ImmPACT Bio

Providing medical leadership and support at an innovative cell therapy biotech with active clinical programs in oncology as well as other therapeutic areas.

Executive Medical Director

Kyverna Therapeutics

Providing medical leadership at an innovative, pre-IPO biotech, focused on advancing cell based therapy/CAR-T in autoimmune disease.

BioCryst Pharmaceuticals, Inc.

Providing medical leadership on drug development program for a growing, commercial stage biotech, focused on rare diseases.

Senior Medical Director

PRA Health Sciences

Promoted to Senior Medical Director, based on experience and performance, with ongoing responsibilities  providing medical leadership on global, late-stage clinical trials in rheumatology indications. Served as medical lead on Tulip 1, Tulip 2 and Tulip LTE studies of anifrolumab/Saphnelo, which were part of successful BLA submission of this biologic in SLE.

Providing medical leadership on global rheumatology studies, including serving as a global medical lead on late stage SLE program for a major pharmaceutical sponsor.  Expertise includes protocol and informed consent review, study design,  addressing regulatory comments/queries, data review, safety review, patient profile review and safety narrative writing, as well as working with cross-functional teams from clinical operations, regulatory, data management and biostatistics, drug safety/pharmacovigilance, medical writing, and external vendors to ensure study success from start up through database lock.

Medical Director

Sanofi

Providing medical operations leadership on clinical trials for rheumatology/inflammation pipeline for a leading global pharmaceutical sponsor, with focus on late stage studies, including pivotal phase III trials.  Cross functional expertise and experience in trial design, protocol writing, feasibility analysis, regulatory submissions, medical monitoring, data review, safety review, and preparation of study result reports.  Also, experience in pivotal studies leading to BLA/NDA and MAA submission for sarilumab(Kevzara), a fully human anti-IL-6R antibody.  RA-MONARCH study in particular, where I served as study director, completed recruitment 4 months ahead of schedule, and allowed Sanofi & Regeneron to advance MAA submission to EMA a full quarter ahead of schedule.   MONARCH study and results were also highlighted by Sanofi CEO Olivier Brandicourt as a major company milestone and accomplishment in Q1 2016 earnings report.

Director

PAREXEL

Medical monitoring of rheumatology clinical trials, including data and safety reviews.  Providing medical guidance in protocol design.  Delivering therapeutic area training to clinical teams.  Working with cross-functional teams including drug safety, data management, clinical ops, patient recruitment, regulatory, and medical teams for successful completion of clinical trials. Experience in global phase II/phase III studies in various rheumatologic disease states, including RA, SLE, and osteoarthritis.

Associate Medical Director

American College of Rheumatology

volunteer

UNT Health Science Center

Served as chief of rheumatology division, with 5 full time rheumatologists, 2 physician assistants, 2 full time clinical trial coordinators, in addition to clinic staff.  The rheumatology division covered a busy outpatient clinic practice, in addition to clinics and inpatient consults at 2 hospital systems. Also, our division supported teaching of medical students, residents, and specialty fellows. Our division was also one of the most active divisions at our medical school in clinical trials, participating in several pivotal phase 3 studies for rheumatologic therapies.

chief, rheumatology

Univeristy of North Texas Health Science Center and UNTHealth

Providing rheumatology care in a busy academic rheumatology practice, including inpatient consults. Also teaching medical students, residents, and fellows. Introduced musculoskeletal ultrasound to the clinical practice.  Served as sub-investigator or principal investigator on numerous rheumatology studies, in particular in rheumatoid arthritis.

Assistant Professor, Division of Rheumatology, Dept. of Internal Medicine

UT Southwestern Medical Center at Dallas

Fellow, Rheumatology

Resident, Internal Medicine

Experienced drug development professional: board certified rheumatologist providing medical leadership in drug development/clinical trials, spanning small molecule, biologic, as well as cell therapy/CAR-T therapeutics.  Experience in providing medical leadership in full course of a clinical trial, from initial study design through final database lock and post-study publications.  Experience in a variety of therapeutic areas, including within rheumatology (in particular rheumatoid arthritis and SLE), nephrology, hematology, oncology (lymphoma) and rare disease indications. Served as medical lead on successful pivotal, phase III studies leading to BLA approvals for 2 compounds (sarilumab/Kevzara and anifrolumab/Saphnelo). Over last few years, led successful IND clearances in novel cell therapy (CAR-T) programs in autoimmune diseases as well as successful Fast Track Designation submissions.

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