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Vice President, Human Resources [MZA9939] Offers 20 years experience working in the following areas: employee relations, including the development and consistent application of polices along with the successful management of interpersonal issues; benefits, including plan design, administration, and communication; staffing and recruitment, including the analysis of functional requirements for the acquisition of new personnel, establishing minimum recruitment standards for each position, and designing recruiting alternatives; organizational development, including conducting strategic workforce planning, designing training programs that ensure employees perform their duties effectively, recommending resource optimization and succession strategies, and creating a corporate culture that identifies and rewards high performers; and compensation, including developing stock option/equity programs, classification and salary structures, performance management and salary administration plans, and incentives that link individual performance to organizational results. Very sharp and professional! Direct hire only.
President/Chief Operations Officer [NM4220] Impressive 15 plus years experience as a progressive, successful senior C-level operations and management executive. High energy leader who most recently led a turnaround program to a market growth position. Expertise in managing teams and building strategic partnerships. Held highest level positions in operations, sales, customer service, distribution, logistics, purchasing, internet technology and E-commerce. Recognized for having superior tactical vision and strategic aptitude with a history of advancing business culture, goals and profitability. Available for contract or direct hire opportunities.
Senior Medical Director [RD5268] MD, Internal Medicine with 14 years of pharmaceutical experience, 6 years of Phase I experience, including numerous first-in-human trials and multiple therapeutic areas. Phase II-III clinical trial design and conduct to include cardiovascular, gastrointestinal, endocrine, anti-infective, hematology, immunology (small molecule and protein therapeutics). Available for contract or direct hire.
Senior Director, Regulatory Affairs [LA7185] Offers 20 years experience in Biotechnology and 9 years experience in Regulatory Affairs. Proven successful track record facilitating regulatory approvals with US and international regulatory agencies. Major accomplishments included the development and optimization of protoplast transient expression assays and insect immunocytochemistry which played an important role in the success of the project. Direct hire only.
Regional Director, Clinical Operations [SVT6916] PhD in Neuroscience, with 12 plus years experience in the Clinical Research industry in both Clinical Research Organization and Pharmaceutical sectors, almost 9 years of which consist of Project Management experience. Possesses proven Global and International Project Management skills enabling the effective management of the entire clinical trial process. Experience in managing global clinical teams and CROs, integrating different cultures and nationalities into strong, well-bonded study groups. Able to assess and subsequently bring together the focus of key team members to ensure on time, effective and efficient delivery of a clinical trial. Ongoing tracking of financial/budgetary issues and detailed involvement in client, investigator and proposal meetings. Line Management and mentoring experience. Strong team player with excellent communication and proven leadership skills. Highly self-motivated aiding the formation of strong professional working relationships. Available for contract or direct hire.
Director, Clinical Development [RBR6081] DVM., PhD, offering in-depth experience in project management, clinical operations, medical affairs , business development, due-diligence, in-licensing, trial supply management and CRO management. Broad knowledge and skills in early and late clinical development (Phase 0-IIIb), managing hundreds of Phase 1-IV clinical trials in oncology, auto-immune diseases and a few other major therapeutic areas world-wide. Experience in preparing global clinical development strategy and product development plans for several anticancer drugs, and managed 39 company sponsored Phase I-IIIB protocols enrolling 46,000 cancer patients. Provided medical expertise and training to Medical Science Liaisons (MSLs) and coordinated their marketing/scientific activities. Has a proven track record of building high performance teams with passion for out-execution through proactive, consistent and entrepreneurial mindsets. Available for contract or direct hire.
Associate Director, Clinical Operations and Medical Affairs [LMA8177] Registered nurse with over 17 years of clinical research industry experience including clinical operations and project management, clinical research site evaluation and site selection, clinical trial monitoring and GCP quality assurance auditing. Strong background in SOP development, providing ICH-GCP training, process assessment and improvement. Diverse therapeutic area experience including infectious disease, oncology, vaccine research, immune deficiencies, pulmonary, gastrointestinal, endocrinology, wound care and cardiovascular disease management. Available contract or direct hire.
Associate Director, Clinical Research [TW1318] RN with 17 years of international clinical drug development experience; clinical program strategy and implementation, Phase I-IV clinical trial management, monitoring, educational program development and GCP quality assurance. Experience includes Critical Care Nurse, Surgical-Trauma ICU, Clinical Nurse I, Medical-Surgical Intermediate Care Unit, and Clinical Nurse II, Post-Anesthesia Care Unit. Therapeutic areas of expertise are: Central Nervous System, Respiratory, Anesthesia, Allergy, Asthma and Surgical. Available for contract or direct hire.
