Clinical Trials: Life Beyond Research and Development Kelly Philpot, PhD (2006) Clinical Research Associate II PPD, Inc. Kelly Philpot, PhD (MSP, 2006) Co-Mentor: Michael J. Kuhar, PhD Co-Mentor: Yoland Smith, PhD Dissertation: Characterization of CART-Containing Neurons in the Lateral Hypothalamus Therapeutic Significance: Drug Addiction and Feeding Behavior (Motivational Behaviors) Techniques: Immunocytochemistry observed with the light microscope and electron microscope, tract- tracing techniques, in-situ hybridization, rodent feeding behavior Two revelations. . . 1) Transferable skills 2) BIG Picture 1. Transferable Skills Academics Industry General writing and General writing and speaking opportunities speaking opportunities Grant writing FDA applications & Managing Protocol writing Teaching Managing Research Training Research 2. BIG Picture: Drug Development Infinite !!! 6-10 Years Primarily Non-Human Studies 20-100 100-500 1000-5000 Healthy Diseased Diseased Humans Humans Humans 2. BIG Picture: Drug Development Jack/Jill of All Trades Expert in One Area CRO vs. Pharma Company CRO = Contract Research Organization Contracted by Pharmaceutical Companies to run the clinical trials in a quick and organized fashion to. . . SAVE $$$$ = $$$ Broader range of opportunities in different therapeutics More opportunities to get a job at a CRO when someone is less experienced in clinical trials. Preparation while in PhD program Remember the BIG PICTURE! Show tangible activities of interest in business aspects of pharmaceuticals and clinical trials Take opportunities outside of your research Conducted a Phase IV clinical trial in the Himalayas on High Altitude Medicine Leadership and Business Development Skills Co-Chair for the Atlanta Biotech Network when it grew into a larger group named the Emerging Leaders Network (ELN) associated with the Georgia Biomedical Partnership Read books and search internet Independent study of Fundamentals of Clinical Trials, FDA regulations, and competitive companies and positions How I got my first job out of Emory! Getting the interview: Read books on how to interview properly Designed my CV to read more like a resume Invited numerous business contacts to “coffee” I had coffee with the head HR representative (a friend through a friend through a friend) at Kendle and my CV was put to the top of the pile. Getting the job, I had to focus on a lot more than just my research experience. . . Clinical Research Associate (CRA) Primary Roles: Ensure proper trial conduct Train staff at each doctor’s office (site) Timely generation and collection of quality data (data management) Protect subject safety Prepare site (doctor’s office) for potential FDA audit Overall quality control Clinical Research Associate (CRA) Personality: Self-starter, independent, self-disciplined Good interpersonal skills Excellent writing and speaking skills Flexible, adaptable to change Ability to travel without much added stress The PhD Candidate vs. The CRA PhD candidate CRA Independent worker Independent worker Developed writing and Developed writing and speaking skills speaking skills Attention to detail Attention to detail Commonly Introverted Extroverted Focuses on one aspect Works with a variety of of one therapeutic area mechanisms of action in various therapeutic areas 3 Days in the Life of Kelly. . . Average travel: 60-80% (2-4 days/wk) Day 1: 8:00 - 9:00am: Start work from home office Write reports from previous site visits, electronic data management, communicate with sites via email and phone 2:00 pm: Leave home to go to airport 8:00 pm: Get to hotel in another city 8:00 – 11:00 pm: Finish work and prepare for site visit the following day 3 Days in the Life of Kelly. . . Day 2: 6:00 am: Get ready for the day and get a little work done 8:00 am: Arrive at site for the visit Depending on visit: Interview a site for trial participation: 2 hours Train staff on a new trial: 4 hours Monitor progress of a trial: 8 hours Close-out a trial: 8 hours Travel home: 6 hours Day 3: Write report for previous day’s visit Continue cycle Salaries of CRAs CRA I : work in office, little travel ~40-50K CRA II: need at least 1 yr experience as CRA I and will travel (also have the potential to work out of home anywhere in US) ~55-70k (depends on company, location and experience) CRA III: need at least 2-3 years experience ~70-85K Sr. CRA: need at least 5 years experience $85K. . . Beyond The CRA VP or President of Company VP of Clinical Operations Global Manager Department Manager Project Manager CRA – 5 years Other Career Options in Industry Medical Science Liaison: Work for a drug company traveling to Dr. offices to discuss and understand the MD’s needs and thoughts on current medicines and trials. (not pharm sales!) Medical Writer: Designing, writing any documents needed for a clinical trial; no travel Data Management: very introverted; no travel Pharmacovigilance (AKA Safety): no travel Ethics Committees (IRBs): Independent safety agencies; no travel FDA: all types of jobs, working for government Research Scientist: available in industry and government jobs; no travel Do not be afraid. . . Get out there and learn about alternative careers in science ON YOUR OWN A PhD teaches you much more than just how to run a gel or grow cells Critical and Independent Thinking Research, speaking and writing skills Timeliness Be Proactive in your career Companies of Interest near Atlanta Pharmaceutical Companies (variety of jobs) Atlanta-based: UCB Pharma, Solvay, AtheroGenics etc! AtlantaTechnologyLoop.com: Large list of companies in area Contract Research Organizations (CRO) (variety of jobs, but little research opportunities) Quintiles Inc (office in Marietta) RTP, N. Carolina: PPD Inc; Kendle International; Covance, Parexel Biotech Companies (research-based jobs) Emtech Bio Briarcliff Campus http://www.emtechbio.com/ Recruiter specific for Scientific Positions KForce Resources you can Utilize NOW Georgia Biomedical Partnership Emerging Leaders Network http://www.gabio.org/content.aspx?pageid=12 email@example.com AtlantaTechnologyLoop.com Applied Clinical Trials Journal Free subscription to monthly journal http://actmagazine.findpharma.com/ Talk to professors with experience in industry Books of Interest If Entering Clinical Trial Realm Alternative Careers in Science: Leaving the Ivory Tower Cynthia Robbins-Roth Fundamentals of Clinical Trials Friedman, Furberg and DeMets The CRA’s Guide to Monitoring Clinical Research Karen E. Woodin, PhD and John C. Schneider Take Home Questions: What type of personality do you have? What interests you? One topic or a variety of topics? What will get you out of bed in the morning (on the right side of the bed)? Do you like to work in the lab? Teach? Manage? Write? Speak? Travel? All of the above? Remember. . . You may not get your dream job right out of graduate school, but at least have a 5-10 year plan on reaching that goal. Questions???
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