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Role Description

This position will be an integral member of the Mirador CMC team, managing the operations and distribution of investigational drug products and clinical trial supplies. Global import/export logistics for Toxicology, API, Drug Products and Clinical materials is a key responsibility of this role. The successful candidate will manage the supply chain and global distribution activities for investigational medicinal products (IMP) and clinical trial materials (CTM) used in Mirador clinical and non-clinical studies.

• Ensure continuity of supplies for assigned studies and projects by managing distribution activities for Mirador clinical studies.
• Troubleshoot depot to site shipments, continuously monitoring inventories with demand and manufacturing forecasts.
• Manage labeling activities (in multiple languages, and over labeling), packaging, inventory, distribution, and final reconciliation of IMP/CTM for multi-national global clinical studies.
• Develop and maintain complex forecasting spreadsheets for clinical trial planning.
• In conjunction with CMC, Clinical Operations and Quality Assurance, develop requirements for clinical study drug and other drug supply as required.
• Provide URS input, conduct UAT, manage and maintain IRT system.
• Initiate, develop or obtain shipping paperwork, schedule, coordinate and track all GMP/non-GMP global shipments.
• In-depth knowledge and experience with global import/export shipments to maintain and ensure compliance with all applicable CTM material import/export regulations.
• Provide input to or write functional SOPs, as necessary, and provide training on CTM to Mirador staff and CRO’s as required.

Qualifications

• Bachelor’s Degree in applicable discipline.
• 8 or more years of pharmaceutical/biotech industry experience, with 6 years or more experience in IMP/CTM supply management.
• CSCP, CPIM, CLTD certifications are a plus.
• In-depth experience in managing complex small and large molecule global distribution IMP/CTM supply chains for double-blinded, placebo-controlled, multi-cohort complex clinical trials in multiple geographies.
• Solid understanding of ICH guidelines, global label development regulations and guidelines governing conduct of clinical studies.
• Demonstrated working knowledge of international regulations governing transport and distribution of CTM materials.
• Ability to travel up to 10%.

Requirements

• Must have high level of Excel spreadsheet abilities to develop and maintain forecasting tools (v-look up, pivot tables, etc).
• Strong knowledge of international HTS codes, how to generate Proforma Commercial Invoices, and initiate global shipments for both synthetic and biological materials.
• Excellent written and verbal communication skills.
• Strong interpersonal skills and ability to function in a dynamic cross-functional team environment.
• Accuracy and attention to detail is a must.
• Adaptability, agility, flexibility, independence, and resourcefulness to multi-task as needed to thrive in a dynamic small company environment.
• Strong computer skills, with proficiency in Adobe, presentation, clinical eSystems, Microsoft Word.
• Familiar with IMP labeling requirements and QP release process.
• Familiar with Annex 13, 15, and 16 as well as 21CFR.
• Experience with GMP manufacture of drug products for clinical use is a plus.
• Broad exposure to multiple dosage forms is a plus.

Benefits

• The expected base pay range for this position is $140,000 - $175,000 plus bonus, equity, and comprehensive benefits.
• The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training.
• This range may be modified in the future.