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AbbVie Inc., Chicago, IL—Principal Pathologist / Senior Principal Pathologist - 1900805

Posted:
Company: AbbVie Inc.
Location: Chicago, IL
Job Title: Principal Pathologist / Senior Principal Pathologist - 1900805

Job Description:
The Department of Pathology in Preclinical Safety (PCS) at AbbVie has an opening for a Board-Certified Veterinary Anatomic Pathologist. The successful candidate will have a passion for bringing his/her scientific skills to the discovery and development of new medicines.

Key responsibilities will include:

  • Perform evaluation of pathology data sets and generate pathology reports for regulatory toxicity studies intended to support the development of new medicines
  • Perform pathology peer reviews
  • Provide expert scientific leadership in interpretation of pathology data in order to drive appropriate development strategies
  • Design and evaluate investigative studies to explore mechanisms of toxicity using appropriate technologies, including molecular, imaging, biomarker and other analyses
  • Contribute to regulatory submissions and other relevant documentation
  • Possibility to represent PCS on cross-functional project teams
  • Possibility to be involved in due diligences for in-licensing opportunities

Qualifications:

  • Essential:

    • Doctor of Veterinary Medicine (DVM or equivalent)
    • Board Certification in Veterinary Anatomic Pathology (ACVP or equivalent)

    Desirable:

    • Doctor of Veterinary Medicine (DVM or equivalent)
    • Board Certification in Veterinary Anatomic Pathology (ACVP or equivalent)

    Key Leadership Competencies:

    • Critical thinking and problem-solving skills
    • Strong interpersonal, written and oral communication skills
    • Ability to develop and execute complex strategies
    • Ability to build strong relationships with peers and cross functionally with partners outside of team to enable higher performance
    • Ability to be an active participant with leadership skills in multidisciplinary scientific teams
    • Strong sense of personal responsibility and integrity and strong commitment to quality

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Apply Online

Charles River Laboratories, Reno, NV—Clinical Pathologist II

Posted:
Company: Charles River Laboratories
Location: Reno, NV
Job Title: Clinical Pathologist II

Job Summary:
We are seeking an experienced Clinical Pathologist II, located in Reno NV. Charles River Laboratories Nevada employs a multidisciplinary group of scientists and technical staff that conduct investigative and IND-enabling preclinical studies in non-human primates, dogs and rats for drug development for pharmaceutical companies. The clinical pathology laboratory is equipped for hematology, clinical chemistry, coagulation, urinalysis and other specialty analyses. The successful candidate will join locally 3 board certified clinical pathologists and a laboratory staffed by 8 medical technologists and twenty support technicians and globally, a group of 13 board certified clinical pathologist located in USA, Canada and France. In addition, the clinical pathologists interact with a highly qualified staff of 9 board certified anatomic pathologists and 25 toxicologists and laboratory animal medicine veterinarians.

The Clinical Pathologist II's primary responsibility is the interpretation of study-related clinical pathology data and the generation of a clinical pathology report, as well as cytologic evaluations (i.e. bone marrow, blood smear, and effusions). Additional responsibilities include participation in scientific activities/projects related to clinical pathology within the organization.

Qualifications:

  • Education: D.V.M. / V.M.D. (Doctor of Veterinary Medicine) degree required. Ph.D. in Clinical Pathology or related discipline preferred.
  • Experience: Minimum 5 years related experience in clinical pathology or experimental pathology with demonstrated research capability as demonstrated by publications in peer-reviewed journals. Experience in the contract research or pharmaceutical industry with Postdoctoral experience or advanced/specialized education preferred.
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • Certification/Licensure: Board certification by the American College of Veterinary Pathologists (D.A.C.V.P.) Specialty in Clinical Pathology required.

Equal Employment Opportunity
Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet

Apply Online

Apple Inc., Cupertino, CA—Senior Toxicologist / Senior Biocompatibility Engineer - 200038754

Posted:
Company: Apple Inc.
Location: Cupertino, CA
Job Title: Senior Toxicologist / Senior Biocompatibility Engineer - 200038754

Job Summary:
Imagine what you could do at Apple. Do you care about how products perform, what makes them delightful yet keeps them safe and user-friendly in the deepest sense? Do you ever consider how much attention is put into Apple’s product design allows us to uphold user trust and confidence? The engineering team in Apple’s cutting-edge Product Safety group is responsible for ensuring our products meet international safety standards and regulations, but also exceed those requirements to befit Apple’s expectations.

Apple's Safer Materials and Biocompatibility team is seeking a toxicology professional to conduct toxicological assessments of materials used in the production of Apple products. We will look to you to identify substances that may be potentially hazardous to human health. You will work closely with Apple’s product design teams, program managers, and suppliers to track the use of materials, identify substances of concern, investigate safer alternatives, and support implementation of chemical substitution programs.

Key Qualifications:

  • Minimum of 3 years relevant industry experience in toxicology or equivalent field
  • Expertise in hazard identification, skin irritation/sensitization, risk assessment of substances, including alternative risk assessment methodologies
  • Experience with ISO 10993 and assessing materials for biocompatibility
  • Knowledge/experience with alternative testing methodologies and prediction models
  • Experience building dossiers, developing SOPs & test protocols
  • Excellent communication and presentation skills to technical and non-technical audiences
  • Proven ability to excel in a dynamic, schedule-driven environment

Description:
This position is offered in Apple's Environmental Technologies group of Apple's Hardware Engineering division. Our mission is to deliver the world's leading programs on the elimination of hazardous substances, improved material and energy efficiency, as well as design for environment. Apple believes that major improvements in environmental performance will be delivered through product design innovations.

