Global lead for immuno-oncology clinical biomarker strategy development and execution. Design, execute, interpret and report clinical biomarkers of target engagement, PD, efficacy and patient stratification to support global clinical trials.Contribute to clinical study protocols, regulatory documents and submissions.Serve as a leader and thought partner with preclinical and clinical teams to ensure alignment on translational strategies for programs that advance through the pipeline.Engage, evaluate, and establish relationships with third-party vendors to execute biomarker plans, accountable for biomarker assay transfer, development, validation and clinical sample testing and data reporting.Direct clinical biomarker operations. Clinical biomarker budget management.

Head of Translational Medicine.Worked in close alliance with the Research, Pharmaceutical Sciences & Manufacturing, and Clinical departments, developed and executed the translational biomarker, genomics and patient selection strategies across Genocea’s growing oncology portfolio.Lead the monitoring of patient-specific immune responses to vaccine antigens as well as the engraftment and durability of non-engineered cell therapy products.Oversaw translational assay development and adaptation into clinically acceptable formats with appropriate quality control standards in place.Directed clinical sample planning, logistics and chain-of-custody tracking.Responsible for clinical biomarker study outsourcing, CRO evaluation and contractingResponsible for translational data analysis, integration, and communication of results.Strategic oversight of translational medicine, including management of budgets, team growth, forecasting and scenario planning.

 Immunogenicity Sciences expert and representative for numerous therapeutic programs spanning immuno-oncology, immunology & inflammation, rare disease, biosimilar and generic at various stages of program development. Proven effectiveness and productivity collaborating with stake holders from cross-functional lines.  Founding member of the Immunogenicity Sciences group. Established wet lab infrastructure and capabilities for immune profiling and assessment of innate and adaptive human immune responses. Successfully led assay development, assay validation, process automation, data reporting standardization and portfolio project support for early product lead selection and evaluation of clinical assets.  Managed study outsourcing and partnership with external CROs, oversaw CRO study initiation, assay performance and results. Interfaced and cross-functional line strategies to address regulatory inquiries about immunogenicity of product CMC attributes. Key developer of predictive immunogenicity risk assessment concepts and strategies developing and owning of Pfizer official Immunogenicity Risk Assessment and Mitigation Plan (IRAMP) document templates respective to mAb, fusion protein, ADC, CART, Nanoparticle and Biosimilar programs.  Led TPIFG Pre-Existing Antibody Team comprising 14 members from 11 large pharma biotech companies. Delivered impactful publications, scientific events, and industry White Paper on pre-existing antibody assessment and management, industry surveys, 8 company- pre-existing Antibody ADA clinical data collection and statistical analysis, AAPS NBC symposium programming and other publications. Active member of AAPS Foreign Sequence Team and Immunogenicity Community.

 Principal investigator, bioanalytical representative and GLP supervisor for multiple therapeutic projects  Supervised or conducted PK and immunogenicity ligand binding assay development, assay validation, instrument validation and sample analysis for clinical studies. Oversaw bioanalytical data reporting, GLP documentation, SOP compliance, preparation and responses to QA audits. Led and conducted biotherapeutics immunogenicity response characterization, including ADA binding specificity, Ab isotyping, pre-existing Ab investigation and characterization using various assay platforms

Identification and functional characterization a novel voltage gated calcium channel in immune system.Systemically characterized roles that Cav3.1 played in lymphocytes development, transcriptional and functional regulation of Th1 Th2 lineage commitment in vitro and in vivo using SiRNA, gene knockout, and airway inflammation animal models.

Studied antigenic reactivity of oligo-clonally expanded T cells from the cerebrospinal fluid of multiple sclerosis patients.

In the prestigious immunology lab of Dr. Stuart Schlossman's. Identified direct structural and functional interaction of a novel CD27 associated protein with Bcl_XL.