Posted August 24, 2010 Abbott
Abbott Park, IL
Pathologist DVM
At Abbott, every day is filled with new discoveries and leading-edge innovation. Our professionals are passionate about life, health care and their contributions. With almost $26 billion in sales in more than 130 countries, we’re not just poised to enhance the health of the world—we’re positioned to make it happen.
The Preclinical Safety organization at Abbott is seeking a highly motivated board certified/eligible pathologist to join our team.
Job Responsibilities:
Toxicity Studies—In cooperation with the Toxicology Department (D-468) the pathologist designs, directs, conducts, and evaluates studies to determine the potential toxicity of experimental compounds and devices in different species of animals. This involves interpretation of data in the field of pathology, i.e., necropsy, histopathology, clinical pathology and electronic microscopy. Responsible for implementing and maintaining the effectiveness of the quality system.
The pathologist combines the anatomic pathology data with the obtained clinical pathology data and finalizes the Drug Safety Evaluation report (pertaining to the Pathology Department) with the Toxicology report.
Consulting and collaborating with scientific staff of other departments and divisions of the company other than Department D-468. Designs and interprets the studies as the needs of those divisions arise.
Comments:
Supervisory responsibilities: The pathologist is responsible for the direction of assigned technical and professional e.g., plans and schedules activities for supervised functions; provides scientific and technical leadership to subordinates; reviews and evaluates work from a business and scientific point of view; creates a working environment that motivates people; and participates in job performance appraisals and compensation recommendations.
Accountability/Scope:
Accountability: Position is accountable for the INTERPRETATION and EVALUATION of biological data in biological and pharmaceutical R&D, biological control, toxicology, general consultation, and solution of problems in these areas. The accuracy of the interpretations and evaluations is of far reaching importance relative to the product clearance by governmental agencies, possible liability in cases of inaccuracies, etc.
Scope: Pathologists are essentially independent in the discharge of their major duties and responsibilities.
Problem Solving:
Technical and scientific problems are diversified and non-repetitive, such as interpretation and evaluation of biological data from toxicology, pharmaceutical and biological R&D, biological control and consultation problems. Problems require considerable cooperation with other departments and other Abbott divisions.
Basic Qualifications:
This job requires professional training as a D.V.M. (or equivalent) plus some post-graduate training in pathology, preferably to the Ph.D. degree and board certification in anatomic pathology (or board-eligible); familiarity with related fields (i.e., toxicology, pharmacology, and clinical research) is also necessary; seasoned experience in biological research and the ability to work effectively with other people; a knowledge of the department and the company and its organization, and should be recognized professionally in the scientific field.
Preferred Qualifications:
Candidates with ACVP (or equivalent) board certification in anatomic pathology and a Ph.D. are strongly preferred.
0–2 years experience in toxicologic pathology at a pharmaceutical company or CRO
Ph.D. or postdoc training with a proven scientific record is preferred
Abbott offers a comprehensive salary and benefit package. Qualified candidates may apply by posting their resume to www.abbott.com/careers. Reference number: 79530BR. Abbott provides a “smoke-free” work environment.
Posted August 24, 2010 Integrated Laboratory Systems, Inc.
Research Triangle Park, NC
Toxicology Pathologist
ILS is looking to fill one Toxicology Pathologist position. The duties of this position Include (but are not limited to): Evaluate subchronic and chronic toxicity/carcinogenicity studies in rats and mice and peer review pathology data and reports. Organize, coordinate, and conduct National Toxicology Program (NTP) peer review pathology working groups (PWG) and prepare PWG summary reports. Serve as study pathologist on commercial and government research studies, providing gross and histopathological evaluations and preparing pathology reports. Perform quality assessment of pathology specimens. Work in multidisciplinary teams. Interact with clients. Work in a team environment with a professional and positive attitude and perform other duties as needed. The education requirement for this position is D.V.M degree from an accredited college of veterinary medicine or equivalent, however a Ph.D in relevant field is preferred. The position requires a Board Certified, Veterinary Anatomic Pathology ( ACVP). Please visit ILS-inc.com for more information and to apply.
Posted July 23, 2010 SAIC-Frederick, Inc.
Frederick, MD
Principal Scientist—Molecular Toxicology
The NCI’s Developmental Therapeutics Program’s (DTP) mission is the discovery, development and characterization of new anticancer drugs and their molecular targets. The position will provide senior scientific leadership for SAIC-Frederick’s laboratory support of the Toxicology & Pharmacology Branch, DTP, Division of Cancer Treatment & Diagnosis. The Investigative and In Vitro Toxicology Sections investigate toxicologic mechanisms and evaluate molecular toxicology, cellular toxicology and early ADME properties of experimental and investigational anticancer agents, using best available technologies, in vitro systems or newly developed ones as needed. Responsibilities include directing and managing the laboratory program to maximize SAIC-Frederick’s contributions to the success of the Branch’s mission within DTP and within the NCI’s NExT Program during interactions with project teams and other groups; serving as the daily point of scientific/technical contact for government officials of the Branch and the larger DTP organization; programming new laboratory support of the Branch’s molecular toxicology effort; leading the scientific and technical staff of the laboratory, including recruitment of open positions, to assure successful completion of projects and technical tasks; and managing lab operations and resources within SAIC-Frederick’s corporate organization, including assisting the Director of the Laboratory of Human Toxicology and Pharmacology in program management and coordination.
Required
Doctoral degree (e.g., D.V.M., Ph.D., D.Sc., M.D.) from an accredited college or university appropriate to toxicology, drug safety and/or pharmacology. Foreign educated candidates who have completed part or all of their education outside of the United States must have their foreign education evaluated by an SAIC-approved accrediting organization to assure that it has met the equivalency of the qualifications of degree work in the United States. Must have at least eight years of postgraduate experience in the investigation and assessment of molecular targeted drug effects and modulation of protein and/or gene function, using advanced biochemical, biophysical, in silico, molecular biology, and other analytical techniques. Must have at least five years of experience in molecular toxicology analysis and data interpretation, and evidence of successful laboratory programming and implementation of these activities that have made a positive impact upon a developmental therapeutics program. Must have at least three years of experience managing a laboratory and supervising both scientific and technical staff. Must possess the ability to convert toxicological questions into laboratory-based, experimental investigations of molecular mechanisms, and provide evidence of peer recognition of this ability (first authored publications in peer reviewed journals, group leadership experience in industry, platform presentations at national meetings, etc). This position is subject to obtaining a Public Trust Clearance.
Desirable
Ability to develop and implement new research plans for complex projects involving molecular biology, targeted therapeutics and new and/or innovative assays of molecular drug effects (both on- and off-target), and foresee the technical achievements that will be required to provide definitive answers to key toxicology questions. Ability to translate laboratory-based results into the toxicology setting, including integration with animal modeling and clinical toxicology findings. Ability to judge emergent technologies in the private sector and provide rationale for decisions about outsourcing molecular toxicology tasks versus developing in-house capability. Ability to clearly present and articulate toxicological findings and principles to project teams and more general audiences using verbal and written communication. Demonstrated leadership ability and interest in developmental therapeutics for cancer. Nationally recognized leadership in molecular toxicology.
Excellent compensation package accompanies our position.
For immediate consideration, please apply on-line for position #178586 at www.saic-frederick.com.
Posted July 20, 2010 Human Genome Sciences
Rockville, MD
Toxicologist
Summary
Human Genome Sciences (HGS) is a biopharmaceutical company with approximately 800 employees and world-class R&D and manufacturing facilities based in Rockville, MD. We have three promising products in late-stage development—one, raxibacumab, already commercialized with sales to the U.S, Government and two products moving toward commercialization, BENLYSTA™ (formerly LymphoStat-B®) and ZALBIN™ (formerly Albuferon®). We are developing both of these products in collaboration with world leaders in the pharmaceutical industry.
