Orchestrate and lead a collaborative planning process to define and execute the IVD assay strategy to support the Genetic Science Division Clinical Vertical's commercial business goals
This role will have responsibility for managing an IVDR instrument launch providing marketing input, identifying key portfolio/feature gaps, and prioritizing feature requirements in support of clinical molecular testing
As a key core team member of the core team, this role will interact with other departments including R&D, Manufacturing, Software, Global and Regional Marketing, Customer Support and Finance to ensure that products successfully enter into the market
Work closely with sub-teams to launch complex IVD products and programs which include systems, assays, instruments, and software
Partner with the R&D and product management peers to successfully define and execute new product and sustaining product plans
Drive new product introduction to completion by leading teams through the validation and regulatory submission phases of product development
Leverage technical expertise in MDx and regulatory strategy insights, bring new technologies and product concepts through uncharted regulatory paths
Launch instruments and assays to comply with the European Union In Vitro Diagnostic Regulation (IVDR), evolving into an expert who can efficiently usher new pipeline products through the design and development process
Define the IVD assay strategy for the Clinical Vertical's product portfolio and how it addresses ex-US markets
This person will work with the team to develop and execute program plans within cost and schedule constraints
Assigned projects may involve both internal development, partnerships with external collaborators or 3rd parties, and interaction with various regulatory bodies
Partner with Product Marketing and Business Development to incorporate regional considerations in portfolio decisions and go to market priorities
Ensure successful implementation of our go to market plans to accomplish customer adoption, use goals and financial objectives
Own the customer-driven process to define user workflow in different use settings
Drive successful relationships with key customers to ensure we understand emerging trends and successful adoption of new products
Provide technical marketing support to sales/support teams, training and tool development
Collect VOC from customers and internal stakeholders for customer requirements to the R&D team
Collaborate with the R&D development team to generate product requirements
Create test plans and protocols, and coordinate the creation of legal agreements
Proactively ensure that all members of the commercial team are engaged, incentivized and trained on the go to market IVD assays launch in conjunction with new platform launch
Participate in key industry forums, conferences & trade shows and customer visits to advocate for the clinical vertical's strategy and portfolio
Must have IVD product development experience in submitting and obtaining CE-IVD, and/or FDA 510k clearance
Strong working knowledge of IVD, design control, relevant regulations and be able to communicate with all levels in the organization
Work independently, in a collaborative environment, and be able to handle multiple projects in parallel
Previous experience in a product management role. Must have developed portfolio plans and led teams to execute the successful launch and ramp to volume of multiple products
Demonstrated ability to understand, synthesize and prioritize customer needs to inform and develop a competitive IVD assay strategy
Must have demonstrated track record of successfully building and leading teams.
Must have strong analytical skills and ability to tie detailed analysis to larger strategy
Must be willing to work in a fast paced, "matrixed" environment, managing multiple products that serve the needs of varying (and even overlapping) markets
Must be able to communicate requirements and negotiate priorities with both R&D and Software teams
Must possess exceptional communication skills (verbal, written, presentation) including the demonstrated ability to influence senior management about key decisions associated with portfolio, product and pricing decisions
Bachelor's degree or equivalent in Molecular Biology, Biochemistry or related fields, with strong preference for an advanced degree (MS or PhD), MBA strongly preferred
8+ years of industry experience with a phased gate product development methodology for life sciences.
Extensive experience developing and validating assays in LDT- and IVD-regulated environments, including successful interactions with the notified bodies in EMEA and/or FDA.
Hands-on, practical knowledge of requirements of working under design control required
Experience in Life Sciences, Genomics, or Pharmaceutical industries. Experience with molecular and/or DNA array technology is highly desirable.
Thermo Fisher Scientific Inc.