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Director, Diagnostics Lead

Company: Pfizer
Location: La Jolla
Posted on: April 18, 2019

Job Description:

ROLE SUMMARY

Diagnostics Lead provides expertise and front-line help to relevant Research, Early and Late Stage Development teams in non-Oncology for inclusion of Diagnostics in drug programs, provision and implementation of all relevant documents to such programs, and coordination of all downstream work, including life cycle management of diagnostics, within the Diagnostics Group as well as relevant internal- and external-facing organizations.

ROLE RESPONSIBILITIES:


  • Leads development of companion diagnostics programs by working closely with Research Units in R&D , and Global Product Development organizations
  • Serving on relevant Early Clinical Development teams and Study teams in Immunology & Inflammation, Internal Medicine and Rare Disease units, as a resource and authority to provide advice on inclusion of Diagnostics as appropriate
  • Accountable for timely implementation of Diagnostics plans in relevant project documents for such programs in, including but not limited to, late Pre-clinical through Early and Late-Stage Development
  • Accountable for timely delivery of high quality companion diagnostics required for successful regulatory approval and commercialization, including identification of external partners and program oversight
  • Accountable for the operational excellence and quality of companion diagnostics
  • Closely working with Diagnostics Operations Leads to ensure all lab manuals, sample requisition forms, CRFs and relevant Diagnostics SOPs are considered and oversight at testing facilities are provided
  • Serves as consultant in diagnostic development and commercialization including technical performance, timelines for development, regulatory, reimbursement, scale-up and commercialization of diagnostics
  • Partners with WWBD to assist in the selection of diagnostics external partners and to manage relationships with key alliance partners, external consultants and service providers
  • Evaluates diagnostics providers, commoditized as well as novel and disruptive diagnostics technologies
  • Other duties as assigned

    REQUIRED QUALIFICATIONS:

    • Degree in biomedical sciences with focus on genetics, molecular biology, clinical translational medicine, biomarker development or related field
    • 10+ years of relevant industry experience
    • Detailed understanding of in vitro diagnostics landscape and technologies
    • Working knowledge of diagnostic development regulations in USA, EU and other key regions

      PREFERRED QUALIFICATIONS:

      • Previous industry experience relevant to Diagnostics and/Companion Diagnostics
      • Working knowledge of IVD requirements including QSR compliance and Class 3 medical device regulations
      • Working level understanding of diagnostics platforms for in vitro diagnostics
      • Previous extensive hands-on experience with the development of diagnostic assays / products in a lab environment
      • Effective verbal and written communication skills to enable building of customer and colleague relationships both inside and outside the organization
      • Able to articulate clear and strategic goals with measurable metrics
      • Self-motivated, results oriented individual who is able to work with minimal supervision
      • Effective negotiation skills to reach agreements with a variety of interested parties internally and externally
      • Experience with Commercial, Medical and Regional customer-facing units
      • Team player who is able to articulate clear and strategic goals with measurable metrics

        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.

        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.

        Other Job Details:

        • Additional sites include: San Francisco, CA, NYC, Pearl River, NY and Cambridge, MA
        • Eligible for Relocation Package: yes
        • Eligible for Employee Referral Bonus: yes

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

Keywords: Pfizer, San Diego , Director, Diagnostics Lead, Executive , La Jolla, California

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