Reporting to the Chief Development Officer, the Head of Translational Development will collaborate with Century’s Research, Development, and Manufacturing teams to harness the power of adult stem cells to develop curative therapies for cancer. They will be responsible for establishing and leading Century’s Translational Development group and defining the translational development and biomarker strategies for our hematology and oncology cell therapy programs. This leader will interpret and present these results, evaluate their associated clinical impact, and interact with partners and CROs to enable Century’s growing pipeline.
Responsibilities • Lead definition of translational development (biomarker) strategies for Century’s allogeneic cell therapy hematology and oncology clinical candidates, including choice of biomarkers that advance product and clinical development understanding and guide patient treatment • Assess and interpret translational, biomarker results and advise on the impact • Establish a translational development group including hiring and leading scientists • Collaborate closely within Century Research, Clinical, Data Sciences / Informatics, Non-clinical, Product and Process Development, Manufacturing, and Regulatory areas • Assess the utility and feasibility of candidate biomarkers; evaluate assay technology platforms to identify robust, timely and cost-effective biomarker assay solutions • Lead the establishment, evaluation, and implementation of clinical biomarker assays for cell therapies to assess pharmacokinetic, pharmacodynamic, cell-specific and disease-specific markers upon patient enrollment and treatment • Recommend, select, and lead collaborations with academic laboratories and vendors and CROs for biomarker assay choice, implementation, and execution • Design the biomarker and pharmacokinetics strategy for clinical trials, including prioritization of optimal biomarkers to be evaluated, determination of appropriate tissue samples, relevant time points, and sampling processes • Determine assay qualification approach and execution, including clinical sample logistics • Write translational sections of clinical trial protocols, reports, regulatory submissions, and serve as an expert in these interactions • Define, manage, and coordinate study workflows and budget for scientists and vendors
Qualifications • PhD in life sciences or medical sciences, and a minimum of 5 years of relevant biotechnology or pharmaceutical industry experience • 3-5 years’ experience guiding translational efforts including clinical biomarker assay development, qualification, validation, and execution of translational studies during hematology and oncology clinical trials • Outstanding working knowledge of immunology, cancer biology; hematologic and solid tumor diseases
Requirements • Robust knowledge of oncology clinical trial design, analysis and interpretation of biomarker data in preclinical and clinical settings, in conjunction with data science evaluations • Ability to author biomarker portion of clinical protocols and regulatory submissions • Relevant experience in GLP, assay validation methodologies and regulations that apply to clinical laboratory studies (including supporting regulatory submissions) is required • Direct evidence of collaborative practice and mindset • Expertise leveraging biomedical research methodologies and state-of-the-art genetic analysis technologies
About Century Therapeutics, LLC:
Century Therapeutics is developing novel allogeneic living cell products for oncology that overcome the limitations of first-generation cell therapies. Our genetically-engineered, universal iPSCs-derived immune effector cell products (NK, T, Dendritic cells, and macrophages) are designed to specifically target hematologic and solid tumor cancers. Our commitment to developing off-the-shelf cell therapies will expand patient access and provides an unparalleled opportunity to advance the course of cancer care. https://www.centurytx.com/