Senior Manager, Companion Diagnostics & Clinical Biomarkers

The Senior Manager, Companion Diagnostics and Clinical Biomarkers should possess a basic working knowledge and understanding of clinical biomarker development, the oncology therapeutic landscape, and the regulatory guidelines for companion diagnostic submissions. While the primary role of this position will focus on the development of assays for patient selection and pharmacodynamic response, this individual will also provide scientific and strategic input to support efficient decision making for our ongoing clinical trials. As a member of development project teams, as well as research and translational sub-teams, he/she will have the opportunity to work in a highly collaborative environment and to support projects throughout clinical development.

Responsibilities

  • Lead development of high-quality biomarker assays and/or companion diagnostics needed to advance the oncology pipeline by working closely with Global Development teams.
  • Participate in relevant Early and Late-Stage Development teams as well as clinical project teams to provide biomarker and diagnostic development expertise and evaluate the scientific basis and clinical applicability of companion diagnostic assays, including test validation and rigorous data analysis.
  • Provide guidance on the technical performance, operational excellence, and quality of biomarker assays and companion diagnostics, ensuring suitability for the stage of development.
  • Oversee the implementation of biomarker assays and analysis at external clinical diagnostics laboratories.
  • Collaborate with clinical and regulatory leads to author sections of regulatory filings, including Pre-Sub, Q-Sub, IDEs, risk assessments, and PMAs.
  • Participate in the selection of diagnostics with external partners and manage relationships with key alliance partners, external consultants, and service providers to ensure the timely delivery of high-quality companion diagnostics required for successful regulatory approval and commercialization.
  • Evaluate diagnostics methods and providers, including existing commercial assays as well as novel and disruptive diagnostics technologies.
  • Perform other duties as assigned.

Qualifications 

  • MS or PhD in a relevant scientific discipline, or MD, required, with an understanding of biomarker assay development and relevant work experience in a biotech/pharma role developing biomarker assays.
  • Technical understanding of methodologies such as in situ hybridization, immunohistochemistry, IHC multiplexing, fluorescence applications, use of image analysis algorithms, laser capture microdissection, RNAseq, qPCR, CISH, ELISA etc.
  • Experience drafting and reviewing regulatory documents (e.g., Pre-Sub, IDE, Q-Sub, PMA) as well as clinical documents (e.g., protocol, lab manual, IB) preferred.
  • Excellent verbal and written communication and presentation skills.
  • Able to work in fast paced work environment and lead cross-functional teams.
  • Outstanding relationship-building and communication skills, including proven ability to drive projects forward with external partners to meet aggressive clinical timelines.
  • Qualifications

 

Job Location: Remote

Equal Opportunity Employer

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