AffyImmune Therapeutics (“Affy”), a clinical stage biotechnology company focused on creating technologies that expand the utility and improve the safety of cell-based immunotherapy for cancer, is seeking an Associate Director, Clinical Biomarkers and CDx (Director, depending on experience) to develop and commercialize companion diagnostic (CDx) tests to support programs in various stages of development.

Passionate individuals who desire to have a direct impact on the strategy to deliver life-saving CAR T cellular medicines for patients with solid tumors will excel by lending their translational and/or clinical biomarker experience to this role.

Summary:

The Associate Director/Director of Clinical Biomarkers and CDx will be responsible for developing and implementing the clinical biomarker and CDx strategy and execution for clinical trial(s), as well as implementing the biomarker plan during clinical development in collaboration with the R&D team.

This individual will collaborate with R&D and Clinical Development on development of clinical biomarker plans and inclusion of clinical biomarkers in clinical studies, including study design, as well as design and execution of the CDx tests. The Associate Director/Director of Clinical Biomarkers and CDx will manage work with CROs/vendors and/or collaborate with colleagues from biomarker and CDx labs to ensure fit-for-purpose validation of clinical biomarker assays prior to implementation. The Associate Director/Director of Clinical Biomarkers and CDx will serve as a key member of project teams, providing expert input to teams and guiding clinical development of novel biomarkers.

Responsibilities:

  • Lead the clinical biomarker and CDx function to develop and deliver the biomarker and diagnostic strategies for all Affyimmune’s clinical programs.
  • Build and maintain biomarker plan.
  • Design, execute and analyze clinical biomarkers of target engagement, safety, pharmacodynamics, and efficacy.
  • Manage outsourced biomarkers assays at external vendors.
  • Coordinate between CRO/vendor assay development group and clinical team, when necessary.
  • Author relevant sections of clinical and regulatory documents.
  • Identify and work closely with CDx and clinical biomarker vendors and manufacturers to ensure delivery of high-quality CDx data packages as required for successful regulatory approval and commercialization of Affyimmune’s products.
  • Remain up to date on all regulatory, compliance, and relevant guidelines for CDx development and commercialization.
  • Function as an external scientific and business thought-leader to support business development, partnerships and communications.

Qualifications:

  • Ph.D. with 8+ years Biotechnology industry experience or Master’s degree with 12+ years Biotechnology industry experience required, including immuno-oncology, cell and gene therapies, and clinical trials.
  • Proven track record of high-impact contributions to clinical trial biomarkers and endpoints, and regulated assay development and validation in support of early and late phase clinical trials.
  • Understanding of the regulatory and commercialization requirements for CDx.
  • Experience with, at a minimum, immunohistochemistry, flow cytometry assays, molecular biology biomarker assays, and vector copy number (VCN) assays in a regulated setting.
  • Experience with authoring and reviewing SOPs and Validation documents in support of a regulatory filing or review.
  • Outstanding written and oral communication skills for clinical, business, and scientific audiences.
  • Strong sense of urgency and excellent skills in prioritization, planning, and execution in a very fast-paced environment.
  • Strong interpersonal skills and ability to thrive in a matrix environment.
  • Highly adept at solving complex, cross-functional problems.
  • Experience in managing external collaborations, contract laboratories, timelines, and budgets.
  • Demonstrated scientific capability as evidenced by publications, patents, research reports, and/or external presentations.
  • Effective verbal and written communication skills relating to colleagues and associates both inside and outside the company.
  • Flexibility to work on multiple projects as the portfolio evolves over time.
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