Stacey Ruiz
Senior Vice President @ CalciMedica
About
Accomplished cross-functional executive with expertise in drug development and pipeline strategy in various therapeutic areas including cardiorenal, immunology, and oncology; skilled in building and leading clinical and pre-clinical development programs, creating novel approaches to address clinical and pre-clinical findings, and communicating complex scientific concepts in a clear, concise manner; demonstrated ability in creating stakeholder value by negotiating licensing activities and creating opportunities for global partnering; strong leader, effective at creating efficient workflows and decisive decision-making in fast-paced environments
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United States
Biotechnology
Product Development / Pipeline Strategy, Drug Development, Biotechnology, Clinical Development, Translational Medicine, Cross-functional Team Leadership, Clinical Research, Nephrology, Lifesciences, Oncology, Medical Affairs, Clinical Trials, Clinical Data Management, IND, Pharmaceutical Industry, CTMS, Regulatory Submissions, Drug Discovery, Biopharmaceuticals, GCP
Experience
Senior Vice President
CalciMedica
Responsible for strategic leadership and management of development programs; provide clinical development oversight for clinical study design, statistics and data analytics, and clinical regulatory filings; support and facilitate decision-making on business development efforts
Consultant, Biotech Development
Independent Consultant
Greater Los Angeles Area
Support clinical and pre-clinical programs, medical affairs and commercial activities, regulatory submissions, and business development
Vice President, Clinical Development
Renibus Therapeutics Inc
Provided strategic planning and led development of product portfolio; designed and executed clinical studies; managed clinical regulatory strategy; oversaw data analytics; developed product messaging
Vice President, Drug Development
Renibus Therapeutics Inc
Vice President, Drug Development & Medical Affairs
Renibus Therapeutics Inc
Vice President, Drug Development & Discovery
Abcentra
Developed and guided strategy for clinical and pre-clinical development; provided scientific leadership and direction over internal and partnered drug discovery programs (peptide vaccines and monoclonal antibodies)
Senior Director, Drug Development & Discovery
Abcentra
Director, Business Development and Research and Development
La Jolla Pharmaceutical Company
Greater San Diego Area
Developed two therapeutic programs; determined strategy for clinical and pre-clinical development; responsible for regulatory process, including successful IND compilation and filing, and managed clinical operations; led business development efforts, including licensing and partnering
Associate Director, Medical Affairs/Medical Communications
Reata Pharmaceuticals, Inc.
Provided strategic direction and scientific expertise to Medical Affairs, Commercial, Program Management, global partners, and KOLs to fill in knowledge gaps, ensure accurate communication of scientific concepts, and manage publication strategy and content
Associate Director, Product Development
Reata Pharmaceuticals, Inc.
Responsible for pre-clinical development of lead molecule and product portfolio; developed pre-clinical IND and NDA strategy; collaborated with partners to ensure global regulatory filings and pre-clinical development requirements were met; provided MOA and disease pathogenesis expertise cross-functionally; spearheaded and developed academic collaboration team.
Senior Manager, Translational Research
Reata Pharmaceuticals, Inc.
Demonstrated efficiency in managing, outsourcing, and reducing cost of IND/NDA-enabling pre-clinical (pharmacology and toxicology) studies; designated company writer for clear, accurate interpretation and communication of clinical and pre-clinical data for critical regulatory filings, Investigator’s Brochures, and white papers; achieved first carcinogenicity waiver for a small molecule; significant experience in pre-clinical and clinical data analyses
Manager, Translational Research
Reata Pharmaceuticals, Inc.
Identified and designed models for pre-clinical pharmacologic testing of pipeline compounds; analyzed clinical data to evaluate efficacy and safety of lead molecule and determine the appropriate dosing regimen for further development; provided translational scientific expertise for Clinical Development
Post-doctoral Fellow
Dana-Farber Cancer Institute/Harvard Medical School
Boston, MA
Education
University of Notre Dame
Science Preprofessional Studies
Stacey Ruiz's Contact Information
Phone
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