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Associate Director, Clinical Diagnostics

Pfizer
Pfizer
2+ years
$131,200.00 to $218,600.00
10 Dec. 26, 2024
Job Description
Job Type: Full Time Education: MD/PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

The Associate Director, Clinical Diagnostics at Pfizer will play a pivotal role in the development and implementation of diagnostic strategies to support the global development and commercialization of therapies, particularly in the context of personalized medicine. This position requires a leader with deep expertise in diagnostic technologies and a strong understanding of biomarker testing in clinical trials.

Key Responsibilities:

  1. Lead Diagnostic Strategy Development:

    • Develop and implement diagnostic strategies for various therapeutic areas or individual projects.
    • Collaborate with asset teams to ensure the timely testing of clinical trial samples, analyze, and report data.
  2. Expertise in Biomarker Testing:

    • Serve as a subject matter expert in cutting-edge diagnostic technologies, including NGS, PCR, flow cytometry, and immuno-assays.
    • Integrate clinical assays or In Vitro Diagnostics (IVDs) into clinical trials, including authoring protocol sections, lab manuals, and informed consent forms.
  3. Partner and Regulatory Collaboration:

    • Manage partnerships with IVD providers through the development, validation, and approval processes.
    • Support regulatory and commercial planning for the approval and launch of diagnostic tests.
  4. Cross-functional Leadership:

    • Lead and influence teams, providing technical leadership and ensuring effective execution of diagnostic strategies.
    • Communicate complex scientific and business issues clearly to stakeholders and project teams.

Requirements:

  • Educational Qualifications:

    • PhD, MD, or MD/PhD in a relevant field (e.g., pathology, immunology, oncology, molecular biology, genetics).
  • Experience:

    • Experience in companion diagnostics, biologic therapeutics, biomarker assay development, and clinical trial execution.
    • Expertise in the IUO (Investigational Use Only) development and validation of molecular tests, immuno-assays, and/or flow cytometry.
  • Skills:

    • Strong understanding of translational approaches in clinical trial design, regulatory processes, and biomarker implementation.
    • Excellent communication and organizational skills, with the ability to lead and motivate teams to reach solutions and drive outcomes.
  • Leadership:

    • Ability to collaborate, influence, and guide peers and teams in a fast-paced, scientific environment.

Additional Job Details:

  • Salary Range: $131,200 to $218,600 annually, with a bonus target of 17.5% of base salary.
  • Benefits: Includes 401(k) with Pfizer Matching Contributions, health benefits (medical, dental, vision), paid time off, caregiver/parental leave, and more.
  • Relocation Assistance: Available based on business needs and eligibility.
  • Work Authorization: Permanent work authorization in the U.S. is required.

Sunshine Act Compliance:

Pfizer reports payments and transfers of value to healthcare providers under federal and state transparency laws. This includes any reimbursement of recruiting expenses for licensed physicians.

EEO & Employment Eligibility:

Pfizer is an equal opportunity employer and complies with all applicable national, state, and local laws regarding nondiscrimination and employment eligibility verification.

This role offers a unique opportunity for a leader to contribute to the development of groundbreaking diagnostics strategies in support of Pfizer’s therapeutic innovations. The position is ideal for someone with a strong scientific background and a passion for advancing personalized medicine through diagnostic technology.