Director, Clinical Science

Mirador is a next-generation precision medicine company focused on immunology and inflammation. The company’s Mirador360 _^TM 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, Clinical Science who will help with the execution of the company’s clinical studies in immune-mediated diseases. This position reports to the SVP, Clinical Development and will be responsible for the implementation, planning, and execution of clinical trial activities, that include regular data review and data cleaning activities, responses to site questions, review and support of study related documents, such as informed consent forms, protocol amendments, study newsletters, etc. This position will also contribute to the oversight of advancing the Company’s clinical studies and will serve as one of the medical liaisons between investigators and the internal study team.

 

Responsibilities

• Responsible for implementation, planning, and execution of assigned clinical trial activities, which include data review, data analysis, and reporting that conforms to the highest ethical, safety, and quality standards, and in compliance with GCP and regulatory standards
• Lead clinical trials activities, including the planning and execution of trial(s) with minimal to moderate levels of supervision
• Maintain a thorough understanding of assigned protocol and protocol requirements
• Plan and lead the implementation of clinical study start-up, conduct, close-out activities as applicable
• Serve as primary contact for site-facing activities such as training and support for clinical questions CRF design, clinical data review, query resolution; and ensure consistent, quality data review
• Identify clinical data trends; provide trends and escalate questions to study director, physician
• Develop clinical narrative plan and review clinical narratives
• Provide information required by the protocol manager for development of trial budget, CRO scope of work, etc.
• Review and develop site and CRA training materials and presentations for SIV and investigator meetings and provide support on study committee, such as safety review, meetings, activities
• Author, review clinical study reports (CSRs) and clinical portions of regulatory documents, such as pre-IND, IND, IB, DSUR, regulatory responses, and support clinical development planning and activities, such as preparation of Protocols, Protocol Amendments, Annual Reports and other safety reports

 

Experience and Qualifications

• Degree in a scientific discipline such as MD, PharmD, PhD, MS, RN or similar scientific field preferred
• 7 or more years of experience in clinical research or clinical science within a pharmaceutical or biotech environment preferred; some experience in a contract research organization (CRO), or academic institution may be considered
• Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations with skills to support data listing review, trend identification, data interpretation
• Familiarity with Medidata, RAVE, J-review or other clinical databases or other data review tools (patient profiles, listings) is desirable
• Knowledge of the data monitoring committees, dose review teams, and independent response adjudication committees
• Immunology experience preferred

 

Skills and Abilities

• Strong written and verbal communication skills, attention to detail, problem solving skills and flexible working hours
• A hands-on, entrepreneurial style with a sense of urgency, a bias toward action, comfort with calculated risk, and the ability to analyze situations rapidly and make prudent decisions
• Engaged, independent and goal-oriented; willingness to work in a highly dynamic work environment and embrace uncertainty
• Ability to multi-task and willingness to flexibly contribute simultaneously in multiple facets of drug development; willingness to learn new therapeutic areas
• Sound strategic, clinical, technical, operational, and ethical judgment with uncompromising integrity
• Willingness to travel, depending on business needs

 

The expected base pay range for this position is $200,000 - $265,000 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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