American College of Toxicology

SITE MAP
About ACT
Meetings & Courses
Journal
Good Stuff
Members



= Members Only

Employment Opportunities

As a service to employers and members, ACT posts job opportunities in toxicology. The listing cost is $250 and the announcement remains for six months or until you ask us for removal. Please send employment opportunity announcements to ACT Headquarters.

Current Positions

 



Principal Scientist, Toxicology

Company Name: Moderna
Location: Cambridge, MA
Reports to: Director, Toxicology

Posted: October 16, 2019

The Principal Scientist will lead all aspects of toxicology work for select nonclinical programs to enable drug candidates from research through development and IND enabling studies. The principal scientist will design, execute, and interpret nonclinical safety studies conducted in multiple species, and will be heavily involved in regulatory submissions and interactions with various health authorities as well as the internal clinical team. The successful candidate must have the ability to multitask and to function effectively in a fast-paced environment. Be capable of conducting work independently, but also capable of pulling in subject matter experts when necessary to lead the conversation. Will maintain extensive scientific awareness and presence in toxicology, publishes manuscripts and posters, presents at scientific conferences and other scientific forums. Engages with consultants and advisors in the field, as well as the scientific community at large.

Here’s What You’ll Do:

  • In conjunction with program teams and the nonclinical sciences team, develop toxicology strategies and provide expert support to research and development projects
  • Collaborate on the design of non-GLP investigative and pharmacology studies to support development compounds, as needed
  • Review, summarize and integrate complex data sets across multiple disciplines
  • Manage the preparation and presentation of nonclinical safety data for project teams, portfolio management, internal /external partners and/or scientific groups
  • Provide strategic advice to project teams and senior management including evaluation of conclusions and potential impact of toxicology results on program and clinical/regulatory strategy
  • Lead finalization of toxicology reports and manage the tabular presentation of data in accordance with CTD format
  • Support the preparation of national and international regulatory submissions and interactions with health authorities and be capable of effective communications with regulatory authorities
  • Interact cross functionally with Research, Regulatory, Clinical and Manufacturing
  • Work closely with clinical to ensure toxicology support for clinical trial designs
  • Mentor junior members of the team by providing scientific input and leading by example
  • The qualified candidate will serve as a resource for the department and project teams, proactively keeping colleagues/leadership updated with industry trends.

What You’ll Bring to the Table:

  • Doctorate degree & 5–10 years of scientific experience OR Master’s degree & 8–10 years of scientific experience OR Bachelor’s degree & 10–15 years of scientific experience in preclinical toxicology and drug development in the pharmaceutical/biotechnology sector
  • Familiarity with GLP regulations and ICH/FDA guidelines for the conduct of toxicology studies to support regulatory filings
  • Experience working with Contract Research Organizations
  • Ability to develop and deliver clear and concise presentations for both internal and external meetings
  • Outstanding written and verbal communication skills
  • Ability to multi-task and change quickly change priorities

Why Join Moderna?

At Moderna, we believe messenger RNA, or mRNA, is the “software of life.” Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Massachusetts, Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science’s list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com.

For more information please email Angela Grady at angela.grady@modernatx.com.

Back to Top


Non-Clinical Reviewer

Company Name: US FDA, CDER, OND
Location: Silver Spring, MD

Posted: October 14, 2019

Job Description:

Are you making a difference contributing to the public health and well-being of millions of Americans? Would you like to? The physicians, scientists and other dedicated professionals at the U.S. Food & Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) located in Silver Spring, MD, contribute to the public health of millions of Americans every day. We pride ourselves on our dedicated and skilled staff and are always looking for committed individuals to help us achieve our mission.

CDER is responsible for regulating prescription drugs, including new drugs, generic drugs, biological products and biosimilars as well as over-the-counter drugs. CDER’s drug regulatory responsibilities include premarket review of new drugs and generic drugs; maintenance of the OTC drug monograph system; monitoring of all marketed drug safety and promotional activities; review, monitoring and enforcement of drug quality during the entire drug life cycle; and ensuring drug products in the market comply with the law. OND’s public health mission is to protect and enhance the health of the public through the review and evaluation of scientific data submitted by pharmaceutical manufactures in support of New Drug and Investigational New Drug applications (NDA/IND), and to determine if candidate drugs are safe and effective. OND is seeking scientists to serve as nonclinical reviewer’s in various drug review divisions.

