Senior Manager, Supply Chain and Distribution - East Coast based / Remote

About the position Mirador Therapeutics, Inc. is a clinical-stage precision medicine company focused on developing first-and/or best-in-class next-generation therapeutics for immunology and inflammation. The company’s Mirador360™ precision development engine leverages the latest advances in human genetics and data science to rapidly deliver new precision medicines for patients living with immune-mediated inflammatory and fibrotic diseases. Mirador has raised over $650 million from leading life sciences investors and is based in San Diego, CA. Mirador was named Best Places to Work by Biospace and is a Great Place to Work-Certified™ Company.

Summary

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. The core responsibilities include management of clinical supply chain activities for Mirador studies, IRT, Global logistics to import/export Drug Substance and products, forecasting, coordinating activities with vendors performing the packaging, labeling, distribution, inventory, global distribution, returns, and destruction of IMP/CTM. The position closely interacts with Mirador’s Clinical Development/ Operations, CMC, Quality Assurance, and Regulatory groups, and with external vendors. Prior experience with managing the global supply chains for small and large molecule IMP/CTM to clinical sites and demonstrated ability to work effectively in a virtual manufacturing environment are requirements for the position.

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.

Requirements

• Bachelor’s Degree in applicable discipline.
• 8 or more years of pharmaceutical/biotech industry, with 6 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.

Nice-to-haves

• 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.

Benefits

• bonus
• equity
• comprehensive benefits

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