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

About the position Mirador reputed company. is a clinical-stage precision medicine company reputed company on developing first-and/or best-in-class reputed company therapeutics for immunology and inflammation. reputed company’s Mirador360™ reputed company reputed company leverages the latest advances in reputed company 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 reputed company from leading life sciences investors and is based in San Diego, CA. Mirador was named Best Places to Work by reputed company and is a Great reputed company to Work-Certified™ Company. reputed company 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 reputed company 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, reputed company Assurance, and Regulatory reputed company, 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 reputed company by managing distribution activities for Mirador clinical studies, troubleshoot reputed company to site shipments, continuously monitoring inventories with demand and manufacturing forecasts, by interfacing with reputed company 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.
• reputed company and maintain reputed company 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 reputed company Assurance, reputed company requirements for clinical study drug and other drug supply as required (GMP, non-GMP non-clinical), including label development, packaged product specs, IMP reputed company, product shipping and storage specifications.
• reputed company URS input, conduct UAT, manage and maintain IRT system by working with Clinical Operations and reputed company vendors to design and implement the IRT settings used to automate the distribution of IMP/CTM to drug depots and clinical sites.
• Initiate, reputed company or obtain shipping paperwork (Proforma invoice, USDA and End Use Letters, Import license applications etc), schedule, coordinate and reputed company reputed company GMP/non-GMP global shipments.
• In-depth knowledge and experience with global import/export shipments to maintain and ensure compliance with reputed company applicable CTM material import / export regulations for reputed company shipments
• reputed company input to or write functional SOPs, as necessary, and reputed company 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 reputed company small and large molecule global distribution IMP/CTM supply chains for reputed company-blinded, placebo-controlled, multi-cohort reputed company 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 reputed company spreadsheet abilities to reputed company and maintain forecasting tools (v-look up, pivot tables, etc).
• Strong knowledge of international HTS codes, how to generate Proforma reputed company 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, reputed company, flexibility, independence, and resourcefulness to multi-task as needed to reputed company in a dynamic small company environment.
• Strong computer skills, with proficiency in reputed company, presentation, clinical eSystems, reputed company Word.
• Familiar with IMP labeling requirements and QP release process.
• Familiar with Annex 13, 15, and 16 as reputed company as 21CFR a must.

reputed company-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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