Waltham, Massachusetts, United States
Clinical trial operational lead for biomarkers/companion diagnostics in oncology. Scope of responsibilities include: • Execution of biomarker and companion diagnostic development objectives in global clinical trials • Core clinical study team member • Business owner and third- party laboratory vendor oversight lead • Central lab management and oversight • Clinical study budget management and planning • High-performance team member, assigned to priority assets/registrational studies • Human biological sample management • Informed consent and clinical study protocol contributor Additional responsibilities/highlights • Precision medicine: solid tumor, heme oncology targeted therapy • Management of study and departmental objectives across a complex global matrix. • Lead departmental representative in global task force • Project lead/coordinator, co-departmental method development • Lead developer/author on several internal procedures and guidance • Excellent working relationships with key external diagnostic partners in Precision Medicine • China HGRAC regulations, including HGR exportation • Experienced in clinical trials, Ph1 -Ph3. Startup through closeout.
Primary contributor in clinical studies supporting product development, with focus on biomarker detection and quantification. Responsibilities include assay development, qualification/validation, operator training and supervision, sample testing, assay troubleshooting, and data reporting. Assay development and execution for various preclinical safety studies including cell based methods of immune prediction to support candidate selection, as well as in vitro cytokine release studies. Current platforms and technology include Proteinsimple ELLA, Luminex, MSD Quickplex, spectrophotometry/fluorimetry.
Supervision of the Clinical Specialty Laboratory: Clinical Trials and Adverse Events. Supervised multiple employees to support clinical trial and adverse event testing, troubleshooting, and data reporting in a clinical laboratory. Platforms included MSD Sector 2400, spectrophotometry, fluorimetry, and protein electrophoresis.
Lead Technologist and Subject Matter Expert in the clinical laboratory -Supervision of up to 2 employees, and the lead technologist in the laboratory. -Subject Matter Expert for multiple clinical trials and programs. -Elected by department head for Emerging Leadership management extended training program. -Trusted with a wide range of responsibilities, including authoring of bio-statistical reports, presentation of clinical data at annual Sanofi conferences, as well as assay troubleshooting, validation and reagent crossover support. -Experienced in ELISA, Chemiluminescence, RIP and Non Radiological IP, Fluorescence, SDS PAGE, Acid Dissociation ELISA, and automated techniques (Hamilton, Siemens, Bayer etc.). -Responsible for management and statistical analysis of data on a day to day basis for a very large clinical trial in a high volume CLIA certified laboratory. -Consistent production, reporting, and maintenance of patient data in accordance with standards established by CLIA and GcLP processes across multiple programs and platforms. -Representative of the Health Safety and Environmental committee. I am responsible for maintaining of safe work practices for, and communication to a department with more than 50 members. Further responsibilities include audit response for multiple laboratories, regular attendance to HSE meetings, and monthly updates provided to the entire department, as well as participation in cross-functional management when needed
-Per Diem position in addition to current full time position with Genzyme (Sanofi) -Primary responsibilities include Chemistry and Special Chemistry rotation -Operation of Siemens Vista, and Bayer Centaur
Laboratory Generalist: Hematology Microbiology Chemistry Immunohematology (blood bank)