At HGS, people are the key to our success. We share a passion for scientific and business innovation, creating unique opportunities to contribute to the commercialization phase of our products. At HGS, you will have opportunities to learn and grow; interacting with talent of the highest caliber, and you will be supported by a culture committed to employee and leadership development. We offer a competitive salary and benefits package. HGS is an Equal Opportunity Employer EOE/AA M/F/D/V
Description
The Department of Pharmacology, PK & Toxicology provides scientific leadership and plays an active role in the process of drug development from the discovery period through marketed products. We are seeking an energetic scientist to support nonclinical drug development. This role will involve working in a collaborative team environment as part of the comprehensive nonclinical safety assessment of new therapeutics by providing toxicology representation to small and large molecule programs.
The successful candidate will provide scientific leadership and play an
active role in the design, monitoring and execution of various GLP and non-GLP studies required to enable filing of IND, BLA/NDA.
Working in a collaborative team environment, the toxicologist leads the safety assessment of various novel therapeutic molecules by comprehensive investigations of toxicologic activity.
Will work closely with various divisions within and outside of the department and ensures seamless flow of information.
The successful candidate will design and supervise in vitro and in vivo toxicology studies to support the goals of project teams, work closely with Study Directors, Pathologists and Pharmacokineticists to deliver high quality GLP and non-GLP in vivo study reports and, as needed.
Will represent HGS in meetings with regulatory authorities and at outside conferences.
Responsibilities include interdisciplinary project team membership, preparation, and review of regulatory documentation, study reports and manuscripts, participation in toxicology and pharmacology initiatives, and other active cross-functional collaborations.
Level of the position will be dependent on the experience of the candidate.
Requirements
Applicants should have a Ph.D. and post-doctorate or equivalent experience in toxicology or a relevant field, with at least 5–8 years of relevant experience in the pharmaceutical/biotechnology industry related to toxicology.
Board certification in toxicology is also desirable.
Demonstrated regulatory toxicology experience on multiple projects
Experience with cross-functional teams and capability to build productive
cross-functional collaborations both within and external to HGS are desired.
Candidates with experience in both biologic and small molecules drug development are desirable.
Experience in supporting various therapeutic areas and not specific to one area is preferred.
Qualified candidates must demonstrate strong decision-making, complex problem-solving, critical data analysis and interpretation, excellent written and verbal communication skills.
Please visit the HGS Web site for further information on our company and to apply on-line for this position.
Posted July 20, 2010 Human Genome Sciences
Rockville, MD
Veterinary Pathologist
Summary
Human Genome Sciences (HGS) is a biopharmaceutical company with approximately 800 employees and world-class R&D and manufacturing facilities based in Rockville, MD. We have three promising products in late-stage development—one, raxibacumab, already commercialized with sales to the U.S., Government and two products moving toward commercialization, BENLYSTA™ (formerly LymphoStat-B®) and ZALBIN™ (formerly Albuferon®). We are developing both of these products in collaboration with world leaders in the pharmaceutical industry.
At HGS, people are the key to our success. We share a passion for scientific and business innovation, creating unique opportunities to contribute to the commercialization phase of our products. At HGS, you will have opportunities to learn and grow; interacting with talent of the highest caliber, and you will be supported by a culture committed to employee and leadership development. We offer a competitive salary and benefits package. HGS is an Equal Opportunity Employer EOE/AA M/F/D/V
Description
We are looking for an enthusiastic and energetic discovery oriented Board Certified Veterinary Pathologist, to actively collaborate, manage and execute various “pathology” related activities within the Department of Pharmacology, PK & Toxicology. The Department provides scientific leadership and plays an active role in the process of drug development from the discovery period through marketed products.
The successful candidate will actively participate in the discovery/characterization of novel drug targets, preclinical development and safety assessment of our novel therapeutic molecules.
The incumbent will interact with innovative scientists of multiple specialties on projects directed at elucidating disease/target mechanisms, characterize the efficacy and safety in various nonclinical species as part of early drug development.
Pathologist conducts histopathologic, immunohistochemical and morphometric evaluations to support a wide variety of therapeutic areas including inflammation, immune-mediated diseases, anti-infectives and oncology.
This individual will be a senior member of Department of Pharmacology, PK & Toxicology and would collaborate extensively within the Department and with multiple other departments, such as Clinical Immunology, Oncology, Clinical Research and Regulatory Affairs.
In addition, this position would entail managing a group of 4–6 RAs and is responsible for the “pathology” work on various nonclinical and clinical projects.
The individual will work closely with toxicologists providing expert analysis and interpretation of pathology findings from toxicology studies.
We are looking for a discovery oriented research pathologist who is an effective communicator, an enthusiastic collaborator, and loves to work in a team-based environment.
Must have strong technical and writing skills and a desire to publish in peer reviewed journals and author relevant sections of regulatory documents.
Provide coaching, development, and performance management to direct reports.
Requirements
DVM or equivalent, and/or Ph.D. in Veterinary Pathology
Diplomate of ACVP required
A minimum of 5–8 years of experience in early drug development conducting toxicological pathology
Demonstrated interests and involvement in “research pathology” preferred
Track record of publications in peer reviewed journals
Excellent communication (both written and verbal) and organization skills and the ability to write accurate, concise pathology reports and phenotype project summaries
Ability to prepare technical reports, author regulatory documents and deliver presentations
Ability to function autonomously in a multi-disciplinary team environment
Please visit the HGS Web site for further information on our company and to apply on-line for this position.
Posted July 13, 2010 Roche
Basle, Switzerland
Toxicology Project Leader
Who We Are
At Roche, 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing—and is seeking people who have the same goals for themselves.
The headquarters in Basel is one of Roche’s largest sites. It is home to the Corporate Executive Committee, the Pharmaceuticals and Diagnostics Divisions and the global business functions. Roche Basel also covers the entire business chain from research, development and production through to marketing. Over 8,000 people from more than 60 countries work at the site.
The Position
The successful candidate will be a key contributor to the safety selection and timely development of potential new medicines through close interactions with discovery therapeutic areas, and affiliated non-clinical, clinical development and regulatory functions.
The candidate will steer and coordinate toxicological/non-clinical safety evaluations of development compounds within Roche, and externally with contract laboratories, consultants, and development partners.
He/she will represent toxicology in international project teams, contribute to internal and regulatory documents (IBs, CTAs, INDs, NDAs etc.) and participate in internal review board meetings as well as in meetings with regulatory authorities.
The position is focused on projects in advanced stages of clinical development.
The position holder will be located in Basle, Switzerland. Flexibility regarding international travel is expected.
Who You Are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point.
Requirements include a DVM, Ph.D. or equivalent and advanced experience in all areas of toxicology.
Ideal candidates have a minimum of five years experience as a project toxicologist in drug development, with a demonstrated ability to manage multiple scientific projects and make sound scientific interpretations and assessments. A good publication record and/or activities in international gremia are an asset.
Candidates must have a proficient knowledge of general toxicology and related disciplines and proficient understanding of regulatory toxicology and international guidelines.
Candidates must be capable in the design, conduct, interpretation, and reporting of regulatory toxicology studies, be able to address and resolve toxicological issues arising in drug development programs, appropriately communicate and adequately assess the relevance of any toxicological findings to human safety.
Excellent communication and presentation capabilities in English are critical for successful application.