The nonclinical reviewer is responsible for reviewing and evaluating the results of nonclinical pharmacologic, toxicologic, and pharmacokinetic studies submitted in support of INDs, NDAs, and BLAs; these studies assess drug safety based on studies conducted by the drug developer. Review of the nonclinical pharmacologic and toxicologic data includes evaluation of the quality and adequacy of the various assessments and studies. These reviews serve as the basis for calculating initial safe starting doses in clinical trials, doses for longer duration clinical trials, and for product labeling (the package insert). Nonclinical reviewers prepare a comprehensive review of the data and submit recommendations and conclusions for consideration of the review team. As a nonclinical reviewer, you will have the opportunity to:

  • Advance the public health through new drug development;
  • Experience teaching and training opportunities;
  • Interact with pharmaceutical companies; and
  • Work with a wide range of scientific disciplines in a team-oriented atmosphere.

Salary & Benefits:

  • Civil service salary at the GS-13 level
  • Excellent federal government benefits package (health insurance, life insurance, retirement, etc.).
  • Relocation expenses and student loan repayment may be paid to eligible candidates.
  • Flexible and/or partial telework schedules available (after completion of initial training period).

Qualifications:

Applicants must have a doctorate degree in pharmacology, toxicology, or a related field from an accredited university. Foreign graduates must have their transcripts and degrees evaluated by a credential evaluation service that is recognized by the National Association of Credential Evaluation Services (NACES) or the Association of International Credentials Evaluators (AICE). Candidates must be U.S. citizens. Permanent U.S. residents may apply for staff fellowship appointments.

To Apply:

Please send a current CV/resume and cover letter to ond-employment@fda.hhs.gov for consideration. Please reference Source Code: #20-033EG in the subject line.

FDA is an Equal Opportunity Employer with a smoke free environment.

Back to Top


Vice President, Pharmacology & Toxicology

Company Name: AnaptysBio
Location: San Diego, CA

Posted: October 09, 2019

This position leads a team in executing early clinical drug development activities evaluating the pharmacology and toxicology of antibody therapeutics focused primarily, but not exclusively, on immune-inflammatory diseases. As a key member of the development team, this role liaises with Discovery Project Team Leaders. The VP, Pharmacology &Toxicologyserve as a Development project team leader, where appropriate, and work collaboratively with the executive management to develop of key program stratgies, and strengthen the capabilities of the company.

This postion reports to the Chief Medical Officer.

Primary Responsibilities

  • Crafts the pre-clinical and clinical pharmacological strategies, including dose escalation, contributing to stopping rules, and risk-benefit to ascertain that compounds are entered into man safely, efficiently and with scientific validity.
  • Oversees the development and validation of quantitative in vivo assays to enable pharmacological characterization of therapeutic antibodies
  • Establishes collaboration with CROs andor academic institutions to develop in vivo pharmacology models to permit progression into the clinic of therapeutic antibodies
  • Provides strategic and tactical direction to multiple project teams
  • Prepares study reports for regulatory submission on development candidates
  • Contributes to new project ideas and in vivo proof-of-concept studies to enable the initiation of new antibody projects
  • Leads the Development project team and oversee the transition from discovery to clinical development of new antibodies

Qualifications

Education & Experience

  • PhD in Pharmacology or related science with a minimum of 15 years’ experience in a drug-discovery setting of a biopharmaceutical company, accompanied by at least 5 years of proven leadership experience.
  • Extensive experience in developing quantitative in vivo pharmacodynamic assays and preclinical disease models to assess target engagement and efficacy in a range of inflammatory/autoimmune conditions
  • Proven track record of making major contributions to the discovery of one or more marketed or in-development medicines
  • Prior experience of working across diverse therapeutic areas is highly desirable.
  • Proven managerial competence with previous experience in directly managing teams

Knowledge

  • Direct experience and knowledge of all the requirements (pharmacokinetics, toxicology, formulation etc.) needed to progress to first-in-human studies and different stage of clincal development
  • Sound theoretical and experimental background in biology coupled with a solid foundation in quantitative pharmacology
  • Ability to perform randomized controlled clinical trial principles, methodology and procedures.
  • Skilled at statistical data collection, editing, validation and analysis techniques.

For more information and to apply, visit our website:
https://recruiting.paylocity.com/recruiting/jobs/Details/172326/ANAPTYSBIO-INC/VP-Pharmacology-Toxicology

Back to Top


Executive Director, Pre-clinical Development

Company Name: Zogenix Inc.
Department: Nonclinical Development
Reports To: Vice President, Development
Position Type: Full-time / Regular / Exempt

Posted: September 17, 2019

Position Summary:

The Executive Director of Pre-clinical Development is a senior-level toxicologist who will oversee the nonclinical strategy and execution needed to rapidly progress drug candidates from preclinical development through clinical trials, regulatory approval and post-marketing. Responsibilities include oversight of toxicology studies, including design, monitoring, data analysis and reporting. The role will also be responsible for the content of nonclinical regulatory submissions, conducting the due diligence process on potential new development candidates as well as overseeing studies to de-risk early clinical development. The Translational Research group will report directly to this role.

