Ingrid J Chang MD MBA
About
Ingrid J Chang MD MBA is from Denver, Colorado, United States. Ingrid is currently Senior Medical Director, Sr. Clinical Development Lead - PMN at Biogen. In Ingrid's previous role as a Senior Director, Clinical Development in Inflammation (MD) - Global Development Lead at Gilead Sciences, Ingrid worked in Foster City, California, United States until Aug 2024. Prior to joining Gilead Sciences, Ingrid was a Director, Clinical Development in Inflammation (MD) at Gilead Sciences and held the position of Director, Clinical Development in Inflammation (MD). Prior to that, Ingrid was a Vice President, Western Nephrology at Western Nephrology, based in Westminster, Colorado from Jan 2020 to Mar 2020. Ingrid started working as Finance Committee, Member at Western Nephrology in Westminster, Colorado in Apr 2017. From Jan 2017 to Mar 2020, Ingrid was Medical Executive Committee at HCA Healthcare, based in North Suburban Hospital. Prior to that, Ingrid was a Chair of Medicine at HCA Healthcare, based in North Suburban Hospital from Jan 2017 to Mar 2020. Ingrid started working as Clinical Research, Principal Investigator at Western Nephrology in Jul 2007.
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Ingrid J Chang MD MBA's current jobs
* Develop, implement, and oversee the clinical development strategy of felzartamab in the treatment of autoimmune kidney diseases (Primary Membranous Nephropathy - PROMINENT study, IgA Nephropathy - PREVAIL study, Lupus Nephritis) * Conceptualizing, planning, and executing Ph3 clinical trials for felzartamab * Oversee scientific and medical studies, including serving as the senior clinical development study lead and global lead medical monitor for Ph 3 clinical trials * Lead and direct clinical trial protocol design and clinical study reporting * Provide scientific and clinical guidance to lead cross-functional teams and colleagues to meet clinical development project deliverables and timelines * Direct regulatory responses and submissions to health authorities globally * Provide input and direction on strategic development from the drug discovery stage through product registration * Directing interactions with key opinion leaders and PIs * Cross-functional collaboration for data registry analysis to assess potential new endpoints in glomerular diseases * People manager and mentor * Co-founder of the Biogen West Coast Hub chapter of the Women's Impact Network (WIN)
Ingrid J Chang MD MBA's past jobs
* Develop, implement, and oversee the clinical development strategy of tilpisertib, a novel TPL2 inhibitor, in the treatment of ulcerative colitis (Ph2 FALCON study, Ph2 PALEKONA study) * Clinical development study director and global lead medical monitor for the Ph 3 studies with the JAK inhibitor, filgotinib, in the treatment of Crohn’s disease (DIVERSITY and DIVERSITY LTE) * Conceptualizing, planning, and execution of various Ph 1 studies including FIH study, DDI/Food effect study, Japan Bridging study * Global lead medical monitor for Ph 1-3 studies * Engage in responses and submissions to regulatory health authorities, including FDA, EMA, PMDA, MHRA * Direct engagement and collaboration with KOLs/SMEs * Collaborate with cross-functional departments to develop and execute clinical trial protocols, study timelines, and budgets * Provide expert guidance and support to cross-functional teams, including clinical operations, regulatory affairs, and medical affairs * Collaborate with key stakeholders to ensure timely and successful execution of clinical trials * Identify and address potential risks and issues that may impact clinical trials * Evaluate and analyze clinical trial data to inform decision-making and identify potential areas for improvement * People manager and mentor
* Site PI for Phase II and Phase III clinical research trials involving both CKD and ESRD patients
* Full Partner, 2010-2020 * Involved in all aspects of clinical nephrology, including the care of patients with AKI, CKD, ESRD, and renal transplant in both the hospital inpatient and outpatient settings * Clinical expertise in CRRT, IHD, SLED, PD * Medical Director of in-center dialysis units (DaVita, American Renal Associates)
* Conducted basic research studies in acute kidney injury models, glomerulonephritis, and models of diabetic nephropathy * Clinical nephrology attending at Vanderbilt University Medical Center * Served on the Admissions Committee for the Vanderbilt University School of Medicine (VUSM) * Taught VUSM medical students (renal physiology, physical examination) and served as a clinical mentor/faculty advisor to medical students throughout their 4 years of medical school