Ability to prioritize and capability to deal with high expectations in a competitive environment, excellent interpersonal skills, collaborative problem solving in a matrix environment, project management and team interactions are a must in order to be successful in this role.
The next step is yours. To apply on-line today or learn about other exciting positions, please visit www.careers.roche.ch. Job ID: #21623
Posted July 7, 2010 Bristol-Myers Squibb
Wallingford, CT
Director, Toxicology
Management, provide support and guidance to doctoral and technical staff as well as scientific and professional mentorship, performance review, resolution of operational issues. Discovery Working Group, DWG, representation, develop early safety assessment, ensure appropriate toxicology studies and liability screens are performed to support nomination of drug candidates for further development, prepare integrated summaries and reports, as required. Aslo, provide functional area oversight and review of activities, communications, presentation, and documents from direct reports that also represent Discovery Toxicology on DWGs. Functional, identify and resolve issues primarily but not limited to toxicity impacting therapeutic targets and potential drug candidates within a matrix model, such as pharmacology, chemistry, DMPK, pharmaceutics, Drug Safety Evaluation. Represent transition of potential drug candidates into Development. Leadership, demonstrate innovation, collaboration, and sound decision making.
Education preferred is a Ph.D. in Toxicology, D.V.M. or equivalent with 12 years of experience. This position will require broad based knowledge of biochemical and mechanistic toxicology and strong understanding of pharmacology, pharmacokinetics, and biotransformtion. The candidate should possess expertise in, in vivo toxicology study design and conduct, and be knowledgeable regrding in vitro toxicity models, genetic toxicology, evaluation of target based toxicity, and safety pharmacology. Borad certification in Toxicology or Pathology is desirabe but not essential. At least 8 years experience in pharmaceutical discovery and development is required. Experience in discovery or development of therapeutic candidates for CNS related disease or virology is also desirable. A track record of strong leadership and management of doctoral scientific and technical staff, collaboration, and communication skills are esential for this position.
BMS is an equal employment opportunity employer.
Please visit bms.com to apply to role and refer to position #1002235.
Posted July 6, 2010 SNBL USA, Ltd.
Everett, WA
Director, Pathology Services
Are you looking for a challenging opportunity where your senior level expertise will have a significant impact on the quality of services provided by the Pathology Department? Do you thrive in a fast paced environment where your ability to share your knowledge & motivate employees will directly contribute to success? We are looking for a unique and highly skilled Director, Pathology Services to proactively manage our Pathology Services area which will include oversight of approx. 25 employees and responsibility for ensuring the quality and integrity of Pathology Services offered by SNBL USA.
SNBL USA is a scientific contract research organization providing preclinical research services to biotech and pharmaceutical clients throughout the world. We are a GLP compliant facility offering study programs ranging from general toxicology to customized study designs and disease models. Our specialized programs and services include developmental & reproductive toxicology, safety pharmacology, immunotoxicology, and carcinogenicity. SNBL USA strives to provide the highest quality research and science by encouraging an environment where our employees can generate their own personal success, one day at a time.
As a member of the leadership team, the Director, Pathology Services will be involved in activities including strategic planning, department goal setting, budgeting, and process improvement efforts with Lean Six Sigma. The Director, Pathology Services will have responsibility for representing SNBL USA and interfacing successfully with clients, regulatory agencies and cross functionally within the organization. This is a hands-on position which requires day to day interaction with Pathology team members to share technical expertise, coach performance and drive accountability and results within the department.
The ideal candidate will have an extensive background in a GLP compliant Pathology laboratory. A minimum 10 years in a GLP pathology environment is required along with a DVM and PhD in Pathology or related field. Diplomate, ACVP highly desired. Minimum 5 years at the Sr. Manager level within a biotech, pharmaceutical or preclinical facility is required. The ability to analyze and solve ongoing multifaceted issues, a strong ability to communicate with others and facilitate change will ensure success in this position.
This position is located in Everett, WA (20 miles north of downtown Seattle). Comprehensive benefits package and relocation assistance is included.
Apply for this position by submitting your cover letter, CV, and salary requirements to: hr@snblusa.com.
Please visit us on-line at www.snblusa.com for more information.
SNBL USA is proud to be an Equal Opportunity and Drug Free Employer.
Posted June 21, 2010 Eisai Research Institute
Andover, MA
Sr. Research Investigator
Eisai is Japan’s third largest pharmaceutical company, ranking in the top 25 worldwide. Eisai in Andover, MA is the drug discovery center for product creation in the United States with an emphasis on finding treatments for immune disorders and cancers.
We are seeking to fill the new post of Sr. Research Investigator in the Drug Safety group of our Biopharmaceutical Assessments business unit. This position will be the Histopathology expert for Eisai’s operations in the US. The successful candidate will collaborate with Preclinical and Clinical researchers, Regulatory, Eisai Global Safety personnel, and interact with governmental Regulatory agencies to plan, implement, and interpret safety studies for early projects, candidate drugs under development, and marketed products.
Primary Responsibilities Include:
Principal investigator of histopathology in exploratory, pharmacology and/or toxicology studies:
Study the nature, cause, and development of diseases and the structural and functional changes caused by them.
Conduct/oversee postmortem phases of toxicology/pharmacology studies.
Address any inquiries regarding animal toxicity from regulatory agency.
Collaborate with Discovery, Development and Clinical groups to investigate new compounds for toxicity both in U.S. and Japan.
Research Project Team Representative:
Evaluate and provide advice to project teams regarding the interpretation of physiological and histopathological data from pharmacology experiments.
Plan and execute nonclinical safety evaluations in support of ongoing projects.
Design protocols, monitor and review studies conducted at contract research organizations.
Review clinical protocols and provide necessary information to select dose levels in clinical trials.
Prepare nonclinical safety assessment portion of regulatory submissions including study reports.
Work with Life Science personnel and biologists to establish in vivo disease models.
Participate and contribute the Eisai’s Global DS meetings.
Qualifications/Skills:
D.V.M or equivalent degree
Board certification and/or Ph.D. desirable
More than 3 years of experience in pharmaceutical companies
More than 3 years of experience in toxicologic pathology
Experience in toxicology, i.e. conduct and summarize toxicology studies on new drug substances, is desirable
Excellent communication skils and ability to work collaboratively
Eisai Research Institute conducts background checks and pre-employment physicals.
We are an equal opportunity employer M/F/D/V.
Posted June 16, 2010 Novartis Global HQ
Basel, Switzerland
Molecular Pathologist and Lab/Group Leader Localization
You will report to the Global Head of Molecular Pathology and be responsible for histopathology of an integrative approach of the mechanisms of toxic lesions in tissues by connecting molecular events and their morphological consequences.
Location and Company:
Basel, Switzerland (Novartis Global HQ—We will support relocation and work permits) Novartis is a great company to work for—25 major regulatory approvals in 2009 with a further 135 projects in the pipeline as of end Q1 2010. Our Novartis Institutes for BioMedical Research is fundamental to this success with research focussed on signalling pathways rather than individual genes and proteins. This role is within the Preclinical Safety group of the Translational Sciences unit—driving innovation in the selection and rapid development of next generation safe effective therapies.
Molecular Pathologist:
Contribute to interpretation of histological material generated in studies addressing mechanisms of toxicity using standard and molecular staining
Interpret localization data (immunohistochemistry and in situ hybridization) for cross-tissue/species distribution of molecular entities (proteins, mRNA, miRNA, functional probes, etc.)
