|Title:||Senior Director, Biomarkers|
|Department:||Research and Development|
- Identify/assess key laboratory and IVD partners, and manage relationships with and ensure that deliverables are delivered on time and on budget to the agreed upon standard:
- Partner 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.
- Define analytical, clinical validation, and related regulatory requirements to develop verification expectations for preclinical and clinical biomarker testing.
- Ensure delivery of high quality biomarker sample handling and testing in Aevi clinical trials:
- Develop SOPS, manage and oversee the compliance of clinical biospecimen lifecycle management aligned to informed consent and sample retention timelines
- As the diagnostics superuser for electronic Quality Management System (eQMS), inform requirements and lead implementation and management of eQMS for diagnostic requirements requirements
- Contribute to the development and maintenance of SOPs guidance documents for biomarker and diagnostic activities.
- Co-lead regulatory resource(s) for filing of IDEs, 510ks or PMAs, as appropriate
- Explore, develop and implement new technologies for translation of biomarkers into clinical studies
- Establish preferred vendors: Identify and vet laboratory partners using platforms and technologies to support preclinical and clinical biomarker and diagnostic activities.
- Supervise, develop, and provide leadership to direct reports
- Bachelor’s degree in the life sciences or healthcare related field and at least 15 years industry experience in clinical trials and biospecimen management or Master’s degree and at least 10 years experience. The ideal candidate will also have 5 years companion diagnostic experience in the pharmaceutical industry.
- 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.
- 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.
- Extensive laboratory experience in R&D/clinical laboratory techniques involving various specimen types, including saliva, blood and tissue.
- Proven abilities in setting priorities, managing multiple projects, building processes and implementing complex/novel strategies in managing biospecimens.
- Experience in managing different partners (including laboratories and IVD companies), balancing multiple priorities and building relationships with strategic business partners.
- 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.
- Previous supervisory experience of diverse and/or matrix teams.