VP, Product & Process Development

Job Description

Job Description

The VP, Product & Process Development ("VP, Development") is a key R&D leader who oversees and manages the execution of initiatives, projects, and procedures to support the ongoing advancement of CND's neurodiagnostics product development pipeline, continuous process improvements for its CLIA laboratories, and digital innovation solutions that support the company's pathology capabilities. The VP, Development is an experienced R&D department leader with more than a decade of forming, mentoring, and driving the performance of product development and engineering teams in medical device, diagnostics, or related companies. He/she is effective in developing and managing department budgets, reporting progress to executive leaders, and meeting project milestones and timelines. The VP, Development has a history of success leading structured product development and validation processes in collaboration with R&D, RAQA, Medical Affairs and Commercial stakeholders including playing a central role with successful FDA 510K and/or de novo device submissions. He/she is a strong engineering leader with proven experience assessing and improving core manufacturing and/or laboratory processes to achieve quality and cost-effectiveness goals of the company. He/she has collaborated regularly with commercial production and and/or laboratory leadership to help identify near and long-term improvement opportunities and has led key projects resulting in measurable efficiency and productivity outcomes. The VP, Development is also familiar with leveraging digital technologies to create new product and process capabilities for the company and applying expert resources and partners in seamless ways.

A scientist by background, the VP, Development has demonstrated strong career trajectory in life sciences companies to take on broad-based team management responsibilities. He/she has a deep appreciation of and commitment to scientific collaboration, is open to ideas, and getting the best out of all teammates. He/she will interact regularly with other functional leaders at the company to contribute to the overall strategy and mission and be a close partner to the Chief Scientific Officer in the execution of plans established on an annual basis. Success in this role will stem from a strong knowledge of the engineering, scientific, and regulatory environments related to in vitro diagnostics and the ability to analyze data to manage product development, technical validation, and innovation. Additionally, experience driving high complexity projects through completion is critical. The VP, Development has excellent organizations skills, the ability to adapt quickly, and eagerness to use a hands-on approach to support troubleshooting and problem solving.

The VP, Development brings a wealth of scientific and engineering skill sets and relevant experiences to the company. He/she is knowledgeable of the field of neurodiagnostics and the use of immunohistochemistry and immunofluorescence techniques as the basis of the company's current product portfolio. He/she is committed strongly to the field of neurodegeneration and believes passionately in CND's mission leveraging skin as a window into the central nervous system while sharing a desire to extend the mission to biofluids and emerging technologies.

Job Responsibilities:

Core Responsibilities

• At the direction of the CSO and aligned with Board-approved company plans, oversee, manage, and guide the activities of four core R&D areas of the company: (i) product development (assays); (ii) process engineering and continuous improvement; (iii) digital innovation, and (iv) R&D lab tissue processing for external research clients
• Oversee the execution of a significant portion of the R&D budget including managing any variances and coordinating with Finance
• Maintain all project plans and initiatives, keeping teams on tasks, timelines and deliverables while communicating progress and constraints to company leadership
• Support the project prioritization process and provide key recommendations for go/no-go decisions
• Drive all approved hiring, onboarding, and mentoring of staff
• Working alongside Regulatory Affairs to draft FDA and CE-mark applications for the company's products; gain inputs from and regularly communicate with scientific and medical leadership on these projects
• In collaboration with other scientific leaders, play a key role in assisting the active management of the IP portfolio and work closely with outside counsel to maintain IP filings, prosecutions, etc.; document and codify all trade secrets and manage accordingly
• Oversee the conduct of validation studies, including working with company leadership on study designs, plans, and outcomes while collaborating with RAQA functions
• Ensure the R&D lab's compliance with all agency requirements
• Manage certain R&D alliances with outside research groups and ensure the performance of projects and programs meet endpoints
• Provide critical ideas for ongoing product and process innovation
• Participate in key R&D projects providing hands-on research design and engineering expertise to fulfill objectives
• Oversight and hands-on leadership of the following functional areas within the R&D organization:

Product development and validation

• In collaboration with R&D, Regulatory, and Commercial leaders, establish clear assay development and validation plans and processes for current and future neurodiagnostics products
• Oversee a team of product development engineers and technicians to achieve goals; establish clear project plans with timelines, resources, milestones and budgets
• Ensure alignment with all regulatory requirements and coordinate effectively with leaders on both ends of the product development life cycle (i.e., Discovery and Commercial) to deliver on product specifications

Process engineering and continuous improvement

• In collaboration with R&D, Regulatory, and Operations leaders, establish clear laboratory process improvement objectives, validation plans, and implementation roadmaps for initiatives that increase quality, reduce costs, or create new product capabilities.
• Oversee a team of process development engineers and technicians to achieve goals; establish clear project plans with timelines, resources, milestones and budgets
• Ensure alignment with all regulatory requirements and coordinate effectively with leaders on both ends of the process development life cycle (i.e., Discovery and Operations) to deliver on process specifications
• Work with RAQA to draft and implement new SOPs and training documents

Digital innovation

• Oversee a team of digital engineers working on the company's digital pathology technologies including the AI-assisted NerValence system
• Establish development goals and clear project plans with timelines, resources, milestones and budgets
• Form close and effective collaboration relationships with digital pathology partners including Evident and Visiopharm; play a leadership role to optimize these relationships
• Guide the team to explore potential new technologies that can improve the pathology capabilities and scalability

R&D lab tissue processing for external research clients

• Along with the VP, Scientific Discovery and/or the R&D Lab Medical Director, oversee the day-to-day work and deliverables of the R&D Lab's tissue processing function for external research clients
• Delegate to the Lab Manager the responsibility of ensuring the lab has up-to-date SOPs, adequate staffing plans, equipment, supplies, and meets all CLIA regulatory requirements
• Serve as a mentor when needed

Knowledge, Skills & Experience:

• 15+ years of experience in product development and engineering in medical devices, diagnostics, or other life sciences sector with at least five (5) years in a successful leadership role
• Experience with assay development and validation and clear familiarity with immunohistochemistry and immunofluorescence a plus
• Experience with various regulatory processes and standards including CLIA, CAP, ISO, and others
• Proven analytical skills and knowledge of system trouble-shooting methodologies
• Successful product and process development achievements in high-growth life science company environment
• Clear competency in portfolio project management, work prioritization, and resource management
• History of effectiveness management and mentoring of team members to optimize their performance and career trajectories

Education, Certifications & Licensures:

• Master's degree or Ph.D. in engineering, biosciences, or related field is required.
• Executive education or program certifications in digital/AI technologies a plus.

Other:

• This position is based in our Scottsdale, AZ headquarters where the CLIA-certified R&D laboratory is located
• Quarterly travel to CND's Boston-area office to meet with CSO/scientific staff