Associate/Director, Clinical Operations

Organization
NanoString Technologies
Job Location
530 Fairview Ave
Seattle, WA 98109
Benefits

Medical, dental, 401k, stock options, ESPP

Job Description

The Director, Clinical Operations position, will report to the Chief Medical officer and will provide overall leadership for NanoString Clinical Operations group including hiring, mentoring, professional development and performance management of the staff, as well as oversight for execution of clinical programs including timelines, budgets, resources, clinical trial sites, vendors and key project deliverables. The position includes responsibility for continuous improvement of scalable and rigorous department infrastructure and processes through the development of SOPs, guidelines and the use of technology, which will be critical to the success of NanoString Clinical Programs, including multiple CDx activities.

Essential Functions:

  • Provide clinical operations leadership and perspective in defining NanoString Clinical Operations group and overseeing its processes and execution of clinical study programs, including multiple CDx activities.
  • Hire, supervise and train operations personnel as appropriate and assume ownership of the quality of clinical programs and deliverables.
  • Set annual goals, objectives and development plans for staff, provide performance feedback and conduct performance evaluations
  • Ensure operational feasibility of clinical development plans and scenarios, including timeline, budget and resource requirements. Ensure all study activities are completed in accordance with ICH GCP, health authority regulations and SOPs.
  • Lead strategic discussions regarding program and study resourcing, including outsourcing requirements at the study, program, and corporate levels.
  • Guide study team in vendor selection and provide management oversight throughout the life of all assigned clinical projects. Proposes vendors for approval.
  • Determine operational feasibility and implementation path of the study/program objectives; manages and communicates to senior management and key stakeholders.
  • Work with other project team leaders to review the study documents including clinical trial protocol, amendment, informed consent form, case report forms, investigator brochure, site and third party vendor contracts, clinical study reports, etc.
  • Partner with other project team members in managing relationship with corporate partners on studies/programs, as applicable, for clinical operations.
  • Identify and provide solutions and direction related to key cross-­functional, sponsor-­site, and sponsor­-CRO clinical trial issues.
  • Develop, implement and maintain standards across clinical programs to ensure scalability and rigor of NanoString  Clinical Operations.
Requirements

10+ years of progressive experience in clinical research and/or clinical trial operations, and a minimum of 3 years in a supervisory role managing clinical operations staff.

  • BA/BS in life sciences or healthcare field required; advanced degrees (e.g. Ph.D.) a plus.
  • Industry experience within medical device fields, with in vitro diagnostics (IVD) and genomic medicine highly preferred.
  • Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements.
  • Strong track record of effective performance in cross-­functional environment, including successful relationships with data management, bioinformatics, biostatistics, medical writing, and regulatory affairs.
  • People management and team leadership skills to motivate staff and drive quality processes.
  • Excellent verbal and written communication and presentation skills, interpersonal and negotiation skills, organizational and problem solving skills.
  • Demonstrated, effective planning and project management skills, including risk assessment, contingency planning and ability to prioritize effectively.
  • Ability to travel as required (up to 25%). 
About Our Organization

NanoString Technologies is a publicly held provider of life science tools for translational research and molecular diagnostics. The company's technology enables a wide variety of basic research, translational medicine and in vitro diagnostics applications.

NanoString's products are based on a novel digital molecular barcoding technology invented at the Institute for Systems Biology (ISB) in Seattle under direction of Dr. Leroy Hood. The company was founded in 2003 with an exclusive license to develop and market the technology. In 2008, NanoString launched its first commercial instrument system and began international sales operations with its first multiplexed assays for gene expression analysis. In 2010, the company