Areas of Responsibility

  • Develop nonclinical pharmacology, ADME and toxicology strategy for 505(b)(1) and 505(b)(2) programs, working closely with cross-functional program teams and senior management
  • Oversee budget, contracts, and activities in the areas of nonclinical toxicology, pharmacology, and ADME.
  • Oversee completion of nonclinical sections of world-wide regulatory documents and reports, working closely with Regulatory Affairs.
  • Interact with US, European and Japanese regulatory authorities
  • Complete technical assessment of potential programs with Business Development
  • Work closely with other functional areas and colleagues to ensure that all studies are performed in a quality, timely and scientific manner
  • Provide strategic nonclinical toxicology expertise to cross-functional project teams as the nonclinical representative
  • Engage with colleagues across Zogenix to make decisions regarding translation from nonclinical to clinical program
  • Work with the translational research group to align research priorities with Company’s strategic goals
  • Work with Medical Affairs and Translational research on publication activities related to nonclinical and mechanism of action studies
  • Maintain current understanding of scientific literature related to specific projects

Minimum Job Qualifications

  • Minimum of 15 years industrial experience in nonclinical product development including experience managing a team
  • PhD or relevant doctoral degree in Toxicology, Pharmacology or a related discipline. DABT certification a plus
  • In depth expertise in developing nonclinical toxicology, pharmacology, and ADME programs for the 505(b)(1) and the 505(b)(2) regulatory pathways as well as post-marketing studies.
  • Experience managing cross-functional groups required
  • Experience in CNS, orphan-indication product development and/or modeling human disease, preferred
  • Knowledge of current GLP regulations, ICH and other regulatory requirements in US, Europe and Japan
  • Strong scientific research background
  • Self-motivated individual with the ability to think and work independently
  • Demonstrated success and experience working in a complex drug development environment
  • Excellent communication skills with ability to clearly express themselves both verbally and in writing
  • Strong understanding of ICH, FDA and EMEA guidelines especially pertaining to preclinical / nonclinical product development. Engagement with industry group(s) to keep abreast of changes in toxicology, DMPK and safety pharmacology guidelines a plus.

Preferred Job Qualifications

  • Demonstrated success working effectively outside defined scope of responsibility, when required.
  • Have a bias for action and display a sense of urgency.
  • Possess strong skills in leadership, communication, project management and budget management while maintaining high quality and efficiency standards.

Special Working Conditions

  • Up to 5-10% travel required

Back to Top


Associate Director, Global Nonclinical Regulatory

Company Name: Eisai

Posted: September 03, 2019

Eisai's Associate Director, Global Nonclinical Regulatory position reports to the Executive Director, Global Nonclinical Regulatory, and provides overall nonclinical strategic advice for product development and collaborates with colleagues in Global Drug Safety (GDS) to ensure nonclinical safety assessment programs for pipeline candidates meet evolving global regulatory standards.

This person advises management and recommends departmental operating procedures/policies to accomplish work more efficiently.

The Associate Director collaborates with colleagues in other functions in BA, MDC, and Business Groups to optimize information sharing and document preparation.

Essential Functions:

  1. Serving as eCTD Nonclinical Module Manager on assigned projects to ensure that high quality nonclinical sections of INDs/CTAs/NDAs/BLAs/MAAs are provided according to submission timelines.
  2. Leading the development of regulatory strategies to support the successful nonclinical development of pipeline products. Implementing strategies to identify, monitor, and resolve regulatory issues with moderate supervision.
  3. Partnering with colleagues in other functional units and business units to optimize the global submission process and to address nonclinical safety issues. Fostering discussion of emerging issues and information sharing between Regulatory, GDS, and Clinical functions. Collaborating with GDS colleagues to insure nonclinical safety assessment programs for pipeline candidates meet evolving regulatory expectations.
  4. Providing content and reviewing regulatory documents prior to submission, including annual reports, DSUR, PSUR, RMP, GIB and CCDS. Participating in formulating strategy and executing responses to nonclinical safety concerns from Health Authorities and draft nonclinical sections of briefing books as required. Participating in face-to-face meetings with Health Authorities to contribute to the strategy toward effective progress of the projects and obtain mutual agreements with the Authorities.
  5. Participating in initiatives to develop new Eisai policies that impact nonclinical regulatory affairs.
  6. Participating in nonclinical report finalization to insure that the regulatory impact of findings are appropriately recognized and communicated.
  7. Supporting Business Development in-licensing or out-licensing efforts.

