Job Abstract

Job Description

The Nonclinical Drug Safety department in West Point, PA is seeking a Toxicologist to conduct and/or monitor toxicity studies (GLP and non-GLP) as a Study Director or Study Monitor and to potentially serve as a departmental representative on a product development team.  Toxicologists at our Company are integral members and leaders of collaborative cross functional scientific teams, addressing challenges from early discovery to late development.  Our toxicologists provide scientific leadership in the design and overall conduct of in vivo studies and integrate the findings from all contributing scientists into reports that characterize the safety profile of drug candidates.

Key Responsibilities

• Serve as the single point of control (Study Director) on assigned acute through chronic general toxicology studies across all modalities.  Interact with technical, veterinary, and scientific staff to ensure that the study is in compliance with the protocol, amendments, Standard Operating Procedures, regulations, safety guidelines, and company policies and procedures.

• Critically analyze and interpret data. Integrate data from other areas (e.g., clinical pathology, pathology, toxicokinetics) in written reports used for regulatory submissions, and communicate results within established timelines.

• Participate on cross-functional group teams to investigate mechanisms of toxicity, utilizing additional tools and applications that are available on site.

• Potentially serve as a departmental representative on a product development team, overseeing the strategy and design of nonclinical safety studies and generation of regulatory strategies and communications with global regulatory agencies to support the development of drug candidates.Conduct nonclinical ophthalmic examinations (GLP and non-GLP) on a variety of species depending on experience and interest.

Education

• PhD and/or DVM with graduate and/or post-graduate work training in toxicology, pharmacology, or related scientific discipline

Requirements

• Minimum of 5 (five) years of relevant experience as a Toxicologist or Study Director in pharma, biotech, or at a CRO

• Demonstrated understanding of and experience with Good Laboratory Practices (US FDA 21 CFR Part 58)

• Strong interest in collaborating with diverse cross-functional teams and communicating openly and often with colleagues

• Strong listening and collaboration skills

• Ability to communicate clearly using verbal and written formats

Preferred

• Expertise in ophthalmic examinations or expertise/knowledge in ophthalmology (e.g., anatomy, pharmacology, or toxicology).  Training, as needed, in ophthalmic examinations would be provided

• Familiarity with outsourced study monitoring

• Experience serving as a representative on a product development team

• Background in veterinary medicine or experience working with laboratory animals

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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