We rely on your expertise in assessments on the toxic nature of chemical substances of materials used in the manufacture of wearable and non-wearable products that meet the prolonged skin contact requirements. You will focus primarily on the calculation of exposure to chemical substances, evaluation of their inherent hazardous properties, and identification of potential risks from the use of materials in Apple products and processes. You will be a major contributor in building Apple specifications, policies, and processes that place limitations on substances that are potentially hazardous to human health. You will contribute to the development of novel test methodologies to identify restricted substances and potential risks. You will also work with cross-functional partners, program managers and suppliers towards alternative assessments that identify safer substances and support substitution programs with suppliers.

Education:

  • PhD in toxicology or related field with 3 + years experience in an industry setting
  • MS in toxicology or related field with 10 + years experience in an industry setting
  • DABT certification is a plus
Apple is an Equal Opportunity Employer that is committed to inclusion and diversity. We also take affirmative action to offer employment and advancement opportunities to all applicants, including minorities, women, protected veterans, and individuals with disabilities. Apple will not discriminate or retaliate against applicants who inquire about, disclose, or discuss their compensation or that of other applicants.

Apply Online

Charles River Laboratories, Mattawan, MI—Clinical Pathologist II

Posted:
Company: Charles River Laboratories
Location: Mattawan, MI
Job Title: Clinical Pathologist II

Description:
We are seeking an experienced Clinical Pathologist II for our Clinical Pathologist department in Mattawan MI.

The following are responsibilities related to the Clinical Pathologist II:

A Clinical Pathologist II is responsible for all aspects of clinical pathology conducted on research studies. Partner with Study Directors to provide comprehensive interpretation and preparation of the clinical pathology portions of reports. Participate in protocol development, measurement of hematology, coagulation, clinical chemistry, and urinanalytical parameters

The following are minimum requirements related to the Clinical Pathologist II position:

  • Education: D.V.M. / V.M.D. (Doctor of Veterinary Medicine) degree required. Ph.D. in Clinical Pathology or related discipline preferred.
  • Experience: Minimum 5 years related experience in clinical pathology or experimental pathology with demonstrated research capability as demonstrated by publications in peer-reviewed journals. Experience in the contract research or pharmaceutical industry with Postdoctoral experience or advanced/specialized education preferred. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • Certification/Licensure: Board certification by the American College of Veterinary Pathologists (D.A.C.V.P.) Specialty in Clinical Pathology required.
  • Other: Full understanding of regulatory requirements, Good Laboratory Practices (GLPs), site SOPs, and of study types assigned. Knowledge of applicable international guidelines for all types of toxicology studies. Demonstrate leadership skills as they pertain to intra- and interdepartmental initiatives, Sponsor interactions, and business development. Effective written and verbal communication skills. Ability to handle multiple projects, prioritize work and meet deadlines. Proficiency in the use of standard software including Microsoft® Excel, Word, PowerPoint, etc. and with standard laboratory calculations and statistical interpretation.

For more information, please visit www.criver.com.

Equal Employment Opportunity
Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet

Apply Online

Experimur, Chicago, IL—Board-Certified Veterinary Pathologist

Posted:
Company: Experimur
Location: Chicago, IL
Job Title: Board-Certified Veterinary Pathologist

Description:

A privately-owned, Chicago-based contract toxicology testing and research laboratory, specializing in the conduct of pre-clinical studies, has an opening for a Board-Certified Veterinary Pathologist.

Candidates must have a DVM degree with a minimum of 5 years of experience (post board certification) in full-tissue toxicologic pathology of GLP-compliant pre-clinical studies conducted in multiple species (rodents to primates).

Responsibilities include:

  • Oversight of the in-house histology staff and laboratory
  • Supervising scheduled and unscheduled necropsies of various species used in toxicology studies (rodents to primates)
  • Serving as Study Pathologist for on-going toxicology studies conducted in compliance with FDA, EPA and OECD testing guidelines
  • Writing and reviewing pathology reports
  • Outsourcing and managing the overflow of pathology services.

The position requires a dynamic individual with excellent technical, writing, communication and management skills to serve as the focal point for the company’s pathology-related services both internally and externally with Sponsors and suppliers.

The company offers a competitive salary and a package of benefits including a profit-sharing plan.

Interested parties may contact Dr. Nabil Hatoum at 773-254-2700 ext. 231 or send a message along with their resumes via e-mail to nhatoum@experimur.com.

MD Anderson Cancer Center, Houston, TX—Assistant/Associate Professor, Research Faculty Appointment (RFA)

Posted:
Company: MD Anderson Cancer Center
Location: Houston, TX
Job Title: Assistant/Associate Professor, Research Faculty Appointment (RFA)

Description:

As a veterinary pathologist he/she will assist the Section Chief in the operation of the anatomical and clinical pathology laboratories in the Department of Comparative Medicine. This includes both direct and indirect management of technical personnel within the section and the fiscal management and planning for each of the respective laboratories. He/she is responsible for providing accurate, high quality anatomical, clinical, and experimental pathology data and analytical data generated in the laboratory. He/she will perform basic research, independent and/or collaborative, that contributes to the knowledge base of the Cancer Center, strengthens translational research activities, and satisfies the goals of the Department.