Qualifications:

  • MS in Life Sciences required.
  • PhD or DABT (Diplomat American Board of Toxicology) preferred.
  • Minimum 8 years’ experience in the pharmaceutical industry, with a strong knowledge of regulatory toxicology.
  • Experience preparing nonclinical regulatory dossiers and interacting with appropriate health authority regulators.
  • In-depth knowledge of appropriate regulations and regional and international guidance documents relevant to nonclinical safety assessment.
  • Excellent communication skills, and the ability to build strong relationships in a highly matrixed organization.
  • Ability to think strategically, with an attention to detail.
  • Strong organizational and problem-solving skills

Here at Eisai, we are rewarded with highly competitive salaries, incentive awards, a comprehensive benefits package (Medical, Dental, Prescription and Vision Plans) 401k, Flexible Spending Accounts, Life and Disability Insurance, and other great programs.

Eisai is committed to a policy of equal employment opportunity for all employees and applicants. The Company also strives for a work environment free from discrimination and harassment. It is Eisai’s policy to comply with all applicable federal, state and local laws and regulations regarding nondiscrimination in employment and not to discriminate against any employee or applicant for employment on the basis of any protected status, including, but not limited to, race, color, national origin, religion, sex, age, disability, pregnancy, ancestry, creed, alienage or citizenship status, sexual orientation, gender identity and expression, marital status, military/veteran status, genetic information, or any other protected characteristic as established by law.

Eisai is an Equal Opportunity Employer – Minority / Female / Disability / Veteran

Candidates should apply by visiting Eisai Careers:
https://jobs.brassring.com/1033/ASP/TG/cim_jobdetail.asp?partnerid=25064&siteid=5015&Areq=4872BR

Back to Top


Project Toxicologist

Company Name: Global Blood Therapeutics

Posted: August 29, 2019

Position Summary:

Global Blood Therapeutics (GBT) is a clinical-stage biopharmaceutical company determined to discover, develop, and deliver innovative treatments that provide hope to underserved patient communities.

We are seeking for a toxicologist to lead safety strategies for small molecule discovery programs while interacting with research and development teams. This position reports to the Head of Toxicology.

Essential Duties and Responsibilities:

  • Serves as Project Toxicologist on project teams in Research
  • Develops candidate selection screening strategies, as well as designs, implements, and oversees screening studies at CROs
  • Collaborates with Research to develop critical pathways to select development candidates
  • Leads investigative toxicology studies as needed
  • Works closely with Toxicology Study Manager to ensure timely completion of nonclinical studies with attention to quality
  • Serves as Study Monitor as needed
  • Maintains awareness of current and emerging standard practices and guidelines in the field

Qualifications:

  • PhD or equivalent in toxicology, pharmacology, or related discipline, preferably with DABT certification
  • Experience in the pharmaceutical industry (minimum of 3 to 5 years)
  • Experience in drug discovery/discovery toxicology, managing small molecule drug candidates
  • Experience with predictive toxicology methods preferred
  • Ability to work with interdisciplinary teams
  • Excellent communication skills
  • Excellent organizational and time management skills
  • Experience with managing studies conducted at CROs

Fit with GBT culture:

  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity

NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.

If you are interested in applying, please visit https://www.gbt.com/careers/.

Back to Top


RD4/RD5 Toxicology Scientist, Human Food Safety

Company Name: Zoetis Veterinary Medicine Research and Development
Location: Kalamazoo, MI

Posted: July 11, 2019

Job Description:

Zoetis Veterinary Medicine Research and Development is looking for an enthusiastic colleague to join the Safety Sciences group located in Kalamazoo, MI for a challenging position. Zoetis is seeking a toxicologist to provide scientific support to the design and conduct of toxicology programs supporting the human food safety technical submissions for new animal drugs in livestock species.

