Clinical Research Scientist

Clinical Research Scientist Our client is a specialty pharmaceutical company.  Due to their ongoing growth, they have created a new "hands on" Clinical Research Scientist role, reporting to the Senior Director, Clinical Research and Development.  The Clinical Research Scientist will assist in the planning, implementation, managing, and reporting of clinical trials. He/She will prepare/review clinical trial synopses and protocols, Investigator Brochures, and clinical study reports; review SAPs and tables, listings, and figure shells; assist with data interpretation and data mining; ensure that assigned studies are conducted according to GCPs and Departmental SOPs; assist in conducting literature searches/reviews, meta-analyses, and publishing data; provide scientific expertise to product teams; contribute to the preparation of IND/NDA medical sections; support business development activities by evaluating new product potential; and will assist in the review of clinical study entries (clinical trial information and results) for posting to the company’s CTRR (Clinical Trial Registry and Results) database/TPR (Third Party Registry).  The position requires an advanced degree (Dr.P.H., Pharm.D., Ph.D., Sc.D.) as well as experience in pharmaceutical research, specifically exposure to the IND/NDA approval process and Phase I, II, III and IV clinical research. The incumbent should have at least 3+ years of directly related pharmaceutical clinical research experience. The position requires research administration experience, knowledge of scientific principles of controlled trials, and a comprehensive knowledge of FDA and ICH guidelines. Excellent human relations and communication (written and oral) skills are required. This position also requires a working knowledge of software packages (e.g., MS Word, MS Excel, MS Project, MS Access, JMP). The abilities to work on a team, cooperate with colleagues, and effectively communicate with a diverse audience, at multiple levels, both inside and outside the company, are essential. A capability to work with cross-functional teams at the protocol and clinical program level is mandatory. The incumbent must have demonstrated experience in clinical research, study trial management, clinical database maintenance, generation of research hypotheses, and publication and presentation of scientific information. Professionalism, objectiveness, critical thinking, evidence-based reasoning, and a positive outlook are of the utmost importance. CNS-, pain-, and/or neurology/neuroscience-related research experience is highly desirable. Travel up to 20% of the time may be required.  Do you have the skills and experience we seek and want to advance your career with a well-established, innovative and growing company?  If so, please email your resume as a Word attachment to dan@jobsrecruiting.com , Reference code 2190-M.  No calls or faxes, please.  Include your daytime phone number and we will contact you confidentially or reply to your email. Fairway Consulting Group is a leading executive search firm dedicated to the pharmaceutical and biotech industries.  www.jobsrecruiting.com or www.fairwayconsultinggroup.com MRINetwork is the largest and most successful search organization in the world. Each MRINetwork office is a single point of contact to over 1,100 offices in more than 37 countries, our candidates have access to the right jobs virtually anywhere in the world. LOCATION: US-PA-Philadelphia JOB CATEGORY: Biotech/R&D/Science TYPE: Full Time, Employee JOB REFCODE: 2190-M COMPANY: Fairway Consulting Group ADDRESS: 300 Merrick Road - Suite 404Lynbrook,NY 11563 PHONE: 516 596-2800 EMAIL: Apply by Email