Candidate must have earned a Doctor of Veterinary Medicine degree (or equivalent) from an American Veterinary Medical Association-accredited university and be legally qualified to practice veterinary medicine in some state, province, territory, or possession of the Unites States. He/she must be certified or eligible for certification by the American College of Veterinary Pathologists, eligible for USDA accreditation and eligible for state and federal registration to handle controlled substances.

Candidates must have a minimum five years experience as a veterinary pathologist (this would include formal training under the supervision of a Diplomate of the ACVP) in an institution that trains veterinary pathologists as one of its primary functions. He/she must meet institutional requirements for an academic appointment as an Assistant/Associate Professor, and must be recognized by peers as possessing expertise in the field of veterinary pathology and laboratory animal medicine.

Please send a curriculum vitae to:

Christian R. Abee, D.V.M., M.S., DACLAM
Doctor R. Lee Clark Professor and Chair
Department of Comparative Medicine Director,
Michale E. Keeling Center for Comparative Medicine and Research
University of Texas, MD Anderson Cancer Center
Bastrop, TX 78602
Email: cabee@mdanderson.org
Telephone: 512-321-3991

MD Anderson Cancer Center is an equal opportunity employer and does not discriminate on the basis of race, color, religion, age, national origin, sex, sexual orientation, gender identity/expression, disability, veteran status, genetic information, or any other basis protected by federal, state, or local laws, unless such distinction is required by law. All positions at The University of Texas MD Anderson Cancer Center are security sensitive and subject to examination of criminal history record information. Smoke-free and drug-free environment.

Leidos Biomedical Research, Inc., Frederick, MD—Post-Doctoral Fellow, Sr

Posted:
Company: Leidos Biomedical Research, Inc.
Location: Frederick, MD
Job Title: Post-Doctoral Fellow, Sr

Description:

The Laboratory Animal Sciences Program (LASP) supporting research at the Frederick National Laboratory for Cancer Research and the National Cancer Institute (NCI) in Frederick, MD is offering a one-year post-doctoral fellowship for veterinary pathologists seeking experience in the field of molecular and mouse pathology and advanced training in pre-clinical cancer research using animal models. Fellows will train under a team of veterinary pathologists in the Pathology/Histo-technology Laboratory (PHL) and participate in digital pathology, interpretation of molecular assays (ISH, IHC, RNAscope), and interpretation of gross and histologic lesions. We expect that trainees will leave this highly-collaborative program with a wealth of information on the use of mouse phenotyping pathology, become familiar with a wide variety of quantification methods using image analysis software, and be prepared to conduct high impact cancer research focusing on state-of-the-art phenotyping technologies. As this fellowship is designed to assist candidates in preparing for boards (ACVP, ECVP), board preparation time will be allowed.

Key Roles/Responsibilities:

  • Participate in all phases of pathology research, including gross and microscopic examination of a variety of laboratory animal species, molecular pathology, digital imaging, and advance histologic techniques (tissue microarray construction, laser-capture microscopy, nucleic acid characterization, etc.)
  • Utilize advanced image analysis software such as HALO and Aperio to provided computer assisted and quantitative digital slide analysis.
  • Assist with the diverse diagnostic caseload within the National Cancer Institute.
  • Participate in research meetings and seminars.

Basic Qualifications:

  • Doctor of Veterinary Medicine from an accredited college/university or equivalent degree according to the Council for Higher Education Accreditation (CHEA) in a related field (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
  • In addition to educational requirements, completion of at least three (3) years of postdoctoral research and training is required for appointment at this level.
  • Applicants must have had at least two years of formal anatomic pathology training.
  • Must be able to obtain and maintain a security clearance.

Preferred Qualifications:

  • Preference will be given to those who have completed a three-year anatomic pathology residency.

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

Please visit the link to review the complete job description and to apply

Apply online.

Seventh Wave Laboratories, LLC - BASi, Maryland Heights, MO—Director of Pathology

Posted:
Company: Seventh Wave Laboratories, LLC - BASi
Location: Maryland Heights, MO
Job Title: Directory of Pathology

Description:

We are looking for a toxicologic pathologist with industry experience and a strong scientific background to lead our pathology team. The Director of Pathology will contribute to Pathology strategic planning and project implementation for Seventh Wave and BASi across all sites. Seventh Wave Pathology includes Discovery/Investigative Pathology and Regulated Nonclinical Development Pathology. The Director of Pathology will interface and coordinate with pathologists involved in Discovery and Regulated Pathology at all Seventh Wave/BASi sites. The Director will also remain engaged in the practice of pathology through participation is studies as a contributing scientist or PI and through peer review.