The Toxicology Scientist (Senior Scientist/Principal Scientist) will:

  • Represent project teams as the toxicologist supporting human food safety for development candidate products.
  • Design toxicology programs and workstreams to achieve a human food safety toxicology package compliant with international Guidance.
  • Propose and gain concurrence with strategies to project teams and regulators.
  • Interpret and communicate data from well-designed studies to project teams and senior management.
  • Be knowledgeable of the multiple toxicology program components including chronic toxicology, genetic toxicology, development and reproductive toxicology and how they apply to animal health product development and approval across the world.
  • Collaborate with toxicologists, pathologists, biometricians, research scientists and consultants to elucidate toxicology findings of concern for research and development programs of products intended for livestock.
  • Prepare regulatory submission documents, including integrated summaries and expert reports for domestic and international regulatory authorities (US FDA CVM, EMA CVMP, etc.)
  • Address regulatory queries from national authorities on submissions through formal and informal meetings, documents, and other communications

Qualifications and Experience:

  • Post-graduate research (PhD) highly preferred. MS with 10 years in animal health industry considered.
  • American Board of Toxicology Certification favored. Newly boarded diplomates are encouraged to apply. Exceptions may be made for exceptional candidates with relevant industry experience.
  • Direct experience (>2 yrs.) as a Study Director from a comprehensive CRO desired. For example, experience in conducting and reporting GLP multiple dose toxicology studies (up to chronic) desired.
  • Excellent organizational and communication (verbal and written English) skills required.
  • Evidence of teamwork on multidisciplinary projects desired. Experience and comfort presenting to groups of peers and experts.
     

Full time | Regular | Colleague

Zoetis 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 or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at zoetiscolleagueservices@zoetis.com to request an accommodation. Zoetis 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 possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the US solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com.” In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

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

Back to Top


Senior Nonclinical Research Scientist

Company Name: Rho, Inc.
Location: Durham, NC

Posted: August 9, 2019

Overview:

We’re a full-service contract research organization with a 30+ year history of delivering one of the best customer experiences in the industry, and we’re looking for talented individuals who are as dedicated to customers, teams, and quality as we are.

Rho is currently looking for a Senior Nonclinical Research Scientist who will provide strategic and tactical leadership to projects and teams by developing viable and long-lasting solutions to cross-program, cross-functional, and organizational issues and initiatives.

Responsibilities:

  • Serves as Rho’s nonclinical product development expert, responsible for the full range of nonclinical product development activities and services required to support the integrated product development programs and regulatory submissions of Rho’s clients, including gap analyses, strategic planning, executing and reporting of nonclinical studies, and authorship and review of regulatory submissions
  • Leads the nonclinical/preclinical and related regulatory components of integrated product development programs
  • Provides leadership, guidance, and support to a team, program, or project of large scope, as well as to the Program Management discipline within the company
  • Mentors and advises staff in nonclinical product development by providing strategic and tactical guidance to team members, creating a strong sense of team unity and team identity, and providing regular and ongoing positive and corrective feedback to team members
  • Proactively identifies risks and critically analyzes problems affecting the programs
  • Develops contingency plans as needed
  • Facilitates achievement of strategic goals for a program
  • Monitors ongoing progress of key nonclinical deliverables against Global Integrated Product Development Plan goals, including the identification of potential risks and contingency plans
  • Ensures effective, accurate and timely communication of key issues and progress to the team and Sr. Management
  • Manages the nonclinical components of regulatory submissions projects including INDs, IMPDs, IDEs, NDAs, BLAs, MAAs, and PMAs or portions thereof and is comfortable with all requirements related to electronic submissions
  • Manages scope of work, budget, and timelines for external nonclinical vendors, including consultants, preclinical toxicology houses, laboratories, and other vendors as appropriate
  • Participates in the planning, preparation, and conduct of regulatory authority meetings, and leads nonclinical discussions with regulatory authorities as appropriate
  • Plans, conducts, and/or leads nonclinical facilities qualification assessments, audits, and mock inspections.
  • Participates in business development activities, including assisting in the identification and assessment of new opportunities, representing Rho at conferences and meetings, and conducting capture activities for anticipated proposals
  • Provides guidance and input to the budgets and business submissions of proposals
  • Mentors other technical leads in business development and proposal creation activities

 

Qualifications :

  • PhD in Toxicology or related Life Sciences field, or equivalent demonstration of analytical ability, and 8+ years of relevant nonclinical product development and regulatory experience (DABT certification is desirable)
  • Experience with FDA is required; experience with ex-US regulatory authorities (meetings, submissions, strategy) desired
  • Excellent written, verbal, and interpersonal communication skills and the ability to interact effectively with all levels both within and outside the company
  • Proven ability to establish credibility with professionals on program teams
  • Excellent regulatory intuition and project management acumen
  • Ability to understand and motivate others and build effective teams
  • Ability to proactively develop and foster constructive interactions among team members in order to address difficult situations, including resolving and negotiating conflicts or problems with tact, diplomacy, and composure
  • Excellent presentation and critical thinking skills
  • Ability to handle multiple projects and priorities with exceptional organizational and time management skills (both project and self)
  • Proficient in advanced techniques with relevant software: MS Project, Visio, Excel, PowerPoint, Word, etc. in addition to experience working within shared work environments
  • Ability to travel as needed
     

EOE. Veterans/Disabled

If you are interested in applying, visit www.rhoworld.com.

