Expert in Pharma-BioTech Clinical Trial Development and Drug Safety, Medical Monitor
Expert is seasoned, highly versatile in clinical research, medical affairs and drug safety. She is a board certified MD and is currently active with a US medical license. She also has over 17 years industry experience. She has clinical and safety expertise in dermatology, hematology, ophthalmology, rheumatology, infectious disease, neurology, pulmonology, oncology and cardiology. She has experience in the senior level management and all Phases of clinical development I-IV clinical trial oversight, with leadership over medical affairs, clinical development, and clinical research and operations. She is familiar with pharmacovigilance, drug safety and business development review. She is able to work in fast-paced environments and conditions, is strategic, and a great team player and team builder.
She currently practices as an on-call rural Emergency Room Physician in the state of MN and has been for the past 5 years. However, her experience as a medical physician extends back to 1988, almost 21 years. Her experiences include being a physician in various divisions including blood bank, occupational medicine, urgent care and emergency room care at six different hospitals.
Expert was a shareholder of a private family medicine clinic. She divided her time by committing to extensive sub-specialty clinical trials in multiple therapeutic areas as a principal investigator. She has in-depth experience with pain, asthma, infectious disease, cardiology and pulmonology trials. Overall, she served as a principal investigator or sub-investigator for over 40 trials in over 8 medical indications. Her other duties included clinical practice in all aspects of Family Medicine (including OB) and urgent care, treating close to 100 patients per day. She also participated actively in supervising a 24-physician group and organized weekly practice management and Quality Assurance meetings for the clinic.
Her leadership experiences also include serving as a director of a physician service group for two years. She was a physician liaison, working closely with a medical staff and the CEO to plan and organize meetings and events as well as to develop new policies. She was also a physician liaison to the administration for new physicians and MD group. She was also a monthly guest presenter for the Board and a liaison assistance and troubleshooter for the medical staff for a local hospital. Other administrative duties included developing a five-year plan for the clinic, analyzing the development of the medical staff based on the five-year plan. She performed community assessment analysis based on physicians’ needs, recruiting and developed a succession plan for physicians. She also oversaw the startup loans and contracts of the private practice. She also handled budget planning, submission, and review for her department.
Expert has experience working as a medical and research director at an ophthalmology clinical research center in California for five years. Her duties included coordinating protocols and data management for multi-center clinical trials in several therapeutic areas including ocular allergic conditions, ocular hypertension, glaucoma, macular disease and ocular infections. She also supervised and consulted on drug safety and AE/SAE management.
Expert served as a Medical Monitor for novel compounds in the treatment of Oncology clinical development including development of the protocol, CRFs and drug safety plan. She evaluated and analyzed the pharmaceutical aspect of various drugs used in oncology, including the inhibitors and suppression characteristics. She performed Drug Safety reviews and summaries. She provided narratives for FDA approval of various new drugs. She also reported on EMEA events. Additionally, she oversaw the clinical trial line listing data review and data base development with clinical trial oversight for enrollment, waivers, deviations and AE/SAE management.
Expert currently works for a global drug safety company providing drug safety in the areas of DMARDS, psoriasis, calcimimetics, osteoporosis and chemotherapy agents for a wide range of malignancies. Additionally, she assesses drug safety on chemotherapy adjuvant drugs, as well as in hematology drugs such as WBC (G-CSF), EPO (ESA), and Platelet colony stimulators. She performed drug safety on a large variety of both post marketed drugs and drug compounds under clinical trial (protocol) review using a particular system. She also reviewed SMOC cases. Other duties included assessing drug safety with pregnancy related cases. She was involved in the Standard Query Project for standardizing the evaluation and reviewing the process of 75 of the most common adverse events.
She was performed secondary review of G-CSF, hematology drugs such as Neulasta, Neupogen, N-Plate, Aranesp, with related propriety compounds under clinical trial development in the areas of anti inflammatory, oncology and G-CSF stimulation.