Essential Responsibilities:

  • Coordinates with the CSO on science-related issues, strategic planning, and evaluation of new initiatives or pathology-related technologies
  • Leads Seventh Wave/BASi pathology group and implements organizational goals related to pathology
  • Models and encourages strong ethics, integrity and company Core Values
  • Supervises and develops staff pathologists engaged in toxicological pathology
    • Oversees training of new pathologists
    • Peer reviews or assigns other experienced pathologists to peer review work of new pathologists as necessary
    • Provides management review of pathology reports
  • Manages procedures for Pathology to optimize scientific excellence, customer service, and interdisciplinary communication
    • Distributing pathology workload
    • SOP updates and maintenance
    • Report templates, writing standards, and standard lexicon
    • Process maps
  • Collaborates with Quality Assurance and Facilities Management staff to ensure regulatory compliance
  • Represents the company through meeting or conference attendance, client visits and communication, and other professional activities
  • Assists with and supports business activities as required, including budgeting and quoting.

Education/Experience:

  • A DVM or equivalent degree and advanced training and expertise in pathology, as evidenced by Board certification (ACVP/EXVP).
  • 10 years relevant Discovery and/or Toxicologic pathology experience in a contract research organization and/or pharmaceutical/biotech setting with a strong working knowledge of GLP regulations and nonclinical drug development
  • Experience from discovery through development preferred
  • Leadership or management experience with solid interpersonal skills to influence and drive decisions within cross-functional teams
  • Ability to form productive collaborations with scientists and leaders across multiple disciplines

Company Information:

BASi and Seventh Wave Laboratories combined operations in July 2018 to provide broader solutions and greater scientific expertise to our clients. With locations in West Lafayette & Evansville, Indiana, and Maryland Heights, Missouri, our comprehensive portfolio of in vivo and analytical services and innovative instruments focuses on goal attainment from lead optimization through regulatory enabling studies. With the experience and capacity to be impactful, while being small enough to be agile, we provide exceptional care and diligence to all our clients and their projects. Our approach combines toxicology, histopathology, and bioanalytical chemistry services for fast start times and on-time delivery.

Contact for Further Information:
Kristen J. Nikula, DVM, PhD, DACVP, FIATP
Chief Scientific Officer and Senior Director Toxicology and Pathology
Seventh Wave Laboratories LLC
19 Worthington Access Drive
Maryland Heights, MO 63043
Telephone: 314-628-1115


Please visit the link to review the complete job description and to apply

Apply online.

Pfizer Inc., Pearl River, NY—Associate Research Fellow, Pathology

Posted:
Company: Pfizer Inc.
Location: Pearl River, NY
Job Title: Associate Research Fellow, Pathology, 4733132

Description:

Pfizer has an exciting career opportunity available in our Drug Safety Research organization at our Pearl River, NY state site for a Global Pathologist. Bring your diverse experiences and work with world-class thinkers and leaders with world-class resources within an exceptional, science focused environment.

The Global Pathologist will be a motivated, intellectual partner heavily involved in study design and evaluation in order to develop an understanding of drug mechanisms of action, biomarkers, toxicity, and their relevance to humans to further advance therapies for unmet medical needs. You will be supporting our therapeutic areas: Oncology, Rare Disease, Vaccines, Internal Medicine, and Inflammation and Immunology.

The Global Pathologist will be managed and supported by a highly accomplished, board certified pathologist.

Please visit the link to review the complete job description and to apply

Apply online.

Frontage Laboratories, Concord, Ohio—Staff Pathologist

Posted:
Company: Frontage Laboratories
Location: Concord, Ohio
Job Title: Staff Pathologist

Description:

The Preclinical group at Frontage Laboratories is seeking a highly-motivated veterinary pathologist to join our team in PA or OH. The candidate will be expected to provide scientific expertise and leadership by contributing to the safety assessment of potential therapeutic and chemical agents for various species. The candidate should possess an in-depth understanding of anatomic pathology, and have experience in designing and critically evaluating results of exploratory and GLP-compliant toxicology and safety studies. Previous experience in authoring and reviewing nonclinical regulatory documents as well as interactions with regulatory authorities are required. This position will be part of the Preclinical team supporting multiple programs at all stages of development in various therapeutic areas.

Responsibilities

Diagnose and interpret compound-related effects in animals including assessment of cause of death, target organs of toxicity and reversibility of toxicity by providing expert primary pathology reads on exploratory and definitive toxicity studies. Serve as the Peer Reviewer Pathologist supporting GLP compliant toxicity studies performed for clients. Manage toxicology/pathology related program-specific plans and timelines.

Education / Experience

  • Experience performing pathology assessments in the pharmaceutical industry, or other GLP environment, and demonstrated in-depth understanding of the regulatory issues pertaining to pathologic data interpretation and presentation are required.
  • DVM with Board certification in American College of Veterinary Pathology is required.
  • 5+ years in preclinical safety assessment of novel therapeutic entities.
  • Knowledge of GLP compliance and relevant ICH & FDA guidance documents.
  • Outstanding interpersonal skills and verbal and written communication skills.
  • Ability to work effectively both independently and collaboratively in a dynamic team-oriented environment.
  • Ability to work well with Sponsors and collaborators with professionalism and discretion.
  • Ability to travel to monitor studies at our Ohio facility.
  • Outstanding organizational skills/ability to prioritize and deliver in timely fashion.

Qualified candidates may send their resume to Concord HR or apply online

Frontage is an equal opportunity employer.

