The following career opportunities were posted this week at DNAjobs.com. For each position, I have listed a short description and a link for more information.
As always, I wish you tremendous success in your searching!
Jason
Sr. Manager - Publishing and Data, Submissions and Documentation
(US-New Jersey) Provide electronic publishing expertise to support electronic submissions to the FDA. Actively promote, plan for and implement publishing initiatives in support of the drug development process. Act as a reference point for all regulatory guidance&#-110s related to electronic submissions. Provide and develop training programs for Regulatory Associates as related to Electronic Submissions. Responsible for monitoring documentation standards to ensure compliance with FDA Regulations for successful electronic filings of all types from company. PRINCIPAL ACCOUNTABILITIES: Day to day management of publishing functions and planning of activities/timelines and resources on a proactive basis to support US submission timelines. Troubleshoot system/software problems as related to electronic submissions within Regulatory Affairs. Support, promote and provide training, as needed, for e-tools-as related to electronic submission work. Work to establish a Publishing Team and support implementation initiatives of a global document management and publishing system. JOB REQUIREMENTS: BA/BS degree in health sciences/computer science or related area with a minimum of 5 years of proven experience directly with submission production, preferably in a Regulatory Affairs Group. Strong understanding of the drug development process, pharmaceutical business and an excellent understanding of the structure and processes used to develop submission related documents. Previous background in the training of others on technical issues preferred. Previous supervisory experience required. Some knowledge of basic Pharmaceutical Record-Room Management principles and procedures. Solid expertise with publishing tools-Mastery of Documentum Knowledge of all file formats for submission inclusion. Abreast of all latest developments in ICH, CTD, XML-etc-and the ability to stay up-to-date with ever changing industry standards as impacted on electronic filings. Basic knowledge of printing capabilities with Docutech 6180. Excellent Pharmaceutical Company with Outstanding Benefits.
(Canada) Research & Development Interest - Clinical Operations Description: Clientis looking for a talented and enthusiastic individual to join their Clinical Operations. Reporting to the North America Head Biostatistics, Clinical Operations department, you will have the following responsibilities: Provides programming support to statisticians. Develops, tests and validates adequately documented programs for analysis files, production of tables, listings and figures according to the SAP and statisticians' requirements. With supervision by a statistician produces statistical outputs (tables, listings, graphs) included in the Integrated Statistical/Clinical report (ICSR). Ensure statistical programmes are developed, tested, and validated prior to target analysis date. Participates, if appropriate, as a member of the Clinical Team accountable to the statistician for all project issues. Maintains and archives program documentation for each clinical trial - both electronic and paper - in an appropriate manner. Requirements: The successful candidate will possess: M.Sc. degree in Statistics, Mathematics, or Computer Science. Minimum three (3) years of SAS programming experience in related industry. Strong background in Statistics, familiarity with Proc Report, and good SAS graphic skills. Knowledge of SAS software, including macros programs development, and awareness of current features in SAS. Ability to work in a team environment. Good oral and written communication skills are essential.
Clinical Pharmacokinetics Laboratory Director, Dept. of Pharmaceutical Sciences
(US-Tennessee-Memphis) St. Jude Hospital is dedicated to providing unsurpassed patient care and to advancing the health of children through biomedical research. Currently, St. Jude Children’s Research Hospital has an opening for a Clinical Pharmacokinetics Laboratory Director, Department of Pharmaceutical Sciences. This newly-created position will be responsible for the accurate and efficient performance of work assignments in the Clinical Pharmacokinetics (PK) Laboratory, including quality control, competency assessment, proficiency testing, regulatory requirements, and instrument maintenance. Maintains extensive knowledge and expertise in current and emerging therapeutic drug monitoring techniques, including pharmacogenetic tests. Responsible for the successful migration of specific laboratory tests from protocol-only research applications to clinical applications. Assists departmental faculty in assay implementation and validation functions of the Cancer Center PK Shared Resource, Translational Trials Unit Core Pharmacology Lab, and the Solid Tumor Pharmacology Core Lab. Because this is a new position, there is the opportunity to individualize the position, based on the candidate's strengths, and to participate in research projects. Ensures performance of all quality management procedures as required by the hospital and the accrediting/licensing, funding and regulatory agencies. Performs other related duties as assigned in order to meet the goals and objectives of the department and the institution. The successful candidate will have the following requirements: * A Doctoral-level (PhD, MD, or PharmD) degree in a related field is required. * Formal training in clinical pharmacokinetics is preferred. * Five (5) years of laboratory experience is required of which at least two (2) years must be in therapeutic drug monitoring or a related discipline. * Experience in molecular biological techniques preferred.
