Contract Role - Manager, Supply Chain and Distribution - East Coast based / at Mirador Therapeutics, Inc.

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Full Time

Start Date

Immediate

Expiry Date

18 Apr, 26

Salary

150000.0

Posted On

18 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Supply Chain Management, Global Logistics, Forecasting, Clinical Trials, Regulatory Compliance, Excel, Communication Skills, Interpersonal Skills, Attention to Detail, Adaptability, GMP, Label Development, Import/Export Regulations, Clinical Supply Chain, Drug Products, Inventory Management

Industry

Biotechnology Research

Description

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 We are seeking an experienced contractor to work as 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. This role is remote - based on the E. Coast, USA 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. Experience and Qualifications 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. 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 a must. Demonstrated working knowledge of international regulations governing transport and distribution of CTM materials. Ability to travel up to 10%. Skills and Abilities 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. Experience with GMP manufacture of drug products for clinical use is a plus. Broad exposure to multiple dosage forms is a plus. $110,000 - $150,000 annualized equivalence. Actual pay will be determined by several factors such as job-related skills, experience and relevant education or training. This range may be modified in the future. #LI-remote Working at Mirador Therapeutics | Great Place To Work® All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class. Read our Job Applicant Privacy Policy

Responsibilities

The successful candidate will manage the operations and distribution of investigational drug products and clinical trial supplies. This includes overseeing global import/export logistics and ensuring continuity of supplies for assigned studies.