Principal Scientist, Translational Science

Location
92121, San Diego
Posted
Sep 28, 2021
Hotbed
NextGen Bio
Required Education
Doctorate/PHD/MD
Position Type
Full time

Position Summary:

Reporting to the VP, Early Development & Program Management, the Principal Scientist, Translational Science will be the translational program lead, responsible for development and clinical application of product-related assays for Artiva’s late preclinical and clinical programs. This position will be responsible for the design, development, and optimization of pharmacokinetic, pharmacodynamic, predictive, and prognostic assays to define parameters associated with NK cell-mediated clinical response. Assays will be developed via contract research organization (CRO) or in collaboration with our research partners. The successful candidate will have strong cell therapeutic or immuno-oncology development history with demonstrated leadership in immunological assay development with NK and/or T-cells. A thorough understanding and application of flow cytometry and molecular/genomic techniques for studying immunological activity is a prerequisite for this position.

Key Responsibilities:

  • Lead the development of highly sensitive and specific assays for the detection and tracking of human allogeneic NK cells to study persistence in blood and tissue.
  • Lead the development of immune activity assays for assessment of pharmacodynamic response to cell therapies, including immune cell activation and cytokine upregulation.
  • Implement clinical assays that lead to identification of predictive and prognostic biomarkers associated with clinical response.
  • Define potential intrinsic and acquired resistance mechanisms and develop assays to further understanding of these mechanisms to inform future clinical programs.
  • Manage CRO-driven programs for assay development, optimization and clinical sample analytics.
  • Evaluate new technologies and assays that will enhance understanding of the parameters associated with clinical response.
  • Collaborate with clinical staff for patient sample acquisition, tracking and testing.
  • Draft, optimize and implement SOPs supporting clinical sample analytics.
  • Draft relevant sections of CTDs to support IND filing, updates and maintenance.
  • Develop transparent relationships across the organization.

Qualifications:

  • Ph.D. in immunology, biology, or related discipline with 8 - 10 years of experience within the biotechnology or pharmaceutical industry.
  • Direct experience developing immunological, pharmacodynamic and pharmacokinetic assays for cell therapeutics and/or immuno-oncology assets.
  • Demonstrated knowledge of cell therapeutics, particularly T-cells and NK cells.
  • Proven ability to manage CRO-driven research and development programs.
  • Demonstrated experience in SOP development and regulatory document drafting.
  • Excellent communication skills, verbal and written.
  • Ability to interact effectively across boundaries using influence and relationship building skills.
  • Strong problem-solving capabilities with the ability to prioritize and make tradeoffs to achieve goals.
  • Strong understanding of the drug development and regulatory process.

Artiva is an equal opportunity employer.