Senior Director, Biomarkers & Diagnostics

Northeast
4623
Our client is a biotechnology company. They have asked us to assist them in a search for a Senior Director, Biomarkers & Diagnostics.  

Major tasks and responsibilities include:
  • Is responsible for identifying/assessing key laboratory and IVD partners, and managing relationships with and ensuring that deliverables are delivered on time and on budget to the agreed upon standard.
  • Partners with Clinical Operations and CHOP/CAG Scientists in generating well-defined and logistically feasible biomarker plans for study protocols with alignment to informed consent documents and case report forms.
  • Defines analytical, clinical validation, and related regulatory requirements to develop verification expectations for preclinical and clinical biomarker testing.
  • Ensures delivery of high-quality biomarker sample handling and testing in the company’s clinical trials.
  • Develops SOPS, manages and oversees the compliance of clinical biospecimen lifecycle management aligned to informed consent and sample retention timelines.
  • Contributes to the development and maintenance of SOPs guidance documents for biomarker and diagnostic activities.
  • Co-leads regulatory resource(s) for filing of IDEs, 510ks or PMAs, as appropriate.
  • Explores, develops and implements new technologies for translation of biomarkers into clinical studies.
  • Establishes preferred vendors: Identifying and vetting laboratory partners using platforms and technologies to support preclinical and clinical biomarker and diagnostic activities.
  • Supervises, develops, and provides leadership to direct reports.
 
We seek candidates with the following qualifications:
  • A PhD in the life sciences or healthcare related field is required.
  • Must have at least 15 years of industry experience in clinical trials and biospecimen management (or a Master’s degree and at least 10 years of experience).
  • 5 years of companion diagnostic experience in the pharmaceutical industry is preferred.
  • Requires an ability to apply scientific and technical expertise to biomarker research in clinical trials in an industry setting with an understanding of current IVD technologies and techniques.
  • Must have sponsor-side clinical trial experience in handling multiple complex Ph1-3 clinical trials with emphasis on operational, regulatory and ethical aspects of biospecimen collection and banking.
  • Experience in developing biomarker sampling plans, working with biomarker data management plans and overseeing biospecimen logistics at vendor and clinical sites is required.
  • Must have extensive laboratory experience in R&D/clinical laboratory techniques involving various specimen types, including saliva, blood and tissue.
  • Requires proven abilities in setting priorities, managing multiple projects, building processes and implementing complex/novel strategies in managing biospecimens.
  • Must have experience in managing different partners (including laboratories and IVD companies), balancing multiple priorities and building relationships with strategic business partners.
  • Must have a solid understanding of project management principles with proven ability to provide deliverables on time, manage timelines and provide issue resolution.
  • Outstanding leadership, communication, team building and influencing skills with the ability to work in a multifunctional team environment, interact with a wide variety of internal and external customers and relate effectively to individuals at all levels of the organization is required.
  • Previous supervisory experience of diverse and/or matrix teams is required.
   
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

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