Associate Medical Director [KD8689] MD, Internal Medicine offering 16 plus years versatile experience in medicine, and 9 plus years of clinical research experience. Certified General Practitioner/Family Physician and Certified Physician in Occupational Diseases. Therapeutic areas of expertise include Internal Medicine, COPD, Pain Management and Diabetes. Available for direct hire only.
Clinical Senior Project Manager [RMS9962] MD who offers 9 plus years experience in clinical research and drug safety with therapeutic areas of expertise in oncology, vaccine, cardiology, ophthalmology, endocrine/metabolic and HIV/AIDS. Experience in project management, safety surveillance, global regulations and submissions to the FDA and EMEA, interpretation and analysis of medical/safety data, clinical synopsis and protocol development, preparation of clinical and safety sections of clinical safety reports, PSURs, investigator’s brochures, filing INDs and NDAs, management of project budgets, timelines, and milestones. Coordinated other functional group services such as Quality Assurance, Regulatory Affairs, Clinical Operations, Data Management, and Biostatistics. Available for contract or direct hire opportunities.
Manager, Clinical Trials Operations [NLB6247] Offers 17 years experience in project management, including 11 years in drug development and 6 years in environmental regulation. Experience includes Phase I, II, III, and IV of clinical trials, multiple therapeutic areas, with a specialty in oncology (solid tumors in breast, ovary, and prostate; leukemia, multiple myeloma, and sarcomas) as well as CNS, cardiovascular, infectious diseases, respiratory, genitourinary, and gastrointestinal Experience directing international studies, primarily working in Canada and Western Europe. Available for contract or direct hire.
Manager, Clinical Operations [KKC4046] MD, offers 10 years experience in medical research and family medicine with extensive expertise in gathering and analyzing medical data, 6 years experience in Drug Safety, Pharmacovigilance and FDA Regulatory Affairs. Experience as an instructor for physicians in the treatment of HIV/AIDS, Opportunistic Infections. Therapeutic areas of expertise are HIV, Infectious Diseases, Oncology, Substance Abuse, Endocrinology, Immunology and Rheumatology. Available for direct hire only.
Research Associate [AM2195] ACRP Certified Clinical Research Associate, with 7 years clinical research experience, including 5 years as a clinical research monitor and 2 years as an oncology clinical research coordinator; knowledgeable in Good Clinical Practices (GCP), FDA and ICH Regulations. Independently coordinate and perform activities at multiple external investigative sites in the evaluation, initiation, monitoring and closeout of clinical trials. Therapeutic areas of expertise include CNS: Parkinson’s disease, ADHD-adult and pediatrics, Anxiety, Depression, Diabetic and Multiple Sclerosis Central Neuropathic Pain, Cardiology: Hypertension, Hypercholesterolemia, and Sedation. Oncology, non-small cell Lung Cancer. Available for contract or direct hire.
Clinical Research Associate [LME2662] Registered Nurse with 20 plus years experience in providing direct patient care in Out-Patient Psychiatry, Home Infusion Therapy, Internal Medicine, Family Medicine, and Urgent Care Clinics including assisting MD’s medications, patient assessments, and extensive patient/family teaching. Six years experience in HMO Quality Assurance, Quality Management, NCQA and HEDIS and 6 years as a Clinical Research In-House CRA/Study Coordinator. Experienced in Phase II and IV adult Oncology Trials including lung, breast, and prostate cancer and related pain relief along with Cardiology and Fracture Prevention Trials. Available for contract or direct hire.
Clinical Data Manager [GM7987] 5 plus years working in the Pharmaceutical industry offering knowledge and experience in the areas of database planning (electronic data capture), DM resourcing and budgets, and providing solid Data Management expertise. Responsibilities included liaising with the Sponsor and third party vendors, of the following service lines; Safety Surveillance & Reporting, Clinical Monitoring/Site Management, Bio-statistics and Medical Writing, as well as, ensuring compliance with the Standard Operating Procedures (SOPs) and Good Clinical Practices (GCP). Therapeutic experience includes phases I - IV, in the therapeutic areas of Cardiovascular, Respiratory, Infectious Disease, Oncology, and Bone Disease. Available for contract or direct hire.
