ACRP event: Conducting Research to Support Device Development

There's an ACRP meeting in Philadelphia titled, "Conducting Research to Support Device Development."

This will be a Presentation by:
Stephen Wilcox, Ph.D, FIDSA
Principal, Design Science

Date: Wednesday, November 6, 2013
Time: 6:00-8:00pm (dinner provided)
Location: Children's Hospital of Philadelphia
CTRB Building 4th floor #4040

So, whether you have an interest in clinical research or medical devices, this event could be highly educational for you. Plus, I'm sure it will be a great networking event. Look for local ACRP chapter activities in your area.

CLICK HERE for more information and to register for this event!

Job Post: Oncology Clinical Research Physician

Job Post: Oncology Clinical Research Physician

Responsibilities

The Oncology Clinical Research Physician (CRP) will combine scientific and clinical expertise with his/her passion for helping cancer patients to make meaningful differences to the lives of many people. He/she helps create solutions for patients, health care professionals, and caregivers that have broad impact across the world.

He/She participates in the development, conduct and reporting of local clinical trials; the implementation of global clinical trials ; the reporting of adverse events as mandated by corporate patient safety; review process for protocols, study reports, publications and data dissemination for products; medical outreach, and various medical activities in support of demand realization.

The CRP is an integral member of the Oncology brand team for strategic planning in the support of launch and commercialization activity and may work with Development team(s), Therapeutic Area Program Phase, Early Phase /Exploratory Program Medicine (EPM), and Translational Medicine team(s) in new product development activities over the entire spectrum of drug development and clinical trial phases.

Core Job Responsibilities

The primary responsibilities of the Oncology Medical Affairs CRP are generally related to late-phase and marketed compounds. The CRP is responsible for collaborating with local research staff in the planning, startup and conduct of phase 3b/4 studies. The core job responsibilities include those listed below as well as all other duties as assigned.

Job Post: Biostatistician/Director of Biostatistics

Job Post: Biostatistician/Director of Biostatistics for a Contract Research Organization (CRO)

Location: variable

-Client facing
-Experience with FDA submissions – NDA, INDs
-3 plus years of Biostats experience in a pharma/CRO
-experience in Phase I,II, III clinical trials
-experience with CDISC
-PhD preferred

Contact: paul.s.kim@us.ibm.com

Certification in clinical research

The Association of Clinical Research Professionals (ACRP) provides certification: formal recognition of clinical research professionals who have met eligibility requirements and demonstrated specific, job-related skills.

Learn More About: CRA Certification; CRC Certification; PI Certification; CTI Certification

For employers, Certification can serve several purposes from providing evidence of experience and qualifications of a research team to the FDA, or other regulatory bodies, during an inspection, to validating competency when considering a new employee. Recently, evidence has indicated that regulators believe Certification reduces risk to research subjects. There are fewer errors, lower costs, more rapid turnaround, and greater safety in clinical trials when Certified professionals are involved.

Since 1992, the Association of Clinical Research Professionals (ACRP) has been the leading certifier of clinical research professionals with more than 25,000 professionals holding a designation from our accrediting bodies to date.

http://www.acrpnet.org

Clinical Research Professionals Marketplace

The Association of Clinical Research Professionals (ACRP) has recently launched the Clinical Research Professionals Marketplace.

This serves the clinical research enterprise and features searchable profiles and contact information for companies offering specialty services in five categories: Business Services, Contract Research, Educational Services, Information Technology, and Site Services.

The ACRP Clinical Research Professionals Marketplace serves the breadth and depth of the enterprise devoted to the development of new drugs, medical devices, and therapeutic approaches—from the needs of academic medical centers to training providers, institutional review boards to electronic data capture services, project management to translation professionals, patient recruitment to staffing specialists, laboratories to pharmacovigilance units, and more.

ACRP articles on research careers for physicians working in industry

The Association of Clinical Research Professionals (ACRP) has several interesting articles in the April issue of the Monitor.

You can read the article by opening the link here and then skipping to page 21 where you will find an article written by Jonathan P. Gertler, MD titled, "Pathways, Strategies, and Contributions for MDs in Industry."

