Mirador Therapeutics · 17 hours ago
Contract Role - Manager, Supply Chain and Distribution - East Coast based / Remote
United States
Contract
Remote
Senior Level
$110K/yr - $150K/yr
7+ years expMirador Therapeutics, Inc. is a clinical-stage precision medicine company focused on developing next-generation therapeutics for immunology and inflammation. They are seeking an experienced contractor to manage the operations and distribution of investigational drug products and clinical trial supplies, ensuring continuity of supplies and compliance with regulations.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
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, by interfacing with internal and external partners as required
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, responsible for detailed and accurate ongoing supply forecasting utilizing enrollment projections and study assumptions
In conjunction with CMC, Clinical Operations and Quality Assurance, develop requirements for clinical study drug and other drug supply as required (GMP, non-GMP non-clinical), including label development, packaged product specs, IMP manual, product shipping and storage specifications
Provide URS input, conduct UAT, manage and maintain IRT system by working with Clinical Operations and outside vendors to design and implement the IRT settings used to automate the distribution of IMP/CTM to drug depots and clinical sites
Initiate, develop or obtain shipping paperwork (Proforma invoice, USDA and End Use Letters, Import license applications etc), 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 for all shipments
Provide input to or write functional SOPs, as necessary, and provide training on CTM to Mirador staff and CRO’s as required
Qualification
Required
Bachelor's Degree in applicable discipline
7 or more years of pharmaceutical/biotech industry, with 5 years or more experience in IMP/CTM supply management
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 a must
Demonstrated working knowledge of international regulations governing transport and distribution of CTM materials
Ability to travel up to 10%
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 in nature 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 a must
Preferred
CSCP, CPIM, CLTD certifications are a plus
Experience with GMP manufacture of drug products for clinical use is a plus
Broad exposure to multiple dosage forms is a plus
Company
Mirador Therapeutics
Mirador Therapeutics develops precision medicines for immune-mediated diseases.
11-50 employees
Funding
Current Stage
Growth StageTotal Funding
$730MKey Investors
ARCH Venture Partners
2026-01-12Series B· $250M
2024-04-03Series Unknown· $80M
2024-03-21Series A· $400M
Recent News
2026-01-16
Company data provided by crunchbase