Contribute to gene expression analysis LAB/GROUP LEADER (3+ associates)
Coordinate lab activities including design and supervision of ICH, ISH, & LCM activities with high scientific and technical standards
Manage and develop associates and resource
Strategic development towards seizing new opportunities for the group
Major Accountabilities:
Design and supervise adequate localization activities aiming at precising the interpretation of gene expression profiles from tissue samples
Interpret results of localization activities including quantitative data from image analysis to extract implicit and novel information to characterize genes involved in physiological and/or pathological state following drug therapy
Prepare reports and contributions to integrated molecular pathology reports, phase-transition and registration documents
Contribute to a gene expression atlas by providing localization data for specific molecular entities
Exploit interactions between gene expression analysis—localization/LCM techniques and histopathology to support integrated molecular pathology
Independent research leading to fundamental insights in molecular pathology as a scientific discipline
Head a project by providing scientific input, designing in-life studies, analysing expression data, and prepare reports and contributions to phase-transition and registration documents
Develop scientific strategy within Molecular Pathology and Investigative Toxicology
Publish and present results widely at internal/external meetings
Influence phase transition of compounds/projects by providing decision-enabling interpretation of expression data
Job Requirements:
MD or DVM, board-certified pathologist or equivalent. Additional Ph.D. preferred, otherwise proven scientific research/publishing
Experience line manager of directs reports and lab management
Extensive operational knowledge of gene expression analysis from tissues
Proficient data interpretation techniques applicable to toxicology
Knowledge in toxicology or toxicologic pathology
Significant scientific experience in molecular pathology/molecular toxicology
Excellent data summarization and oral/written communication skills: fluent English, presenting complex data clearly and simply, defending data, influencing the study design decision process
Posted June 10, 2010 University of Illinois Urbana-Champaign, Department of Pathobiology
Champaign, IL
Faculty Position in Anatomic Pathology
The Department of Pathobiology at the University of Illinois Urbana-Champaign is expanding its program in anatomic pathology and is accepting applications for two full-time tenure track or clinical faculty positions at the rank of Assistant, Associate or Full Professor. The Department is looking for well rounded candidates to teach in the DVM professional curriculum, train residents and graduate students in pathology, contribute to the research mission of the College and/or participate in anatomic pathology service. Minimum qualifications include a DVM degree (or equivalent); highly competitive applicants will also possess a Ph.D. degree in veterinary pathology or allied discipline and diplomate status (or eligibility for certification) in the ACVP. A demonstrated commitment to excellence in instruction and a record of research achievement are also preferred. A competitive salary and startup funds will be provided.
Campus research facilities include the Beckman Institute for Advanced Science and Technology, the Roy J. Carver Biotechnology Center, the Institute for Genomic Biology, and the National Center for Supercomputing Applications. AAALAC-accredited animal care facilities, AAVLD accredited diagnostic laboratory, the GIS and Spatial Analysis Laboratory, and instrumen¬tation for flow cytometry, laser capture microscopy, confocal and electron microscopy are located within the Department of Pathobi¬ology. Urbana-Champaign, located 120 miles south of Chicago, offers a variety of cultural opportunities that showcase the area’s ethnically diverse population, superb public and private schools, quality public transportation, and a rapidly expanding community of high-tech businesses.
To ensure full consideration, applications must be received by September 1, 2010. However, applications will be accepted until all positions are filled. Apply on-line and include curriculum vitae, summary of research interests, and plans, and the names and contact information for three or more professional references. Applicants may be interviewed prior to the closing date however no hiring decisions will be made until after that date. The anticipated starting date will be on or about January 1, 2011.
The University of Illinois is an Affirmative Action/Equal Opportunity Employer.
Posted June 2, 2010 Johnson & Johnson Family of Companies
Raritan, NJ
Research Fellow
Position Description:
Johnson & Johnson Pharmaceutical Research & Development, a member of the Johnson & Johnson Family of Companies, is recruiting an experienced Veterinary Anatomic Pathologist, at the Research Fellow level to join the Tox/Path/LAM Team within Pre-Clinical Development. The successful candidate will work on a global basis to deliver scientific support to Drug Discovery, Development Projects and Investigative Problem solving Teams. Depending on experience, capabilities and interests, the successful candidate may take on leadership and management responsibilities.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. develops novel and innovative treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets for small and large molecules (Biologics) in Neuroscience, Oncology, Cardiovascular & Metabolism Disorders, Immunology and Infectious Diseases.
The successful candidate will support drug discovery and development by providing scientific input in the design and conduct of toxicology experiments that focus on characterizing the safety of novel therapeutic targets and/or understanding potential mode of action for toxicity in pre-clinical studies.
They will also review study protocols and make recommendations regarding the design of the clinical pathology and anatomic pathology portions of toxicology studies.
Additionally, they will conduct gross and microscopic examinations of animal tissues from toxicology and investigative studies, interpret and explore the significance of results for clinical pathology, organ weight, necropsy, and histopathology data. Present pathology data/results at Discovery and Development research project team meetings.
They will provide concise written pathology reports that accurately and completely reflects the data collected and the significance/impact on candidate drug development, drug registration and human safety. They will also provide investigative pathology leadership for drug discovery teams and identify and lead collaborative scientific efforts with internal, external, consortia and academic investigators.
Position Qualifications:
The successful candidate must have a D.V.M. and is board certified by American College of Veterinary Pathologists (ACVP) In addition, a PhD is strongly preferred. A solid scientific publication record, and a minimum of 7 years of experience in the field of toxicological pathology and experience in conducting GLP toxicology studies is desirable. Excellent communication, project management skills and recognized knowledge and expertise in the field of pathology is required.
To Apply:
As a valued team member, you’ll receive a competitive salary and great benefits including medical/dental, a 401(k), a pension plan and a comprehensive wellness program. If interested, please apply directly on-line at our Web site, www.careers.jnj.com, noting Req. Code 3828100518. The Johnson & Johnson Family of Companies has a strong commitment to diversity and welcomes applications for all individuals. EOE M/F/D/V
Posted May 28, 2010 Roche
Nutley, NJ
Veterinary Pathologist
Who we are…
At Roche, 79,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing—and is seeking people who have the same goals for themselves.
At our Roche Pharma Research site in Nutley, New Jersey, one of seven global Research Centers, our main focus will be on oncology, inflammation, virology and immune-mediated disorders, metabolic disorders and RNAi Therapeutics, and Metabolic. Within global Non-Clinical Safety, the Nutley Pathology group includes Discovery, Clinical Pathology and Pathology Laboratories, and is responsible for leading and providing input from early discovery to late development of the Company’s therapeutics.
The positions…
A pathologist in this position will provide scientific guidance and anatomic pathology support for basic research and preclinical safety projects in several therapeutic disciplines (mainly oncology and inflammation, respiratory and immune-mediated diseases, viral diseases and metabolic). Both small molecule and therapeutic protein programs are supported. This individual will be part of interdisciplinary teams with discovery scientists, toxicologists, pharmacologists, chemists and other professionals with the goal of designing strategies and screening studies to identify new drug candidates for treatment of human disease. Pathologists provide anatomic and clinical pathology evaluation/interpretation and input into risk assessment during compound development from pre-IND safety studies to registration studies. Additionally, evaluation of animal models for efficacy screening, toxicity screening for lead candidate optimization, tissue target profiling and biomarker development are critical aspects of these discovery/early development programs. Collaborations with scientists throughout Roche are encouraged.
Who you are…
This position requires a D.V.M. and certified training in pathology (ACVP/ECVP), preferably with PhD or proven research experience in a related field, ideally with 2 to 5 years experience in toxicologic pathology. Excellent communication skills, innovation and commitment, as well as the ability to prioritize toxicologic pathology work with discovery projects and contribute effectively to a sound, timely decision making process are essential. In addition, you’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point.