On page 25, you'll find an article titled, "A Close Look at Medical Writing."

You can also read the Sept 2011 issue of the Monitor that is focused on Careers in Clinical Research.

Job Posting: Medical Research Specialist

Medical Research Specialist
Physicians Committee for Responsible Medicine - Washington, DC 20016

The Physicians Committee for Responsible Medicine is a nonprofit organization working toward compassionate and effective medical practice, research, and health promotion. For the last 27 years, PCRM has led the way for reforms of federal nutrition policies, and our clinical research programs are breaking new ground in diabetes, cancer, and other serious medical conditions. We have fought for an emphasis on prevention, higher ethical standards in research, and scientific advances in basic research and effective drug development. Over the years, we have taken on battles to end ethically questionable experiments involving children and inhumane animal experiments and have worked to improve science education. We have worked with physicians, federal regulators, politicians, researchers, educators, students, and concerned citizens. And we have so much more work to do.

PCRM is seeking to hire a Medical Research Specialist to play an integral role with our work advocating for nonanimal research methods. This means evaluating specific uses of animals in research, understanding methods of research that do not involve animals, and working with decision-makers and the press to promote ethical research.

J&J Opens Janssen Labs at San Diego

Janssen Research & Development, LLC Opens JANSSEN LABS at San Diego

Novel Life Science Innovation Center to spur science by supporting early-stage life science industry

SAN DIEGO, Jan. 17, 2012 /PRNewswire/ -- Janssen Research & Development, LLC, (Janssen) today opens Janssen Labs at San Diego, a 30,000-square-foot life science innovation center, located within the company's Janssen West Coast Research Center. The innovation center provides a capital efficient, flexible lab environment for start-up companies pursuing new technologies and research platforms to advance medical care.

"A thriving biotech ecosystem is crucial for the success of the pharmaceutical industry as a whole," said Diego Miralles, M.D., site head for the West Coast Research Center. "Recent challenges in the economic environment have made it difficult for many emerging biotech companies. We believe that supporting and nurturing these companies will be good for the entire industry."

ACRP Certification

Find out what more than 25,000 clinical research professionals already know. Earning your designation demonstrates you have achieved the clinical research industry's premier Certification. This career milestone will validate your clinical research knowledge, skills, and application — apply for Certification today.

CCRA® — Certified Clinical Research Associate
CCRC® — Certified Clinical Research Coordinator
CPI® — Certified Physician Investigator

Benefits of Certification include:

• Evidence of experience and qualifications of a research team
• Validation of competency when considering a new employee
• Reduction of risk to research subject
• Recently, evidence has indicated that regulators believe ACRP Certification Programs result in fewer errors, lower costs, more rapid turnaround, and greater safety in clinical trials when Certified professionals are involved. 

Since 1992, the Association of Clinical Research Professionals (ACRP) has been the leading certifier of clinical research professionals with almost 24,000 professionals holding a designation from our accrediting bodies to date.

ACRP 2012 Global Conference

Register for the ACRP (Association of Clinical Research Professionals) 2012 Global Conference & Exhibition by December 31 and save $200 with Early-Bird rates.

ACRP 2012 Global Conference
April 14-17, 2012 – Houston, Texas, USA

The program for the ACRP 2012 Global Conference features more than 125 sessions covering 12 Topic Areas – all delivered by leading speakers.

You can register for ACRP 2012 here.

Experience two sesssions from the ACRP 2011 Global Conference & Exhibition for FREE through April 1, 2012. Free sessions include:

• Innovation & Global Health, featuring Tachi Yamada, MD, President, Global Health Program, Bill and Melinda Gates Foundation
• Regulatory Affairs Public Forum, featuring representatives from global regulatory agencies addressing issues facing clinical trials

You can view these sessions here.

The BioCapital Career Fair is Coming Up

Looking for a job in the biopharma industry? A career fair is a good place to find a variety of different opportunities for physicians and scientists interested in working in the biotechnology or pharmaceutical industry.

