The summary showcases the job seeker’s project management, budget strategy, and clinical testing experience.
The section below adds to the summary by identifying key skills, which is ideal for scanning by people or devices. This includes SNP Analysis, Molecular Cling, Plasmid Design Concepts and other BioPharma and scientific areas of expertise.
Reverse chronological professional experience starts with the current role. Statements below the heading identify the scope of the position.
Bullets are used to highlight major projects, strategies, infrastructure and achievements. Results are quantified when possible.
Education for this medical scientist is listed at the bottom of page 2 which includes a Ph.D in Microbiology and Immunology and a support bachelor of science degree.
Summary
- Dedicated Associate Director as BioPharma Project Management and Scientific Project Lead.
- Proficient in resource allocation and planning to support project deliverables, budget strategy, and managing clinical testing procedures from contract execution to close.
- Expansive knowledge of circulating tumor cells (CTCs), protein and genomic biomarkers, development of biomarker assay, and testing from feasibility through analytical validation.
Experience Statements
- Design, lead, and interpret data for assay and product development projects intended for RUO and clinical use (LDT) with ClearCell FX which is microfluidics-based system for enrichment of circulating tumor cells (CTC) from blood.
- Develop strategic map and plan for department which resulted in assay development completion of struggling assay and undergoing transfer to clinical lab for analytical validation and LDT offering.
- Create product portfolio from idea conception through execution which will be marketed and sold in over 23 countries through direct and distributor sales, including initiating, leading and executing collaborations, co-marketing deals, and OEM projects with other international technology companies.
- Identified gaps in technology workflow and filled gaps by initiating and leading co-marketing and OEM projects with other technology companies to expand product portfolio and technology workflows.
- Within 4-months of employment, set up and established US demonstration site in laboratory which served as interim site until US laboratory was set up.
- Built infrastructure of US office and developed process for commercialization by building workflows and processes such as opening demonstration laboratories, developing HR handbook, establishing processes for demonstrations, system for international shipments and inventory of instruments, and consumables. Collaborated with marketing and R&D teams to develop instrument and workflow guides, manuals, sales decks, and customer training curriculum.
- Collaborated with BioPharma partners to develop CTC biomarker strategies in three key areas including immuno-oncology (PD-L1), HRD-targeted therapies (i.e. PARP), and hormone therapy (i.e. AR-targeted therapy) for oncology therapeutic programs in various stages of clinical development (Phase I-III).
- Oversaw clinical trial testing to ensure CAP/CLIA compliance and delivery of project deliverable Performed data analysis, scientific interpretation of data, creation and delivery of scientific presentation to clients, generation of final reports, and study closeout procedures for studies ranging from clinical feasibility through late phase clinical trials related to CTC testing.
- Cross functionally worked with Assay Development, Marketing, IVD, Translational Research, Business Development, CLIA/CAP laboratory, and CTC classification team to maintain sample forecasting resources and project milestone updates to help ensure successful execution of Pharma contracts.