SUMMARY:

• Diligent, enthusiastic and very goal oriented medical scientist with significant corporate experience in Preclinical and Clinical research, Product development, Competitive landscape evaluation, Key Opinion Leader (KOL) liaisons, plus hands - on surgical and interventional skills. As science coordinator of the New Ventures team at Confidential, I worked with a diverse group of engineers, chemists, scientists, marketing staff and KOLs, to develop products from brain-storming sessions, through proof-of-concept, preclinical and clinical evaluations. I am very technically and solution oriented, plus passionate about working on industry leading concepts.
• I routinely submitted non-disclosures for new concepts and earned several patents. I wrote all protocols, reports, presentations, conference articles, inter alia, on the preclinical and clinical aspects of projects that I led. Currently working as a remote medical writer for preclinical and clinical projects (Phase I - III) requiring submission to regulatory bodies.

TECHNICAL SKILLS:

Skills: Medical Writing Research scientific and technical background information, establish objectives, design protocols, formulate methods, collect, compute and summarize data, analyze and describe findings, generate conclusions, compare to previous findings, plus suggest recommendations, as guided by established practices and regulatory agencies. Preclinical & Clinical Research - Protocols, PI liaisons, Study Site inspections, GLP & GCP data, Reports Surgery - Experienced Interventionalist, performed hundreds of procedures on various large animal models. - Catheter assisted delivery of stents, pacemakers, coils, valve prosthesis, stem cells, balloons, echo. - Assisted in the preclinical evaluation of off-pump cardiac surgery devices, and human surgeries. - Competent with various diagnostic & imaging equipment including; fluoroscopy, Echo, CT, MRI In-vitro Cell and tissue culture, creation and use of synthetic models for the evaluation of various devices

WORK EXPERIENCE:

Confidential, Mountain View, CA

Responsibilities:

• Remote Medical Writer. Independent contractor writing routine, GLP and GCP protocols, data computation, result analysis and reports for various preclinical and clinical trials performed at the CRO and other external institutions by third party companies, for submission to scientific and managerial teams, the FDA and other regulatory bodies.

Confidential, Santa Clara, CA

Responsibilities:

• Senior Medical Writer and Clinical Research Associate. Responsible for writing and reviewing protocols, informed consent, data collection documents, reports, scientific communication with external KOLs, abstracts, posters, manuscripts, and intellectual property submissions. Also responsible for maintaining compliance with regulatory requirements, plus coordinating aspects of clinical trials in accordance with standard regulations such as GCP. Worked specifically on Phase 1 submissions of stem cell therapy for the treatment of heart failure in Europe and the USA, plus Phase 1 trials of bioresorbable, drug-eluting, intra-vascular stents

Confidential, Santa Clara, CA

Study Director and Principal Research Scientist

Responsibilities:

• Vulnerable Plaque Studies. Worked with external KOLs on studies to identify clinical Confidential ts with vulnerable vascular plaque for potential early intervention using proprietary devices and agents. Created animal models of atherosclerosis and used them to evaluate devices and agents that could stabilize vulnerable plaque or reverse atherosclerosis.

Confidential, Santa Clara

Senior Preclinical research Scientist

Responsibilities:

• Drug Eluting Stents Program. Implanted stents in animal models to evaluate their deliverability, structural performance, safety, efficacy plus the pharmacokinetics of the eluting drugs.
• Heart Failure Program. Created in-vivo models of myocardial infarction, ischemic and congestive heart failure. Evaluated the delivery and retention of microspheres and labeled cells into the myocardium via various catheters and surgical delivery systems.
• Mitral Valve Regurgitation (MVR) project. Created models of MVR using rapid pacing, targeted ischemia and cord ligation. Evaluated regurgitation and cardiac performance via echocardiography. Delivered prosthetic devices in the coronary sinus and left atrium to correct for MVR.
• Cell culture Lab Supervisor. Supervising a team of scientists working on the in vitro and ex-vivo evaluation of drugs, polymers and devices using human, porcine and murine cell lines, and tissues, via a wide variety of laboratory techniques and instruments. Supervisory duties included employee management, project overview, scheduling, budgeting, technical advising and conflict management.

Confidential, Montgomery, TX

Responsibilities:

• Scientific Consultant. Helped to set up the research and development laboratory of a new biotechnology company. Designed and implemented a validated HPLC assay to study elution patterns from drug coated intravascular stents and liposomes. Formulated coating patterns, drug extraction methods, configured the HPLC’s parameters and all laboratory equipment for routine use.

Confidential, Houston, TX

Responsibilities:

• Biochemistry Instructor. Taught molecular biology and biochemistry lectures and laboratory classes.

Confidential, Houston, TX

Responsibilities:

• Associate Professor in Biology. Taught Immunology, General Biology and Anatomy.