Posted May 26, 2010 Pfizer, Inc.
Groton, CT
Resident Postdoctoral Pathologist
The incumbent will prepare for and sit the certification examination of the American College of Veterinary Pathologists preferably in 2011, develop greater understanding of the roles of veterinary pathologists in pharmaceutical development and discovery, and support Drug Safety R&D through application of the scientific discipline of pathology. As a Study Pathologist, the incumbent will supervise necropsy and evaluate, interpret, and report clinical pathology and anatomic pathology data.
Special projects may include additional morphologic evaluations to support discovery or investigative programs. Participation in departmental and therapeutic area meetings, presentation of scientific data, and presentation of pathology case materials are expected. In addition, the incumbent will support the comparative medicine group with diagnostic cases and prepare cases for AFIP submission. The appointment is for a one-year term and is renewable for a successive one-year term depending on satisfactory progress.
Education (Minimum):
D.V.M. or equivalent and completion of advanced training program in veterinary pathology
Work Experience/Skills (Required):
Experience and skill in gross, microscopic, and ultrastructural findings in animals
Other Attributes Desirable:
Interest in a career in the pharmaceutical industry
Experience in pathology of laboratory animals
Good interpersonal skills.
Good written and oral communication skills
Demonstrated personal accomplishment in the field of Veterinary Pathology through scientific presentations and publications
Self-directed
Throughout our 153 years, a legacy of caring for others has been at the heart of everything we do at Pfizer. This commitment is no less important when it comes to our employees. Pfizer wants to ensure that employees have resources to help them develop and succeed both in their careers and personal lives. One way we can achieve this is through our comprehensive benefits program, which offers employees and their eligible dependents the variety and flexibility to help address their needs at different stages in life.
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act.
All applicants must have authorization to work for Pfizer in the U.S. In certain circumstances it may be advantageous to Pfizer to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U.S.
Posted May 24, 2010 Pfizer, Inc.
La Jolla, CA 92037
DSRD Regulatory Strategy Lead (R6-R7)
Position Purpose:
Serves as the primary author (with input/review by project team reps) of the regulatory dossier Nonclinical Overview (CTD/eIND/IMPD Section 2.4); integrates all nonclinical contributions (pharmacology/ADME/toxicology) to provide a critical, comprehensive nonclinical assessment of the pharmacologic, pharmacokinetic, and toxicologic attributes of the pharmaceutical; oversees the timeline for the nonclinical sections including coordination of document reviews; and has overall responsibility for the content, format and compliance of the dossier to international standards, and delivery of submission-ready components, working in conjunction with regulatory submission scientists and document specialists.
Develops and implements strategy to influence internal and external nonclinical requirements for clinical trial support and registration of pharmaceuticals.
Prepares and reviews correspondence with worldwide regulatory agencies (e.g., carcinogenicity study protocol assessment requests, responses to regulatory queries).
Provides input to project planning for J-IND and J-NDA; assures that local dossiers are reviewed for eventual acceptance of the toxicology package in Japan.
Provides nonclinical safety consultation and expertise regarding current international regulatory guidelines.
Prepares toxicology assessments for impurities, formulation components, cleaning validation, and manufacturing support.
Serves as nonclinical safety expert on Project Teams for Pfizer drug candidates and Assessment Teams for potential acquisition or licensing candidates. Communicates with TALs and TA Group Heads to design and implement strategy for specific projects in order to advance candidate selection, evaluation, file regulatory documents, and improve risk assessment and risk management of drug candidates in support of portfolio goals. Mentors project team representatives with less experience in late stage drug development strategy and processes. In this role, has a matrix relationship to DSRD TALs.
Educational Background:
PhD, MD, or D.V.M. with expertise in Toxicology, Pathology, or allied biological sciences.
Minimum:
5 years of related work experience
Desirable:
6–10 years
Work Experience/Skills:
Experience level should be within the range of moderate experience and competency in early and late stage drug development submissions to extensive experience and skill in crafting expert nonclinical summary documents and working directly with regulatory agencies and industry consortia on the regulations governing nonclinical pharmaceutical development. Expertise in structure-toxicity assessment and experience in safety assessment of impurities, excipients, and contaminants is a plus.
Expectations include a working knowledge of international regulatory guidelines and practices, demonstrated ability to author regulatory documents of high quality, appropriate decision making regarding candidate development and regulatory submissions, ability to communicate well across business lines, and effective leadership of teams of diverse expertise.
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act.
The successful candidate will actively participate in the discovery/characterization of novel drug targets, and in the pre-clinical development and safety assessment of novel therapeutic agents. The incumbent will interact with innovative scientists in several therapeutic areas, including functional genomics, endocrinology, cardiovascular diseases, immunology, and ophthalmology. This individual will be a senior member of the DMPK/Toxicology/Pathology Department and work closely with toxicologists providing expert analysis and interpretation of pathology findings from toxicology studies. An additional objective is to integrate in vivo test results with clinical and anatomic pathology findings in order to characterize complex phenotypes. Our veternary pathologists have access to in-house facilities for histology, immunohistochemistry, in situ hybridization, clinical pathology, and knockout mouse models. We are looking for a discovery oriented research pathologist who is an effective communicator, and an enthusiastic collaborator, able to exercise independent judgment in establishing approaches and methods related to pathology in a stimulating team-based environment. The successful candidate should have strong technical writing skills and a desire to master current knowledge in pertinent fields. In addition, this position could include managerial and supervisory responsibilities at a senior level.
Qualifications
D.V.M. or equivalent
Diplomate ACVP Required
Minimum 3 years experience in toxicological pathology
Proficiency with basic computer skills and data analysis
Excellent communication (both written and verbal) and
organization skills and the ability to write accurate, concise
pathology reports and phenotype project summaries
Ability to prepare reports, scientific manuscripts and deliver
presentations
Ability to function autonomously in a multidisciplinary team
Lexicon Pharmaceuticals, Inc. is an equal opportunity/affirmative action employer.
Posted April 16, 2010 Department of Molecular and Comparative Pathobiology
4-Year Postdoctoral Fellowship in Pathology
(Research Emphasis)
The Johns Hopkins Department of Molecular and Comparative Pathobiology invites applications for our 4-year postdoctoral fellowship (research emphasis). The successful candidate will receive 3 years of outstanding research training in a multi-disciplinary mentored environment in a discipline of their choice. Research training is preceded by one year of intensive training in anatomic pathology in preparation for certification by the American College of Veterinary Pathologists (ACVP). This training opportunity is comparable to the residency/PhD opportunities offered at many veterinary schools, but is distinguished by the much broader research opportunities afforded by a large medical institution, including the option to pursue a PhD in a stellar JHU graduate program.
Program
This is a 2-part program: three years of research training, funded by the National Institutes of Health, is preceded by a year of pathology training funded by the department. During the first year trainees gain outstanding clinical experience in anatomic pathology through gross and microscopic examination of pathology cases from the Johns Hopkins University animal colonies, local veterinary practitioners, the Maryland State Laboratory, the Maryland Zoo and the National Aquarium in Baltimore. In years 2 to 4, trainees undertake full-time mentored basic or applied research in a discipline of their choice. If desired, trainees may pursue a PhD concurrent with their research training. Our faculty includes 6 ACVP Diplomates, 4 ACLAM Diplomates, and 9 biomedical research scientists, whose research interests include retrovirology, neuropathology, cardiovascular disease, infectious disease, parasitology, carcinogenesis, proteomics, and rodent phenotyping (www.hopkinsmedicine.org/mcp). Trainees also may work with faculty from more than 30 academic departments forming Johns Hopkins Medicine.
