Texas Biotechnology Work Values

Daily Duties at Texas Biotechnology:

Project Manager * Insured FDA/GCP/ICH guidelines are followed * Monitor and report adverse events, review CRFs * Prepared INDs, NDAs, amendments, supplements, manuscripts, abstracts, study reports * Coordinated project implementation and management * Initiated sites for clinical trials, evaluated site suitability * Prepare and follow project budgets and timelines, monitor progress * Recruit patients for clinical trials * Conduct project meetings and report progress to senior management * Data manager ╨ entered data into database * Managed 4 CRAs (Pharmaco / PPD) Medical Liaison * Found thought leaders, clinical trial coordinators, managed care organizations, academic and hospital institutions which may be interested in clinical research * Education: provide information about product efficacy, safety, mechanism of action, and how the drug compares to competing drugs; CME, identify research and clinical issues for product introduction, train sales force, attend investigator and science meetings * Sales support: help develop and increase market share, work with marketing to determine ways to extend product use and find additional therapeutic indications Clinical Research Associate * Resolved site queries * Clinical investigation site training * Ensured data is accurate, complete and verifiable, submit clean CRF * Drug accountability * Monitor clinical site activities, review study files Pharmacology Group Leader * Drug discovery: Tested drugs to treat restenosis, heart and renal failure, stroke * Tested various means of drug delivery (transdermal, liposomes, depot injection) * Worked with catheter companies to improve drug delivery (microporous and electrophoresis) * Tested stents (drug eluting, biodegradable) in peripheral arteries (with the Bioengineering Dept. of Rice University) * Licensed-in endothelin antagonist: Determined which therapeutic areas to screen drugs and developed animal models of acute renal failure, stroke, hypertension, and heart failure * Strategic planning committee to determine drugs and devices to in- or out-license * Managed research contracted to academic and contract organizations * Performed PK/PD, ADME studies for drugs of interest and the arterial penetration of labeled drugs, statistical analysis of data * Tested the nephroprotective effects of angiotensin converting enzyme inhibitors and angiotensin receptor antagonists, in rat models of end-stage renal disease * Tested antibodies and drugs to inhibit leukocyte integrins (VLA-4) and vascular cell adhesion molecule (VCAM-1), to treat acute and chronic inflammation (asthma, DVT, transplantation), using intravital microscopy in rodent post-capillary venules * Supervised 2 employees in research and managed the animal facility which had 2 employees

What they like about Texas Biotechnology:

Organizations with strong, centralized leadership are particularly attractive to you. You require a work environment with leadership that aggressively seeks to expand and grow the business and does so in a visible and decisive manner. In general you prefer to work in an environment in which there is a strong link between leadership, its actions, and a strong set of company-wide values.

Tags

MSL, Medical Writer, Clinical Project Manager, Drug Safety, Pharmacologist, Regulatory Affairs, Medical Science Liaison, Director of Clinical Research, Regulatory Affairs Manager, Compliance

Skills

Software Implementation, Requirements Analysis & Specification, Project Management, Medical and publication writing, Medical Science Liaison, Regulatory Affairs, Drug Discovery / Toxicology / PK/PD, Compliance

These are some of the questions we asked our climbers about their experiences with Texas Biotechnology: