TOXICOLOGIST/ PATHOLOGIST (Must Be Board Certified)
Salary (162-240K)+ Bonus + Paid Relocation
Seeking a savvy, experienced, inquisitive toxicologic pathologist to join our Preclinical Safety organization for an exciting and challenging position that offers the opportunity to work in the disciplines of both regulatory and investigative toxicologic pathology. As a member of Preclinical Safety, the successful candidate will be part of an international team of accomplished scientists that works collaboratively to promote the interests of patient health and safety. The candidate will provide intellectual and strategic input to the discovery and development of therapeutic molecules from across the company’s pipeline, including a diverse array of biological modalities, and work collaboratively with multidisciplinary Research and Development teams to characterize toxicologic liabilities, advise on strategies to move forward intelligently, and advance therapeutics to registration successfully. The qualified applicant will possess strong scientific and regulatory knowledge in anatomic and clinical pathology, combined with the ability to delve into findings and propose investigative strategies to understand toxicologic mechanisms.
- Serve as a study pathologist on non-GLP exploratory toxicology studies and as a peer-review pathologist on GLP toxicology studies, integrating and interpreting the findings. Represent the company’s interests, maintain high ethical and scientific standards, and act confidently and with conviction.
- Work collaboratively to assist project team members to understand toxicologic and pharmacologic relevance and implication of study findings.
- Clearly communicate findings to project teams and Preclinical Safety management as necessary and provide advice on the program and clinical or regulatory strategy.
- Propose and devise investigative strategies to understand mechanisms of toxicity.
- Serve as a subject matter expert to assist in authoring of regulatory submission documents and addressing issues or queries from regulatory agencies, including proposing strategies for resolution.
- Serve as an active member of the global pathology advisory group at our company to review and interpret findings of uncertain or indistinct relevance.
- Provide scientific due diligence support for business development opportunities as required.
- Participate in relevant external consortia and symposia to keep current with industry trends and regulatory evolution in the pathology field. Represent the company’s interests, maintaining high ethical and scientific standards.
Requirements & Qualifications:
- DVM (or equivalent) and PhD in a relevant discipline with board certification in veterinary pathology.
- A minimum of 12 to 15 years of experience working in the pharmaceutical or biotechnology industry in the field of toxicologic pathology.
- Demonstrated ability to manage professional time and diverse responsibilities efficiently and equitably for the benefit of a diverse customer base.
- Strong scientific record with demonstrated high level of scientific discipline and knowledge and expertise as an experimental scientist; investigative toxicology experience will be especially valued.
- Demonstrated knowledge of GLP regulations and global regulatory requirements for nonclinical safety assessment of small and large molecule modalities to support clinical development and registration.
- Experience working with diverse biological modalities is a plus.
- Effective collaboration skills.
- Excellent verbal and written communication skills, including authorship of pathology reports and publications.