Qualifications
This position is targeted for a veterinarian who wishes to pursue a career as an experimental pathologist in a research setting. Candidates must have a D.V.M. or equivalent degree, and be a citizen or permanent resident of the United States.
Applications
Submit your curriculum vitae, transcripts, three letters of recommendation, and a letter describing your (i) professional background, interests and goals, (ii) pathology experience and preparation, and (iii) plan for professional development. Materials should be mailed to Nancy Nath, Academic Program Coordinator, Johns Hopkins University, 733 N. Broadway, Suite 811, Baltimore, Maryland 21205, phone (443) 287-2953 or E-mailed to nnath2@jhmi.edu no later than September 30, 2010. Johns Hopkins University is an equal opportunity employer and educator.
Posted April 9, 2010 BioMarin
Senior Scientist
BioMarin is seeking a Senior Scientist to provide Toxicological expertise regarding the nonclinical development of BioMarin’s small molecule and biologic drug candidates. Will provide scientific leadership and play a pivotal role from late-stage research through nonclinical development for all phases of the drug development process including market application and commercialization.
Will lead/contribute to the toxicological assessment of BioMarin nonclinical therapeutics by creating a best-evidence synthesis of existing knowledge and by designing, implementing, interpreting, investigating toxicity relationships and reporting data that elucidates the toxicologic/pharmacologic profile of drug candidates. Will work collaboratively with internal and external cross-functional subteams, collaborators and consultants to plan and efficiently execute nonclinical pharmacology/toxicology programs that support clinical development and regulatory submissions. Studies that support BioMarin’s nonclinical programs are conducted in multiple species under non-GLP and GLP conditions depending on the objective of the studies. Comprehensive analysis and interpretations of these studies are reported and defended to regulatory agencies in meetings and documents including the IND/CTA, annual reports, investigator brochures, special protocol assessments and market applications.
Candidates must have an extensive pharmacology/toxicology background as well as a strong understanding of Good Laboratory Practices (GLPs) that will provide broad-based support to align nonclinical efforts with the company’s opportunistic philosophy of drug development. Will interact with scientists across the company in order to provide a balanced assessment as to the risk/benefit profile associated with a drug candidate’s advancement. Will also be responsible for the planning, implementation and organization of nonclinical studies along with the use of drug exposure to bridge across species, presentation of data to cross-functional core teams and subteams, external collaborators, and the scientific community. Will be directly involved in participating/leading project sub-teams and representing Pharmacological Sciences on cross-functional project teams.
Responsibilities:
Design, implement, interpret and report nonclinical studies to support small molecules and biologics in late-stage research and all stages of nonclinical/clinical development
Prepare study proposals, protocols, study reports and regulatory documents to support nonclinical development of BioMarin drug candidates
Interact with regulatory regions (i.e. FDA, EMEA, MHRA)
Interact with CROs, university laboratories, analytical laboratories, collaborators, both internal and external to BioMarin, as necessary to ensure appropriate/timely progression of BioMarin nonclinical projects
Interact with various BioMarin departments to ensure efficient cooperation with outside laboratories and regulatory agencies
Participate in multi-disciplinary drug development teams and lead sub-teams
Excellent written and verbal communication skills
Ability to build and foster productive cross-functional collaborations both within and external to BioMarin.
Education:
Doctorate (PhD) in toxicology or closely related field of study. Board Certification in Toxicology a plus.
AND/OR Veterinarian (D.V.M.) with Board Certification in Pathology
Experience:
Minimum 6 years of nonclinical toxicology experience in the pharmaceutical or biotechnology field
Strong understanding of drug development
Established ability to interact with various regulatory agencies
Established Drug Development Reputation
Experience to support special protocol assessments and carcinogenicity studies
Strong understanding of FDA and OECD Good Laboratory Practices
Veterinarian pathology experience (preferred)
To apply: Visit www.BMRN.com Job Code 10-0057, EEO/M/F/D/V
Posted March 23, 2010 Pfizer Inc.
Tissue Bank Lead (R7)
Groton, CT
The Tissue Bank Lead is responsible for overseeing the strategic and operational aspects of the Pfizer Tissue Bank, a global tissue repository supporting project teams and research groups across Pfizer. The Tissue Bank is located at Pfizer's Drug Safety Research and Development (DSRD) Groton site and is a component of a larger DNA and Biofluids repository (Pfizer BioBank) also located in Groton, CT.
Key responsibilities of this position include:
Strategic and scientific leadership of the Tissue Bank, including novel target discovery, target selection, biomarker identification, investigative use of clinical trial tissues, reagent characterization and identification of potential new indications.
Tissue procurement from academic and commercial vendors to meet the needs of Pfizer project teams and researchers.
Clinical trial support, including the receipt, storage, and disbursal of clinical trial tissues.
Identify emerging or prospective needs, including new groups and initiatives that could benefit from the services and expertise of the Tissue Bank.
Consultation on scientific and pathology issues, including immunohistochemistry, use of tissues as controls for reagent characterization, identification of potential tissue sources, informed consent and other tissue banking procedures.
Maintain collaborations across Pfizer to align the Tissue Bank with the global BioBank strategy and capabilities, including application of new technologies and informatics packages.
Develop and maintain ties with external influence group(s) and external organization(s) to enhance best practices and stay current with evolving scientific and legal/ethical understanding within the field.
The Tissue Bank Lead represents DSRD on the BioBank Board, assuring that Tissue Bank strategy is closely aligned with the global strategy for the Pfizer BioBank as a whole. In addition, the Tissue Bank Lead manages the laboratory resources (space and equipment), budget (scientific supplies and travel) and personnel (approximately 3 FTEs) of the Tissue Bank laboratory.
Educational Background (Minimum):
PhD, D.V.M., MD or equivalent. Scientific and technical expertise in the laboratory discipline of biospecimen banking and research applications.
Desirable:
Formal training and/or certification in Anatomic Pathology (ACVP, JCVP, MRCPath, ECVP or equivalent).
Work Experience/Skills:
Substantial experience in a relevant pathology position, either in academia, government or industry.
Anatomic Pathology training or experience in investigative/mechanistic pathology, immunohistochemistry, and molecular laboratory techniques utilizing tissue specimens
Supervisory and/or managerial experience.
Extensive pharmaceutical industry experience in Anatomic Pathology or molecular laboratory techniques.
Excellent verbal and written communication skills.
Demonstrated ability to work collaboratively, lead and manage in cross-line, multi-site environment.
Posted March 23, 2010 Pfizer Inc.
Veterinary Pathologist—Drug Development
Cambridge, MA
The Drug Safety R&D Department in Cambridge and Andover Massachusetts has an opening for an experienced Veterinary Pathlogist at the Senior Principle Scientist to Associate Research Fellow level. The pathologists in this group support the pathology needs of the Inflammation/Immunology, Biocorrection, Tissue Repair and Oligonucleotide Therapeutic research units located in Cambridge and Andover, MA. They also contribute to Pfizer’s global pathology needs. The position is based at the Cambridge, MA research site.
The successful candidates will provide pathology and toxicology support for drug discovery teams which focus on characterizing the safety of novel therapeutic targets, and discovering and developing new chemical or biologic entities intended to modulate those targets. The successful candidate for this position will have primary focus on supporting the development stage portfolio consisting of a diversity of therapeutic modalities including small organic compounds, nucleic acids and large molecular weight proteins.
