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Associate Director, Clinical Diagnostics

3+ years
$131,200.00 to $218,600.00
10 Dec. 27, 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

This job description is for the Associate Director, Clinical Diagnostics at Pfizer, a leadership role focused on developing and implementing diagnostic strategies across therapeutic areas, specifically in the context of global drug development and commercialization.

Key Responsibilities:

  1. Diagnostic Strategy Development:

    • Lead and execute diagnostic strategies for projects and/or therapeutic areas.
    • Serve as a subject matter expert in advanced biomarker testing technologies such as NGS (Next Generation Sequencing), PCR, flow cytometry, and immunoassays.
  2. Clinical Trials Integration:

    • Oversee the integration of clinical assays or in vitro diagnostics (IVDs) into clinical trials.
    • Author clinical protocols, lab manuals, and informed consent forms (ICFs).
    • Collaborate with Asset Teams to manage clinical trial sample testing and report associated data.
  3. IVD Partner Management:

    • Manage IVD partners during the development, validation, and approval phases of diagnostic tests.
  4. Regulatory & Commercial Planning:

    • Support regulatory efforts and commercial strategies for diagnostic test approval and launch activities.
  5. Leadership & Collaboration:

    • Lead and collaborate across teams to implement diagnostic strategies and ensure timely and efficient execution.
    • Influence and motivate colleagues to achieve meaningful outcomes and business impact.

Qualifications:

  • Must-Have:

    • PhD, MD, or MD/PhD with expertise in companion diagnostics or a related field (e.g., pathology, immunology, oncology, molecular biology, genetics).
    • Experience in biologic therapeutics, biomarker assay development, validation, and execution in clinical trials.
    • Extensive experience in biomarker selection and development of molecular-based tests, immunoassays, and/or flow cytometry.
    • Knowledge of translational approaches in clinical trial design, regulatory processes, proof-of-concept studies, and biomarker implementation.
    • Excellent communication, organizational, and leadership skills, with the ability to convey complex scientific issues and collaborate effectively.
  • Leadership Experience:

    • Proven ability to influence peers, coach others, and lead teams to achieve goals.
    • Experience in guiding and motivating colleagues to create a positive business impact.

Compensation & Benefits:

  • Salary: $131,200 to $218,600 annually.
  • Bonus: Eligible for a 17.5% performance-based bonus.
  • Equity: Participation in Pfizer’s share-based long-term incentive program.
  • Benefits: Includes 401(k) with Pfizer Matching Contributions, health benefits (medical, prescription, dental, vision), paid time off, caregiver/parental leave, and more.
  • Relocation: Assistance may be available based on business needs.

Application Details:

  • Location: Flexible, with some in-person requirements.
  • Sunshine Act: Pfizer complies with transparency laws and may report financial transfers related to recruitment.

This role is ideal for someone with a strong background in clinical diagnostics and biomarker strategy, along with leadership skills to drive the integration of diagnostic testing in clinical trials and support the development of therapeutic products.