Assistant Clinical Data Manager/Data Team Lead [BWD6721] Offers 8 years experience in the clinical data management field. Experienced with FDA electronic submissions, editing and proofing of Protocols, CSR’s and Regulatory reports for publishing in Core Dossier. Experienced working with documentum, importing, exporting, scanning, merging and creating new files. Experienced with ICD-9/CPT, Who Art and MeDDra coding. Exposed to ClinTrace, ClinTrial, Relsys, and Oracle Clinical and SQL Query. Coded of SAE/AE events for the safety database. Excellent team leadership and time management skills. Therapeutic areas of experience include Cardiovascular, Oncology (Breast and Lung), and Infectious Diseases. Available for contract or direct hire.
Clinical Data Management Specialist [IAB7973] Offers 7 plus years experience in pharmaceutical data management, staff supervision, training and project management. Experience with 3 large studies that were global and ranged from Phase III-IV with indications of Asthma, Diabetes, Multiple Sclerosis and Schizophrenia. Therapeutic areas include Oncology, Cardiovascular, Respiratory System, Endocrine/Metabolic and Central Nervous System, Cardiovascular and Infectious Disease. Available for contract or direct hire.
Research Scientist [CR5883] PhD in Biochemistry, MS in Biochemistry and a BA in Biology. Offers 20 years experience performing as an Analytical Chemist/Biochemist with a strong technical background and excellent problem solving skills. Pharmaceutical experience is with troubleshooting, developing, validating, and transferring analytical chemistry and biochemistry assays for sterile pharmaceutical small molecule, protein, and vaccine products in a GMP environment. Experience in analytical chemistry is with HPLC, GC, TLC, KF moisture, Fluorometry, Gel Electrophoresis, SFC and CZE. Available for contract or direct hire.
Scientist [TMH3037] PhD with 9 years pharmaceutical industry experience and 17 years healthcare industry experience involving strategical thinking, effective communication, planning and data tracking skills. Great understanding of the drug development process from pre-clinical research through clinical trial research phases I –IV. Knowledgeable of medical and clinical trials terminology. Therapeutic areas of expertise include Cardiovascular, Epidemiology, Anesthesia and Oncology. Technical skills include Microsoft Office (Microsoft Word, Excel, Access, Power point and Outlook), familiar with SPSS software (statistical and data management software for researchers), Atlas ti software (A qualitative computer generated software program used to qualitatively analyze, interpret, sort and administer textual, graphical as well as audio and video data); and CATI software (computer assisted telephone interviewing) PharmaVigilant - Inspire Electronic Data Capture (EDC); Lotus Notes databases, graphing; Sorting by randomization techniques. Available for contract or direct hire.
Associate Scientist II [DW6990] PhD in Biochemistry with highest honors. Offers experience as a Pharmaceutical scientist leading multi-disciplinary drug discovery project teams. Exceptional organizational skills which can provide scientific and project leadership in the pharmaceutical, CRO and biotech environments. Developed novel biochemical approaches for the discovery of hypolipidemic agents targeting distinct steps in the sterol biosynthetic pathway. Established the human Caco-2 cell system to investigate the transport and mechanism of action of ileal bile acid uptake inhibitors. Therapeutic areas of expertise include Cardiovascular, Pulmonary, Renal and Diabetes. Available for contract or direct hire.
Scientist II [RH2984] Offers 8 plus years experience as a Scientist, Associate Scientist II and as an Associate Biochemist. Technical expertise includes multiple robotic platforms such as Beckman Coulter BioMek FX, Genetix ClonePixFL, and Phynexus MEA1000 Purification System. Technical expertise in multiple screening formats such as ELISA, FMAT, CelTRF, Western Blot, BacMam transductions. Broad knowledge and experience in assay development, method transfer, troubleshooting and validation and maintaining laboratory notebooks and analyzing data to assist with preparing scientific reports. Available for contract or direct hire.
Medical Science Liaison [JHB4942] PharmD offering 25 years of pharmaceutical experience in Director and Manager roles across multiple disciplines in Commercial Operations and Medical Affairs departments such as Medical Liaison, Medical Information, Medical Publications, New Product Planning, Competitor and Regulatory Intelligence. Direct hire only.
Biologist/Scientist [KAB1808] PhD in Microbiology offering 8 years experience in the research field. Scientific duties included designing diverse research projects, maintaining and executing the projects and directing staff. Responsibilities included preparing internal/external reports and presentations, writing standard operating procedures, performing bench work and serving as a molecular biology expert. Technical skills include DNA/RNA isolation/purification/quantization, DNA sequencing, DNA foot printing (micrococcal nuclease, hydroxyl, radical), DNA topology (super coiling) analysis by PAGE, EMSA, denaturing gradient gel electrophoresis (DGGE0, 2-D gel electrophoresis, gene expression analysis using microarrays (Affymetrix/2-dye platforms) and more. Available for contract or direct hire.