Back to Top


RD4/RD5 Toxicology Scientist, Human Food Safety

Company Name: Zoetis Veterinary Medicine Research and Development
Location: Kalamazoo, MI

Posted: July 11, 2019

Job Description:

Zoetis Veterinary Medicine Research and Development is looking for an enthusiastic colleague to join the Safety Sciences group located in Kalamazoo, MI for a challenging position. Zoetis is seeking a toxicologist to provide scientific support to the design and conduct of toxicology programs supporting the human food safety technical submissions for new animal drugs in livestock species.

The Toxicology Scientist (Senior Scientist/Principal Scientist) will:

  • Represent project teams as the toxicologist supporting human food safety for development candidate products.
  • Design toxicology programs and workstreams to achieve a human food safety toxicology package compliant with international Guidance.
  • Propose and gain concurrence with strategies to project teams and regulators.
  • Interpret and communicate data from well-designed studies to project teams and senior management.
  • Be knowledgeable of the multiple toxicology program components including chronic toxicology, genetic toxicology, development and reproductive toxicology and how they apply to animal health product development and approval across the world.
  • Collaborate with toxicologists, pathologists, biometricians, research scientists and consultants to elucidate toxicology findings of concern for research and development programs of products intended for livestock.
  • Prepare regulatory submission documents, including integrated summaries and expert reports for domestic and international regulatory authorities (US FDA CVM, EMA CVMP, etc.)
  • Address regulatory queries from national authorities on submissions through formal and informal meetings, documents, and other communications

Qualifications and Experience:

  • Post-graduate research (PhD) highly preferred. MS with 10 years in animal health industry considered.
  • American Board of Toxicology Certification favored. Newly boarded diplomates are encouraged to apply. Exceptions may be made for exceptional candidates with relevant industry experience.
  • Direct experience (>2 yrs.) as a Study Director from a comprehensive CRO desired. For example, experience in conducting and reporting GLP multiple dose toxicology studies (up to chronic) desired.
  • Excellent organizational and communication (verbal and written English) skills required.
  • Evidence of teamwork on multidisciplinary projects desired. Experience and comfort presenting to groups of peers and experts.
     

Full time | Regular | Colleague

Zoetis 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 or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at zoetiscolleagueservices@zoetis.com to request an accommodation. Zoetis 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 possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the US solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com.” In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

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

Back to Top


Editor-in-Chief at Environmental Health Perspectives

Company Name: National Institute of Environmental Health Sciences, National Institutes of Health, Department of Health and Human Services
Location: No relocation required

Posted: May 28, 2019

Primary Job Function: The EIC will be responsible for providing the high-level, strategic direction and leadership necessary to sustain and enhance EHP’s high standards and stature in the environmental health research community, consistent with the mission and vision of NIEHS. With editorial independence, the EIC will be accountable to NIEHS leadership and the broader scientific community for ensuring that all content published in EHP is innovative, of high quality and integrity, advances the state of environmental health knowledge, and promotes translation of knowledge into environmental health action. The EIC will have the authority to independently determine the scope of EHP and the types and spectrum of articles published in the journal, and will be responsible for ensuring the relevance, scientific quality, and balance of all EHP content across the broad field of environmental health sciences.

With consultation and support from professional operational and scientific editing teams, the EIC will instill and oversee EHP peer-review policies and practices to ensure an efficient, timely and high-quality review process. In addition, the EIC will strategically recruit and evaluate Associate Editors and volunteer Editorial Review Board members. As the face of EHP, the EIC will represent the journal to the global environmental health sciences community through strategic outreach activities, speaking engagements, and editorials.

How to Apply: Applicants are required to submit a current curriculum vitae, bibliography, vision statement and full contact details for three references to EICsearch@nih.gov. The applicant’s overall vision statement for the journal should include their views on the effective management of manuscript processing and peer review, and their ideas on how to best select, engage and manage associate editors and editorial board members. The ideal candidate will have a PhD, MD, or equivalent Doctoral degree in a field of biological or health sciences or a related scientific discipline and experience conducting original research related to environmental health sciences. The time per week required to successfully fulfil the duties of this position will be negotiated with the successful candidate. Compensation will be commensurate with the duties of an EIC of a top tier specialty journal. The incumbent will be subject to a background investigation and public financial disclosure requirements.

Applications will be accepted starting June 4th, 2019 until the position is filled. For more detailed information on this position, please see www.niehs.nih.gov/careers/jobs/ehp-editor-in-chief/. Specific questions regarding the recruitment may be directed to EICsearch@nih.gov.