Pfizer Inc., Pearl River, NY—Senior Principal Scientist, Pathology

Posted:
Company: Pfizer Inc.
Location: Pearl River, NY
Job Title: Senior Principal Scientist, Pathology, 4733181

Description:

Pfizer has an exciting career opportunity available in our Drug Safety Research organization at our Pearl River, NY state site for a Global Pathologist. Bring your diverse experiences and work with world-class thinkers and leaders with world-class resources within an exceptional, science focused environment.

The Global Pathologist will be a motivated, intellectual partner heavily involved in study design and evaluation in order to develop an understanding of drug mechanisms of action, biomarkers, toxicity, and their relevance to humans to further advance therapies for unmet medical needs. You will be supporting our therapeutic areas: Oncology, Rare Disease, Vaccines, Internal Medicine, and Inflammation and Immunology. The Global Pathologist will be managed and supported by a highly accomplished, board certified pathologist.

Please visit the link to review the complete job description and to apply

Apply online.

Pfizer Inc., La Jolla, CA—Associate Research Fellow, DVM Pathologist

Posted:
Company: Pfizer Inc.
Location: La Jolla, CA
Job Title: Associate Research Fellow, DVM Pathologist, 4374081

Description:

The Drug Safety R&D Department in La Jolla, California has an opening for an experienced Veterinary Pathologist to join a group of 4 veterinary pathologists at the La Jolla site. The pathologists in this group support Pfizer’s global pathology needs with a focus on the research unit (Oncology) located in La Jolla. There is significant interaction with pathologists located at Pfizer’s other R&D sites.

The pathologist will contribute to the design and be responsible for evaluating and reporting exploratory and GLP safety studies that evaluate the toxicity of small and large molecules in rodent and non-rodent species.

Please visit the link to review the complete job description and to apply

Apply online.

Bristol-Myers Squibb, New Brunswick, NJ—Industry Anatomic Pathology Fellowship

Posted:
Company: Bristol-Myers Squibb
Location: New Brunswick, NJ
Job Title: Industry Anatomic Pathology Fellowship

Description:

Drug Safety Evaluation (DSE), Bristol-Myers Squibb (BMS), New Brunswick, NJ, USA Program Offered:

The Department of Pathology in DSE at BMS is offering a 2 to 3-month industry fellowship for students wishing to gain practical experience in toxicologic anatomic pathology. Opportunities may be available for highly motivated board-eligible or recently boarded anatomic pathologists who demonstrate interest in toxicologic pathology. Successful applicants will have the opportunity to observe different phases of Good Laboratory Practices (GLP) and non-GLP studies conducted in a GLP setting, from study design and protocol review to necropsy, microscopic evaluation, data entry and data interpretation. Studies are conducted in multiple laboratory animal species in the context of preclinical safety assessment, providing participants with exposure to a wide array of background and drug-induced lesions.

Participants will also be involved in consensus and investigative response team meetings with program team members (e.g. general toxicologists/study directors, clinical pathologists, toxicokineticists, immunotoxicologists, laboratory animal veterinarians, genetic/reproductive toxicologists). Participants will also gain insight into the critical role of the study pathologist in characterizing mechanisms of drug pharmacology and toxicity and informing decision-making for drug development. This program is not intended to provide independent research components, but it may provide time and opportunity for small research projects and interactions with other scientists in the department. A stipend will be provided to cover housing and living expenses during the course of training.

Facilities:

Bristol Myers Squibb is a global healthcare company that has been working to discover, develop, and deliver innovative medicines that help patients prevail. We are committed to scientific excellence and investment in biopharmaceutical research and development to provide innovative, high-quality medicines that address the unmet medical needs of patients with serious diseases. We apply scientific rigor to produce clinical and economic benefit through medicines that improve patients' lives. We strive to make information about our commercialized medicines widely and readily available.

The fellowship will take place in a GLP test facility owned and operated by BMS in New Brunswick, NJ. The facility is a fully staffed laboratory with capabilities for all common ancillary procedures such as flow cytometry, immunohistochemistry, and laser capture microdissection. There is a total of 7 ACVP-boarded anatomic pathologists and 1 ACVP-boarded clinical pathologist in the DSE pathology department. Access to control tissues from a wide range of laboratory animal species and BMS extensive historical control database provides a strong background in animal species that are not traditionally assessed in the academic residency training (mice, rats, non-human primates, and rabbits). Reviewing toxicology studies in conjunction with BMS pathologists provides a unique opportunity to experience and learn from hands-on training in general toxicologic pathology. Abundant self-study materials are available, including slide sets from GLP and non-GLP studies, digital imaging capability and image archives, journals, and books.

Applications:

Applicants should be highly motivated, currently enrolled in a veterinary anatomic pathology residency with at least 2 years of experience or have completed a veterinary anatomic pathology residency and be enrolled in a PhD program. Applications should include Curriculum Vitae, a letter of interest, and contact information for a faculty member from their institution willing to serve as a reference.

