Associate Director / Director of Clinical Data Management
Halia Therapeutics, Inc., Lehi, Utah, United States, 84043
Halia Therapeutics is a clinical‑stage biopharmaceutical company focused on developing novel therapies to improve the lives of patients with inflammatory disorders and neurological diseases. The company advances innovative medicines that modulate the immune system's response to resolve chronic inflammation and reduce damage caused by aberrantly activated immune pathways.
Overview
Position Overview Halia Therapeutics is seeking an experienced Associate Director or Director of Clinical Data Management (CDM) to lead the data strategy, execution, and quality oversight of clinical data across its expanding development pipeline. This role ensures high‑quality, inspection‑ready clinical trial data to support regulatory submissions and scientific decision‑making. Responsibilities
Lead the clinical data management function across all clinical programs, ensuring compliance with GCP, regulatory requirements, and industry standards. Develop and implement CDM strategies, processes, and infrastructure to support therapeutic areas in inflammation and neurology. Oversee end‑to‑end data lifecycle including CRF design, database build, data cleaning, coding, reconciliation, and database locks. Ensure timely, high‑quality data delivery for decision points, regulatory filings, and publications. Lead vendor selection and oversight for EDC, IRT, ePRO, central labs, and other data‑generating systems. Establish and maintain SOPs, standards, and quality frameworks to ensure inspection readiness. Build and mentor a high‑performing CDM team. Qualifications
Bachelor’s degree in life sciences, mathematics, public health, or related field; advanced degree preferred. 8+ years of clinical data management experience in biotech/pharma, with leadership responsibilities. Familiarity with data review, visualization, or reporting tools (e.g., SAS, R, or similar) is a plus. Experience in immunology, neurology, oncology or inflammation‑related clinical programs. Strong familiarity with FDA, EMA, and ICH‑GCP requirements. Expertise with EDC platforms and CDM tools; experience with biomarker or lab‑intensive datasets is a plus. Excellent communication, leadership, and problem‑solving skills. What Halia Therapeutics Offers
Opportunity to contribute to innovative therapies in inflammation and neurological disease. Competitive compensation, equity, and comprehensive benefits. This is an onsite position in our Lehi Utah office and relocation assistance is not available.
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Position Overview Halia Therapeutics is seeking an experienced Associate Director or Director of Clinical Data Management (CDM) to lead the data strategy, execution, and quality oversight of clinical data across its expanding development pipeline. This role ensures high‑quality, inspection‑ready clinical trial data to support regulatory submissions and scientific decision‑making. Responsibilities
Lead the clinical data management function across all clinical programs, ensuring compliance with GCP, regulatory requirements, and industry standards. Develop and implement CDM strategies, processes, and infrastructure to support therapeutic areas in inflammation and neurology. Oversee end‑to‑end data lifecycle including CRF design, database build, data cleaning, coding, reconciliation, and database locks. Ensure timely, high‑quality data delivery for decision points, regulatory filings, and publications. Lead vendor selection and oversight for EDC, IRT, ePRO, central labs, and other data‑generating systems. Establish and maintain SOPs, standards, and quality frameworks to ensure inspection readiness. Build and mentor a high‑performing CDM team. Qualifications
Bachelor’s degree in life sciences, mathematics, public health, or related field; advanced degree preferred. 8+ years of clinical data management experience in biotech/pharma, with leadership responsibilities. Familiarity with data review, visualization, or reporting tools (e.g., SAS, R, or similar) is a plus. Experience in immunology, neurology, oncology or inflammation‑related clinical programs. Strong familiarity with FDA, EMA, and ICH‑GCP requirements. Expertise with EDC platforms and CDM tools; experience with biomarker or lab‑intensive datasets is a plus. Excellent communication, leadership, and problem‑solving skills. What Halia Therapeutics Offers
Opportunity to contribute to innovative therapies in inflammation and neurological disease. Competitive compensation, equity, and comprehensive benefits. This is an onsite position in our Lehi Utah office and relocation assistance is not available.
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