BioCapital Career Fair
Tuesday, November 1, 2011
11am to 4pm
Bethesda North Marriott & Conference Center
Bethesda, MD

Spend the day speaking with representatives from top biopharmaceutical companies in the area. Face time is hard to get in today's world of technology, so take advantage of this great opportunity to speak with HR reps and hiring managers in person!

Amgen laying off about 380 R&D workers

According to this story on the Los Angeles Times, Amgen is cutting jobs in research and development (R&D).

The layoffs represent about 6% of Amgen's total 6,700 workers in research and development. Amgen employs about 17,600 workers globally.

A number of years ago, physicians and scientists who worked in R&D had a level of job security that pales in comparison to today. Changes in the global economy along with regulatory challenges in drug development have led to cuts in R&D in many biopharmaceutical companies.

R&D opportunities with AstraZeneca

Every day, AstraZeneca takes on scientific challenges that can seem insurmountable. But working together, our 62,000 people constitute one of the most formidable research and development communities ever created. And with that kind of team behind you, just think what's possible.

The following specialists are needed to enhance our team. Bringing both fresh thinking and deep experience, you'll help us work towards a shared future of better public health.

Senior Medical Director -- Anti-infectives Patient Safety
Wilmington, DE; Requisition #: 602372
You'll ensure that all safety surveillance activities are conducted to the highest ethical and safety standards, in compliance with GCP and regulatory requirements. You'll help set the strategic direction for patient safety surveillance and make vital decisions on product safety profiles.

Director/Assistant Director -- Health Economics & Outcomes
Wilmington, DE; Requisition #:601574
Focused on maximizing the commercial success of products throughout their lifecycle, you will design and implement innovative research activities and produce scientific evidence to optimize price and value propositions. In-depth, specialist knowledge of health economics and outcomes research and its application to pharmaceutical development is essential.

Drug Development Boot Camp at Harvard University

Drug Development Skills are Difficult to Acquire

DRUG DEVELOPMENT BOOT CAMP
NOVEMBER 9-10, 2011
THE HARVARD CLUB • BOSTON, MA

The pharmaceutical industry has its fair share of Ph.D.s, and MDs, and yet qualifications do not translate into understanding of the drug development process. In fact, Nobel Laureate scientists find the drug development process bewildering.

As drug development costs increase, the process of drug development is becoming more and more complex. Those involved with the process of developing new therapeutics (drugs, devices, combination products and diagnostics) must understand the process and be able to navigate it with great skill. These skills are difficult to acquire.

ACRP 2011 Global Conference Virtual Session

For the first time ever watch sessions from the ACRP (Association of Clinical Research Professionals) Global Conference & Exhibition live or on-demand without the need for travel.

Earn 6 Contact Hours (Accreditation Information) while virtually attending 6 Conference Sessions from highly-rated speakers, all at your convenience.

Live video sessions will begin promptly as scheduled. Archived on-demand versions will be available within 24 hours of the original broadcast.

$299 Member Price | $599 Regular Price
A link to access live and on-demand sessions, handouts and evaluations will be included in your confirmation email after purchase. Archived sessions will be available through August 8. Only the purchaser is eligible to receive contact hours, and evaluations for contact hours must be completed by August 8.

The following sessions are included in the ACRP 2011 Global Conference Virtual Session Package:

• Implementing FDA/OHRP Training Standards: Are You Compliant?
• So You Think You Know GCP...
• FDA/OHRP Update
• Fast Track to Success for New Clinical Research Coordinators
• US Healthcare Reform's Continuing Impact On Our Industry
• Increasing Predictable Site Enrollment Success

How to break out of academic medicine to enter industry

Let’s face it: academic physicians often face burnout and many of them get called from recruiters about non-clinical opportunities in pharmaceutical research, biotechnology drug development, etc. How does an academic physician break out of the world of academic medicine? Is it as simple as applying for a pharmaceutical job online? Do you simply trust what you hear from an executive recruiter?

The entire process of breaking out of academic medicine and transitioning into industry can be quite complex if you’re trying to negotiate the optimal package that makes the most sense for you to leave academia. How strong are your corporate leadership skills? What is your value proposition? How do you negotiate your salary? Who else is applying for the position? Are you truly a competitive job candidate given the fact that many other seasoned physician executives may have many more years of industry experience?

