Genomic Health is seeking a highly motivated and collaborative individual to lead the development of PCR or NGS-based products, in compliance with In Vitro Diagnostic Regulations (IVDR) in the EU and in anticipation of additional federal requirements for Laboratory Developed Tests (LDTs). This position plays a key leadership role in bringing new products and services to physicians which will help inform treatment decisions for patients with cancer. The IVD Product Development Director, will be directly responsible for providing product development regulatory guidance within a cross-functional team. The ideal candidate will be a strong leader and influencer with a proven track record in successful IVD product development.
The IVD Product Development Director will oversee the development of products to enable successful regulatory filings in Europe (IVDR) and possibly the US (510(k)/PMA) and provide IVD expertise and guidance to Product Teams, Business Development, and Senior Management. S/he will develop and manage the IVD Product Development Plan, working cross-functionally with various business functions.
The position will report to the Genomic Sciences Senior Director within the Research and Development organization.
- Direct, manage and conduct IVD product development activities under design control with a focus toward ISO, CE mark and IVDR submission.
- Member of product program Core Team with the following accountabilities:
- Define assay development and verification/validation strategy.
- Lead cross-functional activities in assay development from investigation through validation and commercialization.
- Collaborate closely with functional area leads and Core Team members, including Process Engineering Lead, Product Lifecycle Manager, Program Manager, Clinical Lead and Commercial Lead to transform strategy into action and execution.
- Direct liaison between the Core Team, Development Subteam(s) and Product & Services R&D functional group.
- Understand and communicate the external trends affecting the program, especially scientific and technological, to influence plans for growth, product iteration and integration.
- Develop external relationships.
- Lead Development Subteam(s) with the following accountabilities:
- Accountable for assay development and verification/validation under design control and transition from Development to Commercial Lab Operations.
- Accountable for meeting Development Subteam deliverables in line with budget and timeline.
- Identify needs of the Development Subteam(s) and partner with functional area groups for allocation of people and resources as required.
- Provide subject matter expertise for IVD product development including but not limited to; design control management and transfer process, device history management, change control, verification, validation, optimization testing and stability studies.
- Accountable for assay development documentation to support regulatory filings; accountable for abstracts and publications pertaining to assay development and validation.
- Ensure all development activities are conducted in adherence to applicable national/international regulations, guidelines, company policies, SOPs and industry standards.
- This is an individual contributor role performing in a team leadership capacity as a member of a Program Core Team and leader of relevant Development Sub-team(s).
- Other responsibilities as assigned.
- PhD degree in a life science plus more than 12 years of experience, including working in industry and within an IVD environment.
- Knowledge of design control systems, experience assembling documentation to support CE mark, ISO, 510(k) and/or PMA submissions.
- Proven track record of developing diagnostic tests or reagent kits.
- Scientific and business acumen leading to data-driven decisions.
- Strong ability to maintain open communication with internal employees, managers and customers as needed.
- Able to integrate and apply feedback in a professional manner.
- Able to prioritize and manage multiple concurrent projects and drive to results with a high emphasis on quality.
- Demonstrated excellent oral, written and presentation-based communication and influencing skills.
- Able to integrate and apply feedback in a professional manner
- Demonstrated ability to be highly effective in a fast-paced, rapid growth environment and strong team player.
- Strong communicator with ability to maintain open communication with internal employees, managers and customers as needed.
- Ability to work as part of a team.
- Experience with nucleic acid extraction, quantitation and qRT-PCR.
- Experience with gene expression assays using formalin fixed paraffin embedded (FFPE) tissue.
- Experience with Next Generation Sequencing technologies.
- Broad experience in cancer molecular genetics, with specific knowledge in one or more of breast cancer, prostate cancer, lung cancer and colon cancer, and immuno-oncology and successful development of products in one or more of these areas.