Head of Research & Development

Roche•Carlsbad, CA

12h•Onsite

About The Position

As a member of the GenMark Leadership Team, you will be responsible for the strategic direction and leadership of the R&D team. You will oversee the overall design, development and launch of the company’s assays, consumables and instruments. You will be responsible for the development strategy for molecular diagnostic assay products on the next generation sample to answer platform utilizing the company's ePlex® Detection technology. You will also have functional responsibility to build and develop core competency in scientific excellence in molecular diagnostics, functional consumables design, manufacturing processes, design control, clinical study and submission support. You will oversee product development for Genmark including, engineering design and scale-up processes. You will also ensure development processes comply with regulatory requirements to minimize risk to the organization, as well as address the analysis and evaluation of process development procedures and practices to ensure compliance with regulatory, legal and good manufacturing procedures to meet corporate goals. You will report to the General Manager and lead a team of Directors and Managers.

Requirements

M.S. or PhD in Life Sciences, Biochemistry, Engineering or related discipline. 10+ years’ experience with assay, consumable, and instrument platforms.
10+ years of experience in IVD, clinical diagnostics, infectious diseases, or other relevant scientific product industry.
10+ years experience managing scientific and engineering teams. Prior R&D leadership and innovation experience desired due to the technical complexity of the role. Proven track record of innovation.
A change leader must be a proactive change agent, proven ability to lead through ambiguity, possess strong conviction and foster a culture of collaboration is crucial.
Possess ability to lead effectively across a matrix organization, including demonstrated skills in getting things done and influencing, is required.
Multi-disciplinary background (education and/or experience) with domain knowledge in molecular diagnostics, molecular biology, microfluidics, systems and consumable engineering
Experience with IVD development and commercialization as well as strong skills in process development and successful transfer to operations are essential.
Familiarity with standard product development process architecture e.g., stage gates, criteria, development phases, etc.
Strong background in smart/high-tech consumable engineering, including expertise in microfluidics and PCR. Consumable engineering preferred.
Technical experience with Chemistry, Molecular Biology, Microfluidics, Electronics, In Vitro Diagnostics.
Solid analytical skills with an eye for detail to assess the impact of multiple variables on systems’ performance
Developing partnerships with RA/QA to ensure compliance with all applicable legal and regulatory standards
Ability to view technical performance and requirements in the context of customer needs
Prior experience designing & developing nucleic acid-based "sample to answer" molecular diagnostic products within a regulated environment, utilizing the design control process required highly desired.
Outstanding interpersonal skills with the ability to build teams and inspire creativity
Persuasive influencer with the ability to challenge ideas respectfully, motivate and coach teams bringing them to a higher level of performance
Strong organization skills and ability to solve ambiguous situations
Strong presentation skills
Able to identify and pursue the critical path through a complex, multi-partner environment
Comfortable with issue resolution at all level of the organization
Flexible, create and able to tolerate and bring structure to ambiguity
High level of initiative and energy, a natural self-starter
Must be proficient in writing, and communicating in the English language.
Must be consistent with a Ph.D. level education
Good problem solving, judgment and decision-making skills are required.
Strong networking capabilities to sustainably foster the team’s collaboration with the wider R&D organization and other divisional functions.

Responsibilities

Directs and manages multiple programs to develop assays and systems for future ePlex® products.
Oversees system-level design and technical review
Guide the creation and execution of an integrated program plan to develop and launch new products
Guide the creation and execution of an integrated program plan for any product development activities needed for on market product/ PCQT (Product Care Quality Team deliverables.
Drives cross-functional teams to deliver new products to specifications, on time and on budget.
Leads a team of Directors and Managers in technology assessments and development for automation of DNA/RNA extraction, PCR and assay integration of assays onto sample to answer platforms.
Works closely with the Clinical, Regulatory and Quality departments for successful clinical studies, regulatory submissions and design control processes.
Collaborate with manufacturing and supply chain to facilitate effective transfer of assays to manufacturing.
Engage, influence, and direct all functions and partners involved in product development
Aligns with Marketing and Sales on new product requirements and commercialization activities.
Accountable for ensuring products meet customer needs and business objectives
Guide the team to generate novel ideas for defining, developing and launching new products
Manage project and product risks and initiate reviews with oversight committee if necessary
Manage project and department budgets and actively make tradeoff calls between schedule, scope and resources to meet overall program and business objectives
Reinforce business perspective and enterprise thinking during development process
Act as product champion internally and externally
Maintains organizational focus and expertise on innovation best practices and scientific excellence.
Hands-on leader that can inspirationally motivate a team to meet challenging but achievable program deliverables.
Provides an open environment and promotes teamwork across the organization.
Fosters know-how exchange and collaboration with global R&D teams within the Roche Diagnostics Division. Leverages their expertise in projects to achieve Genmark’s business goals.
Builds and provides leadership for an effective team including hiring, on-boarding, developing, goal setting, performance improvement and disciplinary actions.
Effectively utilizes internal and external resources to meet project objectives.
Demonstrates and advocates Our Operating Principles.
Oversees Bio-Engineering, Product Engineering, Instrument Engineering and Services, Product Technical Support
Will lead a team of 140 employees with 7+ direct reports into this leader. He/She will coordinate efforts of the department with those of senior technical staff and management from other departments.