Back to Top


Head of Toxicology

Company Name: Bill & Melinda Gates Medical Research Institute
Location: Cambridge, MA

Posted: May 13, 2019

The Bill & Melinda Gates Medical Research Institute (based in Cambridge, MA) is a non-profit biotech dedicated to accelerating the product development timeline for diseases that disproportionately affect the world’s poorest populations, including malaria, tuberculosis, and diarrheal diseases and a range of challenges in maternal and newborn health. Our focus is translational medicine, advancing novel drug and vaccine candidates from the laboratory into human studies. We work across multiple interventions and disease areas to increase the identification, selection, and optimization of novel drug and vaccine candidates, with the intention to transition viable candidates to late-stage development partners across the global health ecosystem.

The Position

Reporting to the Head of Translational Discovery, the Head of Toxicology will join a team responsible for driving progression of preclinical discovery projects to ensure the availability of a continuous for clinical development by the Gates MRI. The team works closely with scientists at the Bill & Melinda Gates Foundation as well as industry, academic and nonprofit partners to support the analysis and progression of a complex portfolio, with the goal of improving portfolio breadth, increasing the efficiency of decision making, and ensuring rigorous, decision-oriented experimentation. Members of the Discovery group also work closely with colleagues at the Gates MRI to initiate and progress projects on clinical stage assets to support further development and regulatory filings.

The Head of Toxicology will oversee nonclinical strategy and execution needed to progress candidates from preclinical development into clinical trials and to support later stages of development. Responsibilities include designing, directing and monitoring exploratory and GLP toxicology studies; analyzing and reporting data; and contributing to regulatory submissions. The portfolio includes a range of modalities (small molecules, biologics, vaccines, devices and diagnostics) and disease areas, placing a premium on the ability to ask fundamental questions, articulate testable hypotheses, and assemble and coordinate teams of expert collaborators and partners. The successful candidate will possess the depth of expertise to develop a broad nonclinical toxicology program. (S)he will be able to write clear and concise descriptions of experimental design, results and interpretation and will develop and optimize nonclinical in vitro and in vivo safety screening assays, establish fit for purpose preclinical models, and design and conduct hypothesis-driven studies to assist in understanding mechanisms of toxicity, making early pre-clinical strategic decisions around program/candidate prioritization, and de-risking early clinical development.

Qualifications

  • PhD in Toxicology or other relevant field with at least 8+ years of industry experience designing, conducting, monitoring and interpreting nonclinical toxicology/research studies.
  • Knowledge of GLP regulations, ICH, and other regulatory guidance documents, and experience in writing nonclinical sections of regulatory documents a must; experience in studying mechanisms of toxicity is highly desirable.
  • Demonstrated excellence in discovery project leadership and project/portfolio management.
  • Excellent organizational and communication skills required for extensive interactions with multiple collaborators and partners.
  • Equally comfortable with high level strategic analysis and “down-in-the-weeds” detail-oriented execution.
  • Experience in infectious disease is desirable, as is experience working with multiple classes of compounds (small molecules, biologics, vaccines).
  • Comfort with ambiguity and complexity required; must be open to change and able to work across multiple projects and therapeutic areas/modalities simultaneously.
  • Strong interpersonal skills with polish and presence; ability to influence others at all levels and lead in a highly matrixed organization.
  • Passionate, persistent and tenacious. Strong ability to prioritize and operate with a sense of urgency.
  • Sense of humor required.
  • Position will likely require frequent travel.
  • Certification by the American Board of Toxicology is desired.

Please email Jobs@gatesmri.org with “Head of Toxicology” in the subject line and attached a CV.

Back to Top


Senior Scientist II/III

Company Name: AbbVie
Location: North Chicago, IL

Posted: May 1, 2019

Primary Job Function:

This position is in the Toxicology line function within the Preclinical Safety group and will report to the Director, Associate Director or a Sr. Group leader in Toxicology. This role designs, conducts and reports non-GLP and GLP general toxicology studies in support of drug submissions to regulatory agencies, and requires demonstrated effective written and communication skills.

Core Job Responsibilities:

  • The primary responsibility of this job is to function as GLP Study Director for AbbVie internally conducted toxicology studies (90% of time) and external sponsor monitor for studies conducted at contract research organizations (< 10% of time).
  • As study director, the incumbent ensures the highest standards in quality and regulatory compliance are met in study conduct and reporting.
  • Accountable for all aspects of GLP report authorship, including writing and reviewing toxicology study reports and preparing assigned components of filing documents that support submissions to global regulatory agencies for drugs in development.
  • Serve as scientific expert for studies, during audits and on project teams, committees and other assignments. Accurately identify key scientific findings and effectively communicate findings in reports, presentations, and meetings.
  • Demonstrate the ability to resolve key project study and assumptions by effectively utilizing available information and technical expertise.

