Senior Clinical Pathologist And Biomarker Strategist

Pfizer Pearl River , NY 10965

Posted 2 months ago

ROLE SUMMARY

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.

ROLE RESPONSIBILITIES

  • 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

BASIC QUALIFICATIONS

  • 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.

PREFERRED QUALIFICATIONS

  • Experience in developing nonclinical safety strategies and clinical pathology data interpretation in toxicological pathology and/or industry setting

  • Additional board certifications in Toxicology

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer 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. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Other Job Details:

  • Additional Location Information: Groton, CT, Cambridge, MA

  • Eligible for Relocation Package: yes

  • Eligible for Employee Referral

    Bonus:
    yes

N (Other) (United States of America)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


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Senior Clinical Pathologist And Biomarker Strategist

Pfizer