Posts Tagged Biotech, Pharma & Medical Device News
Scientists discover cellular level bond between mother & child – see my limerick below that I wrote after reading this interesting research article – http://bit.ly/SPTGbL
Between a child and a mother
A deep bond like no other
Microchemeric cells giving her immunity
Even as she looses her sanity
For, compared to raising kids, every other task’s far simpler!!
For the opportunities below, please send resume to wd_darshana at hotmail dot com. Candidates must be based in the USA and have valid US work visa. More opportunities will be added soon.
Clinical Data Manager – Redwood City, CA
There is an immediate opening for Clinical Data Manager for San Carlos, CA based medical device company. Responsibilities include, design, develop and enhance clinical databases and data reports and perform validation of databases and reports to ensure data accuracy, completeness and integrity of data entry, discrepancy database management, study documentation and data auditing. Job functions include, participating and providing support for data management activities, investigator meetings, DSMB meetings and regulatory submissions, assisting study team with the preparation of data collection forms and charts for the reporting of research data, supporting international and FDA regulations and company goals, policies and procedures, and complying with Quality System.
Requirements include, knowledge in regulatory requirements, FDA, ICH, GCP etc. guidance, experience using Commercial Off the Shelf Clinical Data Management and/or Electronic Data Capture products (e.g. Clindex, Oracle Clinical, Phase Forward, eTrials, etc.) is required. Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) is a plus. Also required, a Bachelor’s degree in related field with minimum 3 years experience in clinical data management supporting clinical trials, including experience in regulatory submission of drugs or medical devices (510K, class III devices, PMA).
Sales Rep Opportunity – Orange County, Los Angeles, CA
This position will play a visible role in drug rep industry, by developing critical relationships, primarily with doctors of many disciplines to share the availability of breakthrough pharmaceutical grade pain management option that would diminish pain, aid in sleep, and enhance quality of life as a holistic alternative to addictive and sometimes life threatening drugs. Specific responsibilities will include, provide field based scientific exchange and communication regarding the product, broad interdisciplinary background and proven ability to establish relationships with doctors across variety of disciplines, tenacity and drive to reach out to new doctors, and ability to work the referrals, and to network and partner with medical practitioners. Requirements include, pharma or medical industry sales background, strong sales success track record, consummate professionalism including understanding of sensitivity of subject along with ability to deal warmly with high powered, industry-leading medical professionals, strong entrepreneurial spirit and passion for the vision of managing pain with a holistic alternative. Compensation will include commission, bonuses, and stock options during the first 60 days and then will include cash based compensation. This position is located in Los Angeles, Orange County, CA.
Non-Clinical Safety Evaluation for Drugs and Medical Devices – talk at www.bio2devicegroup.org by Michael Taylor, January 17, 2012
Posted by Darshana V. Nadkarni, Ph.D. in Uncategorized on January 19, 2012
Dr. Michael Taylor discussed the interactive nature of drug and device development and the role played by pharmaceutical toxicology. Drug development process takes new chemical compounds through considerations regarding formulations, safety of materials used, effects of molecules inside the body, toxic effects etc. Toxicology is the most time and resource consuming component. Goal of pharmacological toxicology is often to minimize spend and kill a molecule sooner, rather than later. However, that is not the only goal. Sometimes the goal is to understand and identify things like, safe dose, impact of harmful interactions, identifying potential target organs and so on. In the end, it is about balancing risk and benefit.
What needs due consideration is what exactly is being developed. Is it small molecule, biologic, device, combination product, approval of drug device material, new usage, new indications, change in delivery route, new manufacturing process, new impurities, target population? Each of these considerations will have its own unique parameters. For instance, if the drug in development is an end of life drug then different considerations will go into effect compared to a drug that is targeting relatively mild condition. Early considerations must begin with solid review of literature, review of FDA approved summaries and screening data, and receptor profiling. The presentation ended with Q&A.