Expert has served as a medical monitor and clinical development consultant for a company that focused on dermatology related drugs for the past two years. She performed a multi center study on complicated skin and skin structure infections using a new antibiotic class of generation molecule. She also oversaw protocol development, monitoring and responding to all AE/SAEs, protocol deviation, waivers and enrollment. She ensured the approval of both the IRBs and the FDA for the various clinical studies performed by the company. She also organized and planned regular meetings with the company’s investigators to present protocol and drug safety.
She helped in the development of adverse medication lists for trial sites including Seizure threshold, QTc interval and immunosuppressive. She performed study reconciliation, line listing review and data review for the various studies and worked as the sponsor’s delegated Medical Monitor interface with sites, monitors, registered with FDA as medically responsible for various studies.
Expert has been a consultant for a well-known pharmaceutical company consulting investigators on studies regarding complicated skin and skin structure infections as well as various other dermatologic conditions. She oversees the drug safety, acts as a Medical Officer and ensures all IRB requirements are met for each clinical study.
Expert may consult nationally and internationally, and is also local to the following cities: San Jose, California - San Francisco, California - Sacramento, California - Oakland, California - Stockton, California - Fremont, California - Modesto, California - Salinas, California - Santa Rosa, California - Hayward, California
|Year: 1984||Degree: B.S.||Subject: Biology||Institution: University of Utah|
|Year: 1988||Degree: M.D.||Subject: Medicine||Institution: University of Utah School of Medicine|
|Years: 2009 to Present||Employer: Undisclosed||Title: Medical Monitor||Department: Clinical Development||Responsibilities: Expert monitors new compounds for the treatment of oncology clinical development, reviews drug safety, summarizes and mediates between her pharmaceutical company and the FDA and also reviews data for each clinical trial.|
|Years: 2007 to Present||Employer: Undisclosed||Title: Drug Safety Analyst||Department: Drug Safety||Responsibilities: Expert reviews drug safety for drugs used to treat psoriasis, calcimimetics, osteoporosis and chemotherapy agents for a wide range of malignancies, chemotherapy adjuvant drugs and hematology as well as pregnancy related cases.|
|Years: 2007 to Present||Employer: Undisclosed||Title: Medical Monitor and Consultant||Department: Clinical Development||Responsibilities: Expert provides consulting services to investigators on studies regarding complicated skin and skin structure infections as well as various other dermatologic conditions. She oversees the drug safety, acts as a Medical Officer and ensures all IRB requirements are met for each clinical study.
|Years: 2007 to 2009||Employer: Isolagen Inc.||Title: Vice President||Department: Clinical Development||Responsibilities: Expert directed the management and clinical operations implementation of various phases within a particular clinical study. She also coordinated the presentations related to medical and financial conferences, including writing and submitting papers, abstracts and posters into key venues.
|Associations / Societies|
|American Academy of Family Practice, WA Academy of Family Physicians, Washington State Medical Association, American Academy of Dermatology, California State Family Practice Academy|
|Licenses / Certifications|
|Board certified by the American Board of Family Practice and American Board of Dermatology; Medical license to practice in the state of Utah (inactive) and Washington; Industry certifications include NIH and WIRB|
|Assistant instructor, Physician supervisor, attending physician at various hospitals, Principal and sub-principal investigator, Director and Physician Liaison for a Physician service group, Medical Research Director for an eyecare center, Director of Clinical Research for a pharmaceutical company, VP Medical Affairs and CMO of a pharmaceutical company, Senior Medical Monitor and Clinical Development|
|Awards / Recognition|
|Who’s Who in America, Who’s Who in America’s Women|
|Medical / Professional|
|1988-1991 Board Certified in Family Practice for rural LMD (Lone Medical Doctor) program. A program for training doctors to go into remote rural communities of 5000 or less and do everything.|
|Publications and Patents Summary|
|She has several publications in her area of expertise.|