Good Clinical Practices: Guide to Compliance

What do you know about GCP or Good Clinical Practices?

Here's a book by Barnett Educational Services titled, "Good Clinical Practices: Guide to Compliance"

Good Clinical Practices: Guide to Compliance, provides clear recommendations for full compliance with global regulatory requirements. The Guide includes templates for SOPs and other forms that can be copied and used directly in the GCP environment, including a full set of GCP inspection sheets.

This report will be available in electronic format and includes chapters and appendices covering the following information:

* Comparison of International GCP Regulations
* Regulatory Submission for GCP Data
* Critical Compliance Issues
* Internal and External Inspections and Audits
* SOP Templates

If you're interested in learning more about Good Clinical Practices, make sure to read some of these other books as well:

Pharmacovigilance Jobs

Are you interested in finding a Pharmacovigilance Job?  Let's begin by taking a look at the word "Pharmacovigilance." Here's what Wikipedia has to say about it:

Pharmacovigilance (abbreviated PV or PhV) is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines. Generally speaking, pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to:

* identifying new information about hazards associated with medicines
* preventing harm to patients.

The etymological roots are: pharmakon (Greek), “drug;” and vigilare (Latin), “to keep awake or alert, to keep watch.”

Top 10 Contract Research Organizations

Here's what Wikipedia has to say about Contract Research Organizations (CROs):

A Contract Research Organization, also called a Clinical Research Organization, (CRO) is a service organization that provides support and/or services for clinical trials. CROs support the pharmaceutical, biotech and medical device industries as well as foundations, research institutions, and universities, in addition to governmental organizations (such as the NIH, EMEA, etc.). There are over 1,100 CROs in the world. It is a very fragmented industry with the top 10 controlling 56.1% of the market in 2008. One estimate had the size of the market set to reach $24 billion in 2010 and set to grow at a rate of 8.5% through 2015.

Top 10 CROs:

1. Quintiles ($2.5 billion)[2][6]
2. Covance ($1.8 billion)[2][6]
3. Pharmaceutical Product Development (PPD) ($1.4 billion in sales)[2][7]
4. Charles River Laboratories (CRL) ($1.2 Billion sales)[6]
5. Parexel ($930 million in sales)[6]
6. ICON ($887 million)[8]
7. Kendle ($590 million in sales) [6]
8. Pharmanet ($470 million in sales)[6]
9. PRA International ($410 million in sales)[6]
10. Aptuit ($370 million in 2009)[6]

Featured physician executive: Silvia Zieher, M.D.

Each week, we feature a physician executive. This week's featured physician executive is Dr. Silvia Zieher.

Silvia Zieher, MD
Executive Director, Clinical Development, Latin America
INC Research, Inc.

Dr. Zieher has 15 years experience in clinical research as clinical team leader, clinical development manager of a top ten pharmaceutical company in Argentina and as a CRO clinical research director and head of clinical operations for Latin America. She joined the CRO industry in 2004.

Her responsibilities have included operations and project leadership activities related to the conduct of global clinical trials and the implementation of studies in Latin America. She has had direct line management responsibility of project teams. She has contributed to the development of training, quality control activities and development of processes and SOPs at the regional and global level. She has served as the the local safety officer with pharmacovigilance responsibilities for a pharma country affiliate. Dr. Zieher contributed to the preparation of the PAHO (Pan American Health Organization) guidelines: titled: “GCP: Document of the Americas” that was published in 2005, being the FIFARMA (Latin America Global Pharma industry) representative of the GCP expert working group at PANDRH (Pan American Network for Drug Regulatory Harmonization). This guideline is the foundation of all new regulations in Latin America. She has conducted academic activities in clinical research and is a frequent presenter as international conferences as DIA.

Prior to entering the pharmaceutical industry, she worked for 8 years as a pediatric physician public and private institutions in Buenos Aires, Argentina, and taught at the Faculty of Medicine of the University of Buenos Aires, where she also completed postgraduate studies in clinical pharmacology.