Position Accountability/Scope:

  • Responsible for all aspects of GLP compliance within assigned studies and related departmental activities. Design, conduct and report toxicology studies appropriate to overall development plans and aligned with regulatory expectations.
  • Apply external scientific and regulatory information to development strategies and business practices.
  • The Toxicologist must design/critically evaluate and interpret experiments, record, tabulate and report results and significant issues. The Toxicologist must understand and follow established procedures and practices, ensure compliance with established procedures within the function, as well as possess a good understanding of appropriate FDA, ICH and OECD regulations and guidelines.

The level of this opportunity will be commensurate with experience.

Basic:

PhD or equivalent in Toxicology or closely related field, post-doctoral training and 2-3 years’ toxicology study director experience in pharmaceutical or contract research organization setting is a mandatory requirement.

Strong verbal and written communication skills to effectively communicate scientific data, issues and conclusions; work within small teams and in a matrix reporting structure environment; lead scientific issue identification and resolution.

Previous responsibility for GLP and non-GLP study conduct and project science within his/her area of expertise on one or more project teams. Demonstrates Toxicology expertise with agility, accountability and excellent communication skills.

Demonstrates the ability to resolve study design and regulatory issues and key project hurdles and assumptions by effectively utilizing available information and technical expertise.

Effective writer and communicator of research or other regulatory materials.

Proactively seek relevant information in the literature and incorporate this into knowledge of Toxicology practices and overall program issues.

Back to Top


Occupational Toxicologist

Company Name: AbbVie
Location: North Chicago, IL

Posted: May 1, 2019

Primary Job Function:

Supports functional goals by integrating toxicology information and data, health-based safety information and regulatory requirements for manufacturing safety into well-reasoned and supportable safety assessments and recommendations for AbbVie products. Generates new safety assessments that anticipate and critically evaluate scientific or regulatory advances.

Core Job Responsibilities:

  • Classify drug candidates and chemical intermediates into Performance –based Level of Exposure Control (PBLEC) bands and develop Employee Exposure limits (EELs).
  • Prepare Safety Data Sheets (SDSs) including classification of drug candidates, intermediates, and excipients pursuant to the Globally Harmonized System (GHS)
  • Monitor vendor-contracted worker safety testing studies.
  • Prepare product quality toxicology assessments to support non-conformances (e.g., extraneous matter assessments)
  • Provide risk assessment support for extractables and leachables for combination products, medical devices, container closure systems and manufacturing components
  • Prepare toxicology risk assessment to define permissible daily exposures (PDEs)/residual dose levels (RDLs) per EMA shared facilities guidance and RiskMaPP
  • Conduct literature searches, maintain AbbVie’s ToxInfo database, attend and participate in AbbVie’s Drug Handling Committee (ADHC) meetings.
  • Support other functions within the genetic, environmental and occupational toxicology organization such as providing toxicological evaluations for environmental toxicity and drug substance/drug product impurity risk assessments
  • Position accountability/Scope
  • The toxicology assessments and reports generated support health-hazard evaluations that can be used as a basis for decisions regarding product manufacture. The individual will maintain close communication with management and appropriate people across divisions

Basic Requirements:

  • MS degree with 2+ years of occupational toxicology experience, BS with 6+ years of occupational toxicology experience, or PhD with related experience.
  • Must have industrial Occupational toxicology or product safety evaluation experience
  • Proven ability to integrate safety data and develop health-based safety is preferred
  • Experience interacting with and advising cross-functional teams
  • Prior experience in preparing SDSs, establishing EELs, placing and evaluating toxicology studies is desirable
  • Must be detail-oriented and experienced with computerized databases, knowing how to search for and locate scientific literature. Must be able to summarize data and prepare reports and work independently with minimal guidance. Must be able to work in a fast paced environment to meet critical timelines.

Back to Top



















Join or Renew ACT membership
2019 Annual Meeting
ACT AM20
11190 Sunrise Valley Drive, Suite 300, Reston, Virginia 20191
Tel: 703.547.0875 | Fax: 703.438.3113 | Email: acthq@actox.org


Copyright © 2019 American College of Toxicology. All rights reserved.
You may view the ACT Privacy Policy, provide consent to ACT to email you communications, or unsubscribe to stop receiving further ACT communication. Privacy Policy | Provide Consent | Unsubscribe