Associate Director, Quantitative Clinical Pharmacology

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Job description

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

The Associate Director, Quantitative Clinical Pharmacology is responsible for the content and conduct of the Clinical Pharmacology studies as well as for all Clinical Pharmacology aspects of the clinical study protocols and clinical study reports. This position works collaboratively with involved functions and vendors/contract research organizations and consultants and is responsible for the timelines and budgets of the Clinical Pharmacology studies in collaboration with the Project Manager and relevant functions. May also be involved in business development activities and due diligences.

We are seeking a highly motivated individual to support our aggressive and innovative drug development pipeline. The incumbent will be supporting discovery, preclinical, and clinical drug development by providing pharmacokinetic and clinical pharmacology expertise across early and late development phases. The candidate will perform analysis of discovery pharmacology, animal toxicology, and clinical Phase I-III study data, and may represent the PK/CP department on cross-functional teams as needed. In addition, this position will support project teams with PK/PD M&S-based input to study design, evaluations, integrated data analysis, and reporting.

Responsibilities

• Lead quantitative and innovative strategies within Clinical Pharmacology to integrate MIDD during the life cycle of the program.
• Develop Clinical Pharmacology study protocols in collaboration with all functions, vendors and consultants and selection of the appropriate Clinical Pharmacology vendors, including laboratories for pharmacokinetic analyses.
• Input into Clinical Pharmacology sections of Investigator brochures, Clinical study protocols and reports, presentations, briefing documents, and submissions, in collaboration with all functions, vendors and consultants.
• Planning Clinical Pharmacology aspects for development projects, including input into the development plans and Clinical Pharmacology support for Phase 1 through 3 studies.
• Evaluate and apply state-of-the-art quantitative pharmacology approaches for clinical pharmacology decision-making and for global regulatory submissions, including INDs, IBs, NDAs, BLAs, MAAs, and pediatric plans in collaboration with key stakeholders.
• Develop high-quality modeling and simulation strategy and content: author/review/approve modeling and simulation analysis plans and outputs, interpretation, and presentation of key findings to regulators and to stakeholders as needed.
• Analysis of PK/PD data, both clinical and nonclinical, using sophisticated mathematical and statistical modeling and simulation tools to support dose selection, study design and proof-of-concept in early research, preclinical, and/or Clinical Development programs, including:
  • Translational PK/PD modeling for animal pharmacology/toxicology study design and FIH dose selection.
  • Population PK/PD modeling and exposure-response analyses supporting Phase 2/3 dosing and NDA submissions.
• Prepare and update timelines and budgets of the Clinical Pharmacology studies in collaboration with the Project Manager and respective functions to ensure prompt and accurate execution of deliverables from Clinical Pharmacology studies and programs.
• Author and review PK/PD modeling reports and PK-related sections of regulatory documents (e.g., study protocols and reports, IB, IND/IMPD, and NDA).
• Involvement in internal process improvement activities such as SOPs or guidance documents, as assigned.
• Opportunity to mentor Clinical Pharmacology fellows and interns.
• Involvement in Business development activities and due diligences.

Experience and Qualifications

• Ph.D., PharmD, or MD with training in clinical pharmacology, PKPD, Pharmacology, and Pharmaceutical Sciences.
• 7 or more years of experience in Clinical Pharmacology and drug development.
• Experience in PK/PD modeling; including preclinical to clinical translation and population analyses.
• Data manipulation, programming, and visualization skills and ideally with the use of programs such as R or similar programs.
• Hands on experience in using pharmacometrics (PMx) tools and software (e.g., WinNonlin, NONMEM, and R) for individual (e.g., noncompartmental analysis, NCA) and population PK (PopPK) analysis, modeling, and simulations (M&S).
• Familiarity of related disciplines (e.g., bioanalytics, biostatistics, toxicology, regulatory) in the drug development process.

Skills and Abilities

• Demonstrated ability to be a fast learner.
• Demonstrated ability to be flexible and adaptable to change.
• Recognized for sustained scientific excellence.
• Extensive knowledge of quantitative analyses as well as the physiological/pharmacological aspects of drugs.
• Thorough understanding of ICH Good Clinical Practices, Clinical Safety Data Management, clinical trials management (including protocol design, data management, site monitoring, statistical reporting, report writing), regulatory compliance and auditing including broad application of knowledge in different therapeutic areas.
• Leadership capabilities for cross functional teams.
• Good organizational, communication and presentation skills, including presentations to senior management and external audiences and experts.
• Excellent written and oral communication skills with incredible attention to detail.
• Ability to work on several projects and assignments at the same time and prioritize tasks.
• A commitment to collaborative leadership, management, teamwork, delegation and foster a professional culture based on trust and mutual respect.
• Up to 10% travel.

The expected base pay range for this position is $170,000 - $235,000 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.

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.

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