Please submit your application via e-mail with a subject heading of "Fellowship"

Direct enquiries to: Muthafar Al-Haddawi

MyoKardia, South San Francisco, CA—Director, Toxicology and Pathology

Posted:
Company: MyoKardia
Location: South San Francisco, CA
Job Title: Director, Toxicology and Pathology

Summary

The Director of Toxicology and Pathology will contribute to development of strategy and planning for Nonclinical Toxicology and Pathology for MyoKardia programs and be primarily responsible for execution of a subset of all programs. This position reports to the Head of Toxicology and Pathology in the Nonclinical and Pharmaceutical Development function.

Essential Duties and Responsibilities

This position will be responsible for:

  • Lead all aspects of toxicology and pathology assessment for a subset of MyoKardia Research and Development programs
    • Design and oversee toxicology and safety pharmacology studies
    • Evaluate and select Contract Research Organizations (CROs)
    • Peer review studies
    • Review and finalize reports
    • Develop overall toxicology strategy for each program assigned
  • Represent Toxicology and Pathology on MyoKardia project teams
    • Participate as a key member of core project teams helping direct nonclinical development activities
    • Lead nonclinical sub teams as needed
  • Accountable for the execution of project toxicology plans
    • Responsible for delivering program studies on time and in budget
    • Monitors study progress and performs site visits and peer reviews
    • Supervise toxicologists within the department monitoring program studies.
  • Support regulatory submissions and approvals through the timely provision of data and its analysis
  • Support the selection of development candidates
  • Lead the nonclinical contribution to IND’s, Investigational Brochures, Regulatory Briefing Documents, and other relevant documentation for assigned programs
  • Take primary responsibility for all toxicology study conduct and data analysis and interpretation, reporting and communication
  • Ensure consistency of nonclinical content and scientific messages across publications and materials
  • Use innovative technology, including state-of-the-art imaging, biomarker, and genetic analysis, to optimize our understanding of molecules in development at MyoKardia

Education/Experience/Skills

Education:

  • DVM or MD with pathology training is required, preferably with diplomate status in appropriate organization (ACVP, ECVP, ABP, etc.)
  • Ph.D. in an affiliated discipline is a plus but not required

Experience:

  • Typically requires a minimum of 3–5 years of related experience and/or combination of experience and education/training research in the toxicology or biotechnology/pharmaceutical industry. Experience in cardiovascular drug development is desirable.

Knowledge/Skills/Abilities:

  • Solid understanding of Nonclinical drug development, ideally with relevant CV therapeutic area experience
  • Expertise in toxicology and study design principles meeting GLP/ICH requirements, and other Regulatory congentsiderations
  • Leadership: Experience leading and motivating teams in a matrix environment is required. Proven interpersonal skills with ability to influence, resolve conflict and drive decisions among internal cross functional teams, executive management, and external teams
  • Strategic Agility: Ability to develop and execute complex strategies
  • Ability to effectively collaborate in and across multiple functions, and with internal and external stakeholders of various backgrounds and skill sets. Skilled in establishing a collaborative and respectful environment
  • Demonstrated decision-making skills taking multiple perspectives into account and analytical skills are required; exercises sound business judgment that has broad organizational impact. Publication supporting these skills are a plus
  • Communication: Excellent communication skills (both orally and written) is critical to the success of the role
  • Business Excellence: Good at developing the processes necessary to get things done, knows how to organize people and activities, and knows what to measure and how to measure
  • Demonstrated ability to interpret data into actionable items

Apply online.

Omeros Corporation, Seattle, WA—Principal Scientist / Associate Director, Toxicology

Posted:
Company: Omeros Corporation
Location: Seattle, WA
Job Title: Principal Scientist / Associate Director, Toxicology

Summary

Omeros is seeking a Principal Scientist/Associate Director, Toxicology who has experience designing, planning and executing nonclinical development plans for both small molecules and biologics. Reporting to the Sr. Director, Toxicology, you will be responsible for conducting, interpreting and reporting nonclinical animal studies outsourced to contract research organizations (CROs), as well as serving as the Toxicology representative to internal Omeros multidisciplinary project teams. Expert knowledge of GLP regulations and regulatory guidelines is essential as you’ll serve as the primary author of the nonclinical sections of both US and international regulatory dossiers supporting clinical trials and eventual marketing applications.

Who is Omeros?

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases and disorders of the central nervous system.

The company’s drug product OMIDRIA® (phenylephrine and ketorolac injection) 1% / 0.3% is marketed in the U.S. for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.

Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington’s disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a diverse group of preclinical programs and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.

Come and join our highly talented Nonclinical Team and help shape the future of Omeros!

What will your responsibilities be?

Your specific job responsibilities will include:

  • Applying a broad understanding of toxicology, pharmacology, ADME, and knowledge of applicable regulatory guidelines to the design of appropriate toxicology studies and development plans
  • Providing creative approaches to expedite nonclinical development strategies
  • Providing a critical review of toxicology study protocols, data and study reports
  • Serving as the Toxicology representative on multi-functional project teams supporting discovery and development phase projects
  • Contributing to the preparation of high-quality regulatory documents supporting global clinical development and marketing authorizations
  • Effectively communicating toxicology study results to project teams and senior level management

Education and experience needed:

You’ll need to have a PhD in Toxicology or a related field with a minimum of 4 years of industry experience as part of a drug development project team; a BS/MS will be considered. Additionally, you’ll need the following:

  • Substantial nonclinical development experience at a pharmaceutical or biotechnology company
  • Experience in designing, monitoring and interpreting nonclinical toxicology/safety pharmacology studies
  • Experience in writing nonclinical sections of regulatory documents (CTA, IND, IB, NDA, BLA, etc.) and direct interactions with worldwide regulatory agencies
  • Certification by the American Board of Toxicology (DABT) is highly desired

Skills and knowledge we are seeking:

  • A strong scientific knowledge of toxicology, with expert knowledge in one or more specialty areas of the discipline
  • A strong working knowledge of US and international regulatory guidelines
  • Familiarity with drug development strategies for both small molecules and biologics
  • Ability to be proficient and work independently and in cross-functional team settings, building productive collaborations, managing conflict, multi-tasking, and prioritizing
  • Excellent written and verbal communication skills
  • Demonstrated ability to build and maintain positive relationships with management, peers and external customers
  • Strong sense of personal responsibility, creativity and integrity

This is an opportunity for you to be a key member of a collaborative group contributing your talent and expertise to a company that has an exciting pipeline. If you have the knowledge, skills and experience we are looking for, we’d love to hear from you!   

Omeros is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, age, marital status, or any other factor determined to be unlawful by federal, state, or local statutes.

It is our policy to provide reasonable accommodation to anyone with a disability who needs assistance completing the job application process. If you need assistance, you can either send an e-mail to hr@omeros.com or contact Omeros, asking for Human Resources, at (206) 676-5000.

Apply online.

Charles River Laboratories, Reno, NV—Clinical Pathologist II

Posted:
Company: Charles River Laboratories
Location: Reno, Nevada
Job Title: Clinical Pathologist II

Summary

Charles River Laboratories Nevada employs a multidisciplinary group of scientists and technical staff that conduct investigative and IND-enabling preclinical studies in non-human primates, dogs and rats for drug development for pharmaceutical companies. The clinical pathology laboratory is equipped for hematology, clinical chemistry, coagulation, urinalysis and other specialty analyses. The successful candidate will join locally 3 board certified clinical pathologists and a laboratory staffed by 8 medical technologists and twenty support technicians and globally, a group of 13 board certified clinical pathologist located in USA, Canada and France. In addition, the clinical pathologists interact with a highly qualified staff of 9 board certified anatomic pathologists and 25 toxicologists and laboratory animal medicine veterinarians.

The Clinical Pathologist II’s primary responsibility is the interpretation of study-related clinical pathology data and the generation of a clinical pathology report, as well as cytologic evaluations (i.e. bone marrow, blood smear, and effusions). Additional responsibilities include participation in scientific activities/projects related to clinical pathology within the organization.

Qualifications

  • Education: DVM/VMD (Doctor of Veterinary Medicine) degree required. PhD in Clinical Pathology or related discipline preferred.
  • Experience: Minimum 5 years related experience in clinical pathology or experimental pathology with demonstrated research capability as demonstrated by publications in peer-reviewed journals. Experience in the contract research or pharmaceutical industry with Postdoctoral experience or advanced/specialized education preferred.
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • Certification/Licensure: Board certification by the American College of Veterinary Pathologists (DACVP) Specialty in Clinical Pathology required.

Apply online.

Toxicologic Pathology Associates, Inc., Jefferson, AR—Toxicologic Pathologist/Associate Director

Posted:
Company: Toxicologic Pathology Associates, Inc.
Location: Jefferson, Arkansas
Job Title: Toxicologic Pathologist/Associate Director

Company Information

TPA is an employee-owned and operated small business Contract Research Organization (CRO) founded in 2004 to primarily support the FDA’s investigative pathology needs onsite at the National Center for Toxicological Research (NCTR) in Jefferson, Arkansas. Many of our staff have worked closely with Federal investigators for several decades and are part of a productive collaborative team effort that is critical to the success of the FDA and HHS mission to promote and protect public health.

The successful candidate will enjoy not only the benefits of being part of the vibrant NCTR research community where academia and regulatory scientists research, learn and train, but this opportunity offers the selected pathologist to immediately assume leadership responsibilities as a key member of a toxicologic pathology team that is vital to the prestigious multi-million dollar Interagency Research Agreement (IAG) that combines the resources of both the FDA/NCTR and the NIEHS’s National Toxicology Program (NTP). The unique IAG aspect of this opportunity facilitates active collaborative interactions with internationally recognized FDA and NTP researchers and, encourages start-to-finish interactions with members of the NTP’s highly respected pathology group and the impressive NTP network of contract and consulting pathologists.

TPA pathologists and our veteran technical support staff are called upon to help answer some of regulatory science’s most difficult questions—a target identification problem solving challenge that routinely combines multiple species large-scale traditional gross and microscopic toxicologic pathology approaches with advanced sub-cellular and molecular pathology-based technology to include IHC, ISH, and TMA with sophisticated digital imaging and stereologic analysis.