In this capacity, they will serve as either the primary or peer-review pathologist for studies supporting the regulatory filing for compounds. For individuals with the appropriate breadth of experience, the opportunity exists to be the Drug Safety representative on Research & Development project teams and guide the safety strategy for a project from early discovery through development and registration. Depending on the interests and career aspirations of the individual, the opportunity also exists to support the early portfolio through the evaluation of animal models of disease. Pathologists will be supported by laboratories that will provide an infrastructure of state of the art histology, necropsy, molecular pathology, clinical pathology and quantitative imaging tools that enable them to answer critical scientific questions within the project teams. The opportunity also exists to be the lead on multidisciplinary teams intended to investigate mechanisms of toxicity that provide critical information enabling strategic decisions for project teams.
Key interactions will include Research & Development Project Teams that are identifying and developing new drug candidates and therapeutic targets, DSRD teams involved with evaluating target and compound safety, and multidisciplinary teams identifying new biomarkers of disease or toxicity. In addition to project team interactions, Pathologists will be co-located with investigative toxicology and biomarker groups which offer a tremendous opportunity for scientific collaboration.
Educational Background:
D.V.M. or equivalent
MINIMUM ACVP or ECVP Board-certification with 3–5 years experience as a study pathologist supporting the regulatory filing for large and/or small molecules
Desirable:
PhD or equivalent experience in research in a relevant scientific discipline
Work Experience/Skills:
Strong abilities to summarize, present and discuss scientific data. An interest and ability to engage individuals from a variety of scientific disciplines and incorporate their expertise into a holistic understanding of disease pathophysiology and toxicity. Desire for continuous improvement of overall skill sets and enthusiasm to contribute scientifically to drug discovery and development. Strong written communication skills and ability to work effectively on multidisciplinary teams.
Posted March 23, 2010 Pfizer Inc.
Veterinary Pathologist—Drug Discovery
Cambridge, MA
The Drug Safety R&D Department in Cambridge and Andover Massachusetts has an opening for a Veterinary Pathlogist at the Principle Scientist to Senior Principle Scientist level. The pathologists in this group support the pathology needs of the Inflammation/Immunology, Biocorrection, Tissue Repair and Oligonucleotide Therapeutic research units located in Cambridge and Andover, MA. They also contribute to Pfizer’s global pathology needs. This position is based at the Cambridge, MA research site.
The successful candidates will provide pathology and toxicology support for drug discovery teams which focus on characterizing the safety of novel therapeutic targets, and discovering and developing new chemical or biologic entities intended to modulate those targets. The diversity of therapeutic modalities will include small organic compounds, nucleic acids and large molecular weight proteins.
This position will have a primary focus on supporting the early stage portfolio and provide support for characterization of animal models and provide guidance on interpreting their relevance to human disease. They will design and interpret studies intended to develop an understanding of the safety and therapeutic potential of novel molecular targets as well as compounds intended to modulate those targets. Depending on the interests and career aspirations, pathologists may serve as primary or peer-review pathologists on regulatory toxicology studies supporting compound development. For individuals with the appropriate breadth of experience, the opportunity exists to be the Drug Safety representative on Research & Development project teams and guide the safety strategy for a project from early discovery through development and registration.
Pathologists will be supported by laboratories that will provide an infrastructure of state of the art histology, necropsy, molecular pathology, clinical pathology and quantitative imaging tools that enable them to answer critical questions within the project. The opportunity also exists to be the lead on multidisciplinary teams intended to investigate mechanisms of toxicity that provide critical information enabling strategic decisions for project teams.
Key interactions will include Research & Development Project Teams who are identifying and developing new drug candidates and therapeutic targets, teams involved with evaluating target and compound safety, and multidisciplinary teams identifying new biomarkers of disease or toxicity. In addition to discovery project team interactions, Pathologists will be co-located with investigative toxicology and biomarker groups which offer a tremendous opportunity for scientific collaboration.
Educational Background (Minimum):
D.V.M. or equivalent, PhD or equivalent experience in research in a relevant scientific discipline
Desirable:
ACVP or ECVP Board-certification
Work Experience/Skills:
Demonstrated ability to apply state of the art molecular pathology and/or quantitative morphologic imaging tools to address pathobiology questions. Strong abilities to summarize, present and discuss scientific data. An interest and ability to engage individuals from a variety of scientific disciplines and incorporate their expertise into a holistic understanding of disease pathophysiology and toxicity. Desire for continuous improvement of overall skill sets and enthusiasm to contribute scientifically to drug discovery and development. Strong written communication skills and ability to work effectively on multidisciplinary teams.
Posted March 9, 2010 Cubist
Scientist II—Toxicology
Lexington, MA
Job Type: Permanent
Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, & commercialization of pharmaceutical products that address unmet medical needs in the acute care environment.
Cubist & CUBICIN are registered trademarks of Cubist Pharmaceuticals, Inc. AstraZeneca & MERREM are registered trademarks of the AstraZeneca group of companies. Additional information can be found at Cubist’s Web site.
Position Summary:
Nonclinical Scientist II of Nonclinical Development Department will oversee the GLP IND-enabling safety pharmacology, pharmacokinetics, & toxicology testing for selected project candidates & the design of the testing plan to support clinical development. Specific responsibilities will include: nonclinical study design/protocol set-up, contract research laboratory (CRO) selection/study director interactions/monitoring, study result interpretation, report finalization, & preparation of Integrated Nonclinical Summary for IND & NDA submissions. This position regularly interacts with all levels of the organization, including Regulatory, Analytical Research, Discovery Research, Clinical Research, Quality Assurance, & Manufacturing groups, & will serve on selected Discovery & Development project teams as the lead NCD representative.
Responsibilities:
Design of nonclinical IND testing plan for selected programs
Oversee nonclinical study set-up/CRO selection
Study design & protocol development
Monitor in-life/raw data for nonclinical studies
Interpretation of study results & report finalization
Evaluate of literature for toxicity issues/in-licensing assessments
Serve on selected project teams
Experience Required:
PhD with 2–5 years post-graduate experience or a BS/MS with 5–10 years experience in nonclinical testing as a contract lab study director or supervisor in toxicology or biopharmaceutical company toxicologist. Candidates must also be familiar with the toxicology principles & testing designs, operations of nonclinical studies, & GLP regulations. Knowledge of pharmacokinetics or toxicology specialization is beneficial.
Desired Competencies and Qualifications:
Adaptability/Flexibility: Possess the ability work effectively within a fast paced & changing environment. The candidate will be able to respond enthusiastically and positively to organizational changes & changes in job demands.
Decision Making: Possess the ability to make sound scientific decisions by evaluating all factors & using judgment; the candidate will also possess the ability to assess the potential impact of their decisions.
Effective Planning: Utilize effective planning to facilitate goal achievement.
Perseverance: Pursue tasks & work towards achievement of goals with energy, drive, & initiative, even in the face of adversity & setbacks.
Problem Solving: Show an ability to understand a situation, task or problem by breaking it down into smaller pieces using a systematic approach & to identify patterns & connections between situations that are not obviously related.
Results Oriented: Drive issues to closure & get the job done in ways that are professional & are reflective of the Cubist code of conduct.
Posted February 25, 2010 Pfizer, Inc.
Veterinary Pathologist
Sandwich, GB
Job Type: Full Time
Salary: Salary commensurate with experience
Position Purpose:
Pfizer Pathologists contribute to a wide range of critical activities within Drug Safety/Toxicology. This includes study evaluation, peer review of toxicology studies and study monitoring of outsourced studies.
Pfizer Pathologists contribute to a wide range of critical activities within Drug Safety/Toxicology. This includes study evaluation, peer review of toxicology studies and study monitoring of outsourced studies.