Molecular Biologist [RSM5095] Offers 8 years experience in RNA and DNA preparation; Restriction digests; Gel electrophoresis; Vector preparation; Subcloning; electroporation; Cloning strategies and implementation; Primer design; PCR; RT-PCR; siRNA; DNA sequencing and analysis; Vector NTI(AlignX, ContigExpress); Microsoft Word, Excel, Outlook. Experience in designing and developing molecular diagnostic Real-Time PCR assays using ABI 7900HT and Cepheid SmartCycler; Produced control materials for these assays; Assisted in preparation of regulatory documents pertaining to FDA approval and manufacture of commercial products. Available for contract or direct hire.
Quantitative Data Analyst (Research Associate I) [GA5307] Offers 30 years experience in systems engineering, data processing and data analysis with government agencies and pharmaceutical companies. 15 years experience in CRO and Pharmaceutical industry and 6 plus years direct experience in the support of IND and NDA applications. Experience as a data manager of clinical and non clinical data, statistical programmer producing tables/graphs/reports for IND and NDA applications. Experienced working in production and research environments processing toxicological, carcinogenic, pathological, and pharmaceutical data for numerous investigational and research activities. Systems experience spans numerous computing platforms, operating systems and application software, especially in the areas of data processing and statistical analysis. Available for contract or direct hire.
Data Analyst, Epidemiology Programmer/Analyst [LRZ9398] PhD in Applied Mathematics, 3 years working experience with statistical analysis, predictive modeling, data mining, experimental design and optimization. 3 years experience in data manipulation, data cleaning and exploratory data analysis with large-scale datasets. Hands-on experience in Time Series, Logistic Regression, Linear Regression, Bayesian Anlaysis, Clustering, Decision Trees (CART and CHAID), Neural Network, SVM, Karkov Modeling and Survival Analysis. Proficient with C. SQL, SPSS, Clementine, SAS (SAS Certificated Base Programmer) and familiar with Windows and UUNIX environments. Available for contract or direct hire.
Data Programmer II [SDM1377] BA in Psychology with solid work history. Offers 13 years computer programming experience and has certifications in Database Programming, Visual Basic 6 Programming. Promoted through increasingly challenging positions with an award-winning, privately held plug-in design software company specializing in Adobe Photoshop application programming interfaces. Products include Snap Art, BlowUp, Exposure, Image Doctor, Eye Candy, Splat and Xenofex. Recognized as a resourceful contributor and acknowledged with increased development responsibilities. Available for contract or direct hire.
Programmer Analyst, Clinical Data Programming/Analyst, Clinical Data Programming [LH0695] Offers 6 years of progressive programming experience in the area of population-based, age-related diseases in clinical research and more than 5 years experience of EMC. Technical skills include software programming in SAS/Stat, SAS/Macro, and SAS/Graph, FORTRAN, MATLAB, CRG, GoM, Visual Basic and ABEL. Fluent in Chinese – Mandarin. Available for contract or direct hire.
Quality Assurance Auditor [DNW9724] MS Degree in Agricultural Education offering 11 plus years experience in complete physical and chemical testing, GLP and GMP procedures, compliance enforcer and reviewer of analytical data according to protocols and the FDA, in-process auditing, and analytical chemistry auditor of contract pharmaceuticals. Broad knowledge of auditing, analyzing and research of field trial notebooks according to protocol for pesticide testing and Federal Insecticide Fungicide and Rodenticide Act. Available for contract or direct hire.
Senior Quality Assurance Associate [CKL2428] Offers 6 plus years experience inBiotechnology/ Pharmaceutical and Clinical Research Development. Expert in multitasking, organizing clinical study trials from Phase I to Phase IV. Facilitate development of standard processes for administration and management of documentation (e.g. procedures, policies) for Medical Affairs /Clinical (MA/C). Provide quality control review for non-technical basis for MA/C documentation (e.g. reports, procedures, protocols, and Investigator Brochures (IB’s), version control. Plan and implement the training requirements including new and revised SOP training, personnel development and qualifications and GCP or GLP training as defined by area management and Performance Development (PD). Liaison working with R&D such as study directors and medical directors to administer documents from key opinion leaders, experts, investigators, clinical research organizations (CROs), central laboratories, supply distribution supporting the Medical Affairs/Clinical department studies and interactions. Available for contract or direct hire.
For more information on these candidates, contact us now at pharma@qual-exec.com or by phone at 919.463.5311 or 1.866.933.1802.
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