Bio

Marina Noble, MD, MPH

After earning her M.D, and with specialized clinical OB/GYN training, Dr. Noble began her career as an OB/GYN practicing in Yerevan, Armenia, where she treated gyn. patients with various conditions and regularly performed various and often major gynecological abdominal surgeries successfully for ten years.  Additionally, Marina worked with MSF (Doctors Without Borders) in Armenia providing education in the areas of reproductive health, STIs and HIV/AIDS.

Dr. Noble was a recipient of the Freedom Support Act Graduate Fellowship funded by the U.S. Congress in 2001, and completed her MPH at the Boston University School of Public Health in 2003.

Since then, Dr. Noble has worked extensively in the field of clinical research in the USA. She was the co-founder of Atlantic Clinical Research, LLC, and later opened her own research site.

Dr. Noble has had a diverse career within the field of medical/clinical research ranging form the management of clinical trials to the analysis, categorization, and reporting of data pertaining to the safety and efficacy of pharmaceutical products during clinical trials, and in the analysis of post marketing safety data.

Dr. Noble gained her early experience in the pharmaceutical industry as a Safety Scientist contracting with a major pharmaceutical company, and was involved in a Core Label update project. Her contract there was extended three times. After completing the project, she moved into her next position as a pharmacovigilance and risk management manager at another well-known pharmaceutical company, working on antibiotic development safety.

Later, maintaining product/risk logs and being responsible for the safety response to internal and external inquiries were just some of Dr. Noble’s responsibilities as Global Drug Safety and Risk Management Lead Safety Physician with a company focusing on products in hematology and oncology.

Dr. Noble’s next assignmrnt, during her employment as Medical Safety Director at a pharma company that was also focused on hemophilia and oncology products, Dr. Noble was responsible for safety surveillance, signal detection and risk management as well as communications with regulatory agencies for both existing and developmental products. Dr. Noble was responsible for reviewing reports of adverse events and determining all necessary steps to be taken including RMP, protocol and label changes.  She collected and reported all relevant data from various sources during drug development and post-marketing phases.  Notably, Dr. Noble provided safety expertise and input into the design of clinical programs as well as the preparation of and timely submission of regulatory documents to the various agencies.

While working as Brand Safety Leader for another large pharmaceutical company, Marina was the scientific/medical safety leader for various oncology products.  She located, interpreted and utilized all relevant safety data obtained from all available sources and led the Safety Management Team. Marina interacted with regulatory authorities and health care professionals on safety issues on a regular basis.  Additionally, Dr. Noble provided input regarding the handling of licensing activities, regulatory authority inspections, and project/product recall remedies.

Dr. Noble worked as a company-wide safety expert.  She reviewed clinical and non-clinical safety data, developed all necessary documentation and was involved in many decisions including those related to dose escalation.

At Her most recent position, Dr. Noble was responsible for pharmacovigilance for both marketed and investigational products. She analyzed data from clinical trials and post-marketing sources and kept higher management informed of any and all safety issues.

In all the positions she has held, Dr. Noble has established solid working relationships with all cross-functional teams and has interacted with them at various levels.  She has also shown herself to be a mentor and coach willing to share her wide range of expertise with others.  Dr. Noble’s passion lies with the collection and interpretation of data and the safety of patients to whom medicines are administered, and specializes in benefit-risk management. She has been successful in providing strategic safety leadership in the development of risk management plans, global filings, new drug approvals, and product launches for several drugs in the oncology, hematology and rare disease therapeutic area. Dr. Noble’s expertise and input in the strategic handling of matters involving drug safety has been highly valued in the design and execution of clinical studies, and in all phases of product development and critical assessment of post marketing data since entering the field in 2006.