Primary Duties:
Provide input on study design and expertise in pathology evaluation and reporting
Integrate data and present findings and interpretations in written and oral reports to peers, management, and regulatory agencies
Provide expert scientific review and oversight of pathology including peer-review and leading PWGs
Provide pathology expertise in research teams
Initiate and/or interpret studies to determine Confidence in Rationale, Confidence in Safety, target expression & safety and studies contributing to mechanistic understanding of target organ toxicities, and to evaluation of models of disease.
Integrate study findings for regulatory submissions
Design, interpret and report/communicate findings for various types of studies (e.g. regulatory, investigative, mechanistic)
Design, conduct, and communicate results of molecular pathology or special pathology studies
Consult with subject matter experts as necessary
Serve as project team representative and provide active support for Early Research and Target Safety activities
Contribute to the routine clinical pathology data within the pathology report
Qualifications:
D.V.M. or equivalent, PhD and/or ACVP or ECVP
Experience in toxicologic pathology and knowledge of regulatory requirements
Strong technical knowledge and ability in various aspects of toxicologic pathology
Strong ability to present, discuss and summarize relevant data
Focus on optimal delivery of safe and efficacious drugs to patients
Highly motivated team-player
Performance and results oriented
Throughout our 153 years, a legacy of caring for others has been at the heart of everything we do at Pfizer. This commitment is no less important when it comes to our employees. Pfizer wants to ensure that employees have resources to help them develop and succeed both in their careers and personal lives. One way we can achieve this is through our comprehensive benefits program, which offers employees and their eligible dependents the variety and flexibility to help address their needs at different stages in life.
PGRD's aim is to provide equality of opportunity in the recruitment process by avoiding discrimination on the grounds of: age, sex (physical characteristics you were born with), marital status, gender (self identity), sexual orientation, religion or belief, disability, colour, national or ethnic origin, political persuasion or trade union membership.
At Pfizer we are creating an organisation and promoting a culture that respects each individual's unique character and life experiences, and reflects the diversity of our customers and markets. We will achieve this through fostering and sustaining an environment in which every colleague feels valued and supported, thus enabling superior business results.
Posted February 1, 2010 Pfizer
DSRD Regulatory Strategy Lead
La Jolla, CA
Position Purpose:
Serves as the primary author (with input/review by project team reps) of the regulatory dossier Nonclinical Overview (CTD/eIND/IMPD Section 2.4); integrates all nonclinical contributions (pharmacology/ADME/toxicology) to provide a critical, comprehensive nonclinical assessment of the pharmacologic, pharmacokinetic, and toxicologic attributes of the pharmaceutical; oversees the timeline for the nonclinical sections including coordination of document reviews; and has overall responsibility for the content, format and compliance of the dossier to international standards, and delivery of submission-ready components, working in conjunction with regulatory submission scientists and document specialists.
Develops and implements strategy to influence internal and external nonclinical requirements for clinical trial support and registration of pharmaceuticals.
Prepares and reviews correspondence with worldwide regulatory agencies (e.g., carcinogenicity study protocol assessment requests, responses to regulatory queries).
Provides input to project planning for J-IND and J-NDA; assures that local dossiers are reviewed for eventual acceptance of the toxicology package in Japan.
Provides nonclinical safety consultation and expertise regarding current international regulatory guidelines.
Prepares toxicology assessments for impurities, formulation components, cleaning validation, and manufacturing support.
Serves as nonclinical safety expert on Project Teams for Pfizer drug candidates and Assessment Teams for potential acquisition or licensing candidates. Communicates with TALs and TA Group Heads to design and implement strategy for specific projects in order to advance candidate selection, evaluation, file regulatory documents, and improve risk assessment and risk management of drug candidates in support of portfolio goals. Mentors project team representatives with less experience in late stage drug development strategy and processes. In this role, has a matrix relationship to Drug Safety R&D Therapeutic Area Leads.
Educational Background:
PhD, MD, or D.V.M. with expertise in Toxicology, Pathology or allied biological sciences.
Minimum:
5 years of related work experience
Desirable:
6–10 years
Work Experience/Skills:
Experience level should be within the range of moderate experience and competency in early and late stage drug development submissions to extensive experience and skill in crafting expert nonclinical summary documents and working directly with regulatory agencies and industry consortia on the regulations governing nonclinical pharmaceutical development. Expertise in structure-toxicity assessment and experience in safety assessment of impurities, excipients, and contaminants is a plus.
Expectations include a working knowledge of international regulatory guidelines and practices, demonstrated ability to author regulatory documents of high quality, appropriate decision making regarding candidate development and regulatory submissions, ability to communicate well across business lines, and effective leadership of teams of diverse expertise.
Posted February 1, 2010 BASF SE
Senior Pathologist (f/m)
Ludwigshafen, Germany
As the leading company in the chemical industry, BASF SE open up future success potential together with our partners. For this purpose, we foster and develop partnerships that are marked by trust and mutual respect. With intelligent solutions, we help to make the future successful and sustainable. We set store by the strengths of our staff.
For our Experimental Toxicology and Ecology we are looking for a committed Senior Pathologist (f/m).
Your future tasks:
Group leader and manager for pathology and clinical pathology
Member of the management team of experimental toxicology and ecology
Provide microscopic and macroscopic tissue evaluations
Plan, evaluate and report the pathological evaluation of studies under GLP
Represent BASF in national and international panels as the leading pathologist
What we expect of you:
Specialized in veterinarian or human pathology e.g. board-certification ECVP, ACVP or veterinary specialist in pathology and profound experience in toxicological pathology
Strong leadership and management skills and experience
Excellence in interdisciplinary collaboration
Good English and communication skills
What we offer:
Active participation in developing our business in a very dynamic environment
Working in a motivated team with excellent career development opportunities within the BASF global network
We look forward to your application!
Dr. Wolfgang Kaufmann, phone: +49 621 60 56740, will be pleased to answer any
specialist questions that you may have.
BASF SE
HRdirekt - D 108
D-67056 Ludwigshafen, GERMANY
Tel. ++49 621 60-95200
Reference code: GV 51295696
Posted February 1, 2010 BASF SE
Pathologist (f/m)
Ludwigshafen, Germany
As the leading company in the chemical industry, BASF SE open up future success potential together with our partners. For this purpose, we foster and develop partnerships that are marked by trust and mutual respect. With intelligent solutions, we help to make the future successful and sustainable. We set store by the strengths of our staff.
For our Experimental Toxicology and Ecology we are looking for a committed Pathologist (f/m).
Your future tasks:
Lead and manage the laboratory for general pathology with several co workers
Provide microscopic and macroscopic tissue evaluations and oversee necropsies
Plan, evaluate and report the pathological evaluation of studies under GLP
Participate in the scientific development and establish new methods
Represent BASF in national and international panels on diagnostics and nomenclature in toxicological pathology
What we expect of you:
Specialized in veterinarian or human pathology. Should you not yet have fulfilled all requirements for specialization (e.g. board-certification ECVP, ACVP or veterinary specialist in pathology) we offer the possibility of completing your specialist training
Leadership and management skills
Be disposed to interdisciplinary collaboration
Good English and communication skills
What we offer:
We provide intensive "on the job" training in a competent team and help you to find
challenging opportunities to develop your career further on in a global enterprise.
We look forward to your application!
Dr. Wolfgang Kaufmann, phone: +49 621 60 56740, will be pleased to answer any
specialist questions that you may have.
BASF SE
HRdirekt - D 108
D-67056 Ludwigshafen, Germany
Tel. ++49 621 60-95200
Reference code: GV 51295696
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