What are the responsibilities and job description for the Director, Supply Chain position at Mirador Therapeutics, Inc.?

Mirador is a next-generation precision medicine company focused on immunology and inflammation. The company’s Mirador360

precision development engine leverages the latest advances in human genetics and cutting-edge data science to rapidly advance new precision medicines for patients living with chronic immune-mediated inflammatory and fibrotic diseases. Launched in 2024, Mirador has raised over $400 million from leading life sciences investors and is based in San Diego, CA.

Summary

Mirador is seeking a highly motivated hands-on Director, Supply Chain individual contributor responsible for technical leadership and operational management of formulation, drug product and supply chain activities in support of pre-clinical and clinical stage development programs.

Responsibilities

Apply scientific expertise to design and implement innovative solutions for development of therapeutic proteins to address key challenges and support project deliverables according to timelines.
Independently designs, oversees, interprets and presents results from studies to proactively make recommendations for decision making and influence the direction of drug product development strategies and activities.
Establish supply chain strategies and risk mitigation plans to ensure continuous supplies for clinical studies for pipeline programs at different development phases.
Responsible to manage CMO and depot supply chain operations including protocol interpretation, forecasting demand planning, supply planning, distribution, inventory management, label generation and approval, and packaging and labeling.
Partner with internal and external stakeholders to develop and implement drug product and supply chain plans in support of broader project team and organizational goals.
Collaborates with Clinical Operations, CMC, Quality, Regulatory, and Project Management partners to develop optimal supply strategies and ensure on-time delivery of clinical supplies to initiate and resupply studies with investigational medicinal product (IMP).
Provide expertise in US and ex-US regulatory requirements for packaging, QP release of material, label text requirements and distribution logistics.
Assist in developing multi-year rolling forecast for the portfolio; collaborate across departments to ensure adequate availability and timing of clinical supplies in support of project and corporate goals.
Drive development of interactive response systems (IXRS / IRT); coordinate system builds with Clinical Development, Biostatistics, Clinical Operations and Quality, create standard system specifications and perform User Acceptance Testing (UAT).
Coordinates and manages import, export, distribution and QP release of Investigational products to depots and sites for clinical studies, ensuring compliance with Good Manufacturing Practices (GMP) and regional regulatory requirements.
Manage relationships with CDMOs, CROs and key suppliers including coordination, communication and technical oversight, to meet accelerated timelines and ensure timely delivery of cGMP supplies to support clinical trials.
Serve as primary point of contact to the CMOs to provide technical oversight for drug product process development, formulation development, analytical method development and qualification, batch manufacture and testing, clinical packaging and labeling, supply chain management, stability studies, deviation investigation, batch review and release of cGMP material.
Generate high quality data based on sound scientific principles and prepare data summaries, technical reports, scientific presentations and regulatory documents.
Collaborate with internal and external stakeholders to support project plans and schedules, ensuring that tasks are executed in accordance with operational plans, cGMP requirements and regulatory commitments.

Experience and Qualifications

Degree in a scientific discipline (e.g., Chemical Engineering, Biochemistry, or related field); PhD with 5 or more years experience in a development environment, Master’s degree with 8 or more years experience in early-stage clinical development, or Bachelor’s degree with a 10 or more years experience

Highly experienced in the following areas : drug product, formulation development, analytical method development and qualification and supply chain management

Technical expertise in early-stage clinical development and cGMP manufacture of recombinant mammalian produced biologic products

Clinical supplies experience / knowledge in forecasting, demand / supply planning, IRT systems, inventory management, clinical labeling and distribution including cold chain, import / export and reverse logistics

Experience with budgeting and managing contract organizations for clinical labeling, packaging and distribution, including cold chain

Strong knowledge of the FDA, cGMP, and GCP standards as well as regulatory guidance documents such as Annex 13

In-depth understanding of CMC, GMPs, quality, clinical operations and blinding practices, and IRT / IWRS systems

Working knowledge of import and export requirements in a regulated environment

Skills and Abilities

Must have demonstrated experience in managing and influencing diverse project activities with third party manufacturing facilities at different geographical locations

Strong project management experience with cross functional team leadership and participation skills

Strong collaboration, influencing and negotiation skills; ability to work effectively with internal cross-functional groups and external suppliers to meet the aggressive clinical study timeline and patient needs

Demonstrated ability to effectively manage CDMOs globally

Excellent communication skills (interpersonal, written and verbal)

Must be well organized, proactive and detail-oriented

Ability to multi-task and work efficiently in an environment with changing priorities

Experience in a fast-paced environment

Willingness to travel, depending on business needs

The expected base pay range for this position is $185,000 - $225,000 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.

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Salary : $185,000 - $225,000

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