Essential Responsibilities

  • Participate in general project development and study protocol design for product specific safety-assessments and target identification/validation
  • Perform macroscopic and microscopic evaluation of tissues and correlate findings with organ weight, clinical pathology, and innovative target-specific studies using IHC and molecular pathology techniques in GLP and non GLP studies
  • Supervise necropsies involving a wide variety of laboratory animals and provide scientific guidance to necropsy technicians to ensure accuracy and compliance with applicable regulatory requirements, protocols and Standard Operating Procedures (SOPs)
  • Author comprehensive pathology narrative reports detailing all gross and microscopic findings while meeting report deadlines
  • Perform scientific review of manuscripts
  • Leverage strong communication and writing skills to actively participate in a rich peer review presentation and publication environment
  • Provide experienced pathology support in the interpretation of chemical or drug related toxicology findings
  • Leverage skills in specialty areas such as molecular pathology, immunohistochemistry, and stereology and be responsible for evaluating and integrating findings from specialty toxicology studies or specialty portions of such studies
  • Function as a peer review pathologist and/or participate in a pathology-working group (PWG)
  • Serve as a collaborative consultant in pathology-related issues
  • Work directly on a routine and consistent basis with Federal investigators to help ensure study success and client satisfaction
  • Provide leadership as a key member (Associate Director) of the TPA-onsite management team with exceptional opportunities for continual organizational advancement

Minimum requirements:

  • DVM/VMD degree or equivalent Board certified by the American College of Veterinary Pathologists preferred
  • For non-board-certified individuals, more than 10 years’ experience in toxicologic pathology is required
  • Toxicologic and investigative pathology experience required
  • PhD (or equivalent) preferred with significant investigative toxicology and/or industry experience in discovery, translational research and nonclinical product safety assessment
  • DABT certification desirable
  • Proficiency in performance and interpretation of special pathology-based cellular and molecular-based technologies (IHC, ISH, LCM and digital image analyses)
  • Demonstrated problem-solving skills and sound creative scientific judgment to best answer difficult product-specific safety issues
  • Experience working under GLP regulations and guidelines is highly desirable
  • Equally comfortable working within a resource-rich collaborative research environment or independently
  • Demonstrated proficiency and willingness to become a key member (Associate Director) of the program management team

TPA is an equal opportunity employer. As an equal opportunity employer, we do not unlawfully discriminate against any applicant because of race, sex, gender, ethnicity, religion, creed, age, color, military/veteran status, genetic condition or information, sexual orientation, gender identity, national origin, ancestry, marital status, qualified physical or mental disability, transgender status, or any other legally protected class in accordance with federal, state and local laws.

For additional information and the latest updates from the Company, please visit www.TPAInc.biz.

Contact:
Dr. William Witt, DVM, PhD
Program Director, Senior Staff Pathologist
3900 NCTR Rd Jefferson, AR 72903
william.witt@fda.hhs.gov
870-543-7077

Apply online.

Seattle Genetics, Bothell, WA—Associate Director/ Director, Pathology

Posted:
Company: Seattle Genetics
Location: Bothell, Washington
Job Title: Associate Director/Director, Pathology

Summary

We are seeking an experienced anatomic pathologist with exceptional scientific curiosity, critical thinking, and self-motivation to join our team of nonclinical scientists. You will be part of a vibrant and skilled group leading the scientific understanding of the safety of novel therapeutics in a company dedicated to finding cures to cancer. Interpretation, integration, and assessment of significance of data in the context of multiple other scientific investigators both internally and externally are critical. You will be expected to review findings from nonclinical studies in support of clinical development and will have significant autonomy to propose and drive the investigative and mechanistic understanding of these toxicities. Your communication skills at all levels of interaction must be excellent. This is a pivotal role in the department reporting to the Executive Director of Nonclinical Sciences and you will be expected to contribute significantly to growing the pathology expertise within the department. In addition, you will serve as a nonclinical representative on project teams and may have opportunity to serve as a program lead on early projects.

Responsibilities

  • Foster continued development of the group’s regulatory pathology expertise through primary data generation on non-GLP and GLP studies, and peer review of external GLP studies
  • Assist in developing and delivering an overarching strategy for the delivery of anatomic pathology data, which may include internal resources and/or external partners
  • Provide internal expertise to understand the mechanisms of toxicity observed nonclinically and/or clinically in order to drive mitigation and/or back-up strategies to minimize potential harm to patients
  • Present data and interpretations in written and oral form to regulatory bodies to enable optimal clinical development and registration of novel drugs
  • Build collaborative networks internal and external to the company to ensure rapid communication and cross-functional evaluation and investigation of emerging safety issues
  • Aid in the development of a forward-facing vision of the non-clinical sciences department, and support implementation of this vision
  • Act as a nonclinical team representative responsible for the non-clinical safety strategy of novel target/therapeutic candidates. Your ability to understand the toxicity of the platform versus target related toxicities is key
  • Develop strong knowledge of the basic biology of the intended target of drug candidates
  • Represent Seattle Genetics in the external scientific environment—influencing partners and regulators in a positive way

Qualifications

  • 10 to 12 years of toxicologic pathology experience in a contract research organization and/or pharmaceutical/biotech setting, reading slides, interpreting data, generating reports and regulatory documents
  • Experience in nonclinical safety assessment from discovery through development, especially with biologics
  • Proven success in scientific investigation of fundamental pathology issues, either through scientific publications or drug development experience

Education

  • DVM (or equivalent)
  • PhD in toxicology, pathology, comparative biology, or a related field
  • Diplomate, American College of Veterinary Pathologists (or equivalent) in anatomic pathology

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

Apply online.

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