Clinical Operations and outside vendors to design and implement the IXRS system used to automate the distribution of IMP/CTM to drug depots and clinical sites
- Maintain and ensure compliance with all applicable CTM material import / export regulations. Develop new functional SOPs, as necessary, and provide training on CTM to Aimmune staff.
- Develop and maintain applicable metrics to monitor performance relative to clinical trial inventory and planning
- Provide general CMC support to projects and products, as needed
Education and/or experience:
- Bachelor’s Degree in applicable discipline and a minimum of 3 to six years professional experience, or equivalent experience, in pharmaceutical/biotech industry and two years minimum experience with IMP/CTM supply management.
- Experience in managing complex distribution IMP/CTM supply chains for double-blinded, placebo-controlled clinical trials in multiple geographies
- Understanding of CFR and ICH guidelines, regulations and guidelines governing conduct of clinical studies a must
- Demonstrated working knowledge of international regulations governing transport and distribution of CTM materials
- Flexibility to travel on company business as required
- Excellent written and verbal communication skills
- Familiar with IMP labeling requirmentw
- Accuracy and attention to detail
- Experience with GMP manufacture of drug products for clinical use is a plus
- Broad exposure to multiple dosage forms is a plus.
- Strong interpersonal skills and ability to function in a dynamic cross-functional team environment.
- Strong computer skills, with proficiency in spreadsheet, presentation and word processing software
- Adaptability, flexibility, independence, and resourcefulness to multi-task as needed to thrive in a dynamic small company environment