Post Doctoral Research Scientist – Genetics of Coronary Heart Disease
(US-New York-New York City) Key Responsibilities: 1.Will be responsible for identifying loci and ultimately genes for cholesterol, triglycerides, HDL and LDL levels in target population data. 2.Significant work has been done using mouse models of atherosclerosis to identify modifier loci. Position will translate these findings to humans. 3.Will do computer mapping of genes associated with disease susceptibility, and assess genetic variation using micro satellites and/or SNPs. Also facilitation of mutation detection, mutation cloning, creation of expression vectors, and transfection studies in tissue culture systems. 4.Will study gene and mutation functions in vivo by making transgenic, knockin or knockout constructions to produce induced mutant mouse models. Follow-on work will then be conducted to study the new mouse strains created. Job Requirements: 1.PhD from an accredited U.S. university. PhD graduates from non-US universities will only be considered if the university is internationally recognized for excellence. 2.Strong English verbal and written communications skills. 3.At least 1 “first author” publication in a high-profile peer-reviewed journal. 4.Demonstrates both ambition and an interest/ability to be a “self-directed” researcher. Experience: 1. Prefer 1+ year’s research work with emphasis on human or animal genetics research. 2. Must have: Experience with computer programs that identify gene linkage or association with a phenotype (disease). Extensive molecular biology experience, including cloning skills, RT-PCR, RNA quantitation. Experience with detection of genetic markers, micro-satellites and/or Single Nucleotide Polymorphisms. 3. Consideration will be given to candidates with expertise in mouse genetics and/or physiology that want to learn human genetics. 4. Prefer experience in the genetics of atherosclerosis or genetic analysis of other complex diseases such as cancer, mental illness, etc. 5. Prefer experience in atherosclerosis research involving lipoproteins and/or vascular biology. 6. Prefer experience with transgenic and gene-targeted mouse models.
Post Doctoral Research Scientist – Mouse Models of Diabetic Complications
(US-New York-New York City) Key Responsibilities: 1. Create mouse models of atherosclerosis (such as the LDRL receptor knockout mouse) and cross them with mouse models of hyperglycemia and insulin resistance. 2. Will supervise 1 research technician to manage and characterize the mouse colony both genotypically and phenotypically. 3. Assess models of diabetic macrovascular disease regarding: Metabolic parameters, such as lipoprotein, fatty acid, glucose and insulin levels. Vessel wall pathology, such as lesion size and quality. Vessel wall cell gene expression patterns. 4. After achieving the goal of building a mouse model in which diabetes greatly worsens atherosclerosis, will study the mechanism of the effect in depth. 5. Will create DNA constructions for new models as necessary. Job Requirements: 1. Education: PhD from an accredited U.S. university. PhD graduates from non-US universities will only be considered if the university is internationally recognized as being equivalent in excellence and stature to U.S. universities. 2. Strong English language verbal and written communications skills. 3. At least 1 “first author” publication in a high-profile peer-reviewed journal. 4. Demonstrates both ambition and an interest/ability to be a “self-directed” researcher. Experience: 1. Must have experience/career emphasis on human or animal genetics research with highly developed molecular biology skills. 2. Must have experience with computer programs that identify gene linkage or association with a phenotype (disease). 3. Must have expert molecular biology skills including cloning, PCR, and RNA quantitation. 4. Must have experience/career emphasis on mouse models of human disease. 5. Must have experience/career emphasis on mouse physiology. 6. Must have experience with transgenic and/or gene-targeted mouse models. 7. Prefer candidates with experience with mouse models of atherosclerosis and/or diabetes. 8. Prefer experience in vascular biology and immunohistochemistry. 9. Prefer experience with gene expression and/or proteomic micro arrays.
