Head of Translational Medicine

Company Background

Catamaran Bio is developing novel, off-the-shelf CAR-NK cell therapies designed to treat a broad range of cancers, including solid tumors. Our proprietary capabilities enable us to harness the natural cancer-fighting properties of NK cells and enhance and tailor their effectiveness with the power of synthetic biology and innovative non-viral cell engineering. We are using our TAILWIND™ Platform, an integrated suite of technologies, to specifically address the end-to-end methods of engineering, processing and manufacturing NK cells and rapidly advance our pipeline of CAR-NK cell therapy programs. Catamaran is backed by leading financial and corporate investors, including SV Health Investors, Sofinnova Partners, Lightstone Ventures, Takeda Ventures and Astellas Venture Management.

Job Summary

Catamaran Bio is seeking a Head of Translational Medicine to build and lead our Translational Medicine team. They will be responsible for biomarker discovery, developing and implementing biomarker programs for clinical trials. They will work in concert with the preclinical, clinical and technical operations teams to develop and qualify assays, write protocols, manage samples and interpret results. The position reports to the Chief Medical Officer and will partner with the CMO and the clinical development organization to build, coach and mentor a dynamic clinical team. This team will encompass cross-functional leadership across our internal research and development and technical operations teams with external academic and industry partners. This role embraces the principles of a translational medicine mindset, with a focus on operational excellence and deep scientific rigor. The ideal candidate will have a passionate desire to help transform current treatment paradigms for cancer while working in an innovative and fast-paced small-company environment.

Job Responsibilities

  • Oversee the development and ensure the quality of pharmacokinetic, pharmacodynamic, pharmacogenomic and patient stratification and predictive biomarker assays to support the advancement of preclinical programs into the clinic
  • Oversee the development of in vitro diagnostics
  • Oversee the design and implementation of biomarker analysis in clinical trials, ensuring operational execution by partnering with biomarker CMOs and data management according to cGCP guidelines
  • Work with a cross functional team (medical directors, nonclinical and discovery research scientists, regulatory) to ensure early definition of, and agreement on biomarker strategy for clinical development and regulatory approvals.
  • Identify and work with KOLs and consultants to help define translation medicine plans
  • Work with technical operations on development of assays that will be used in common in the clinic and for product analysis and/or release
  • Represent Translational Medicine in cross-functional project teams
  • Serve as a bridge between research and clinical development
  • Partner with research, CMC and regulatory teams to drive existing programs to the clinic and provide clinical input into future pipeline and platform efforts
  • Maintain up-to-date knowledge of scientific and clinical published literature in oncology, tumor biology and the competitive landscape
  • Present clinical strategy rationale and decision making to senior leadership and investors
  • Develop and maintain budgets in collaboration with finance and program management

Education, Experience and Qualifications

  • MD or equivalent with minimum 10 years of relevant work experience, including a minimum of 5+ years in development of biomarkers and translational medicine strategies for oncology drug development 
  • Knowledge of biomarker development and implementation to support clinical assay development/validation for pharmacokinetics, mechanism of action, proof of biologic activity, patient stratification and response prediction markers for early, mid and late stage oncology clinical trials. Relevant skills include understanding of immunological techniques (flow cytometry, intracellular staining, cytotoxicity assays, ELISA, ELISpot, IHC, etc.), and molecular biology
  • Experience with the development of companion diagnostics
  • Strong background in cancer biology and immunology
  • Solid scientific understanding of the complexities and recent developments in cell therapy and the ability to apply knowledge to drug development
  • Good understanding of relevant areas of biology, biostatistics, regulatory, clinical pharmacology, pre-clinical toxicology, pharmacogenomics and biomarker-based approaches
  • Experience with academic research collaborations, budget, preclinical study designs, and early drug development (phase 1 and 2) are beneficial
  • Experience with contracting and overseeing external vendors, central laboratories and clinical research organizations to implement biomarker assay development and ensure execution excellence under cGCP/cGLP guidelines
  • Demonstrated organizational skills, aligning available resources to meet goals
  • Strong interpersonal skills and demonstrated ability to establishing effective collaborative relationships with internal stakeholders and external parties to ensure execution excellence