Clinical pathologist and biomarker strategist (CPBS) is a global role that will function to support target and candidate confidence in rationale/mechanism and confidence in safety monitoring by providing comprehensive evaluation of biomarker strategies. The role will involve developing biomarker and translational strategies when safety issues arise or on strategic biomarker investments. The role will work across laboratory groups to connect, align and eliminate barriers to working as an integrated global unit in addition to be a mentor for biomarker strategists and other clinical pathologists. CPBS will also serve on project teams as Drug Safety Team Lead to work on nonclinical safety strategies and lead or participate on issue management teams to investigate mechanistic aspects or develop monitorability for safety findings. The role will also be the subject matter expert (SME) in reviewing regulatory dossiers and responding to health authority queries working closely with regulatory and portfolio groups. CPBS will also write clinical pathology narratives and review reports. Leadership in external influence such as within precompetitive consortia is within the scope of this role.
Develops and implements translational biomarker strategies by collaborating across DSRD, research units and partner lines (ECD, BMD)
Develop innovative scientific and strategic biomarker proposals by developing cross discipline partnerships to address prioritized safety attrition areas.
Provides DSRD Biomarker leadership on project teams and relevant issues management teams to provide scientific guidance on nonclinical and clinical biomarker strategies
Leadership in DSRD portfolio activities by representing biomarkers within therapeutic areas and translational review meetings within discovery and translational research groups.
Aligns across discipline lines (eg; Pathology, portfolio and General Toxicology) to provide comprehensive safety assessment and biomarker strategies
As Drug Safety Team lead, develop nonclinical strategies and provide expertise to asset teams related to nonclinical and clinical safety. Contribute to regulatory queries and dossiers.
Supports external influence by providing representation to external academic, consortium and industry biomarker efforts, which is important to continue to develop, validate, and implement new biomarkers and promote more effective drug development
Involved in the design and comprehensive evaluation of the clinical pathology endpoints in efficacy and safety (exploratory and regulatory) studies
Clinical pathologists that have expertise (board certification) and interest in anatomic pathology may also contribute to safety/efficacy assessment by microscopic examination of tissues
DVM/VMD degree or equivalent veterinary degree is required
Board certification in clinical pathology by the ACVP/ECVP or equivalent
Strong verbal and written communications skills are required.
PhD, MS or other advanced graduate degree in pathology or a related field.
Minimum of 10+ years' post-DVM/PhD residency experience in clinical pathology data interpretation in toxicologic pathology and/or industry setting.
Experience in leading biomarker strategy to address challenging questions using integrated methodologies is critical.
Ability to understand translational aspects, biomarker strategies, perform complex data analysis, integrating clinical signs and anatomic pathology findings to interpret clinical pathology data.
Experience in developing nonclinical safety strategies and clinical pathology data interpretation in toxicological pathology and/or industry setting
Additional board certifications in Toxicology
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Other Job Details:
Additional Location Information: Groton, CT, Cambridge, MA
Eligible for Relocation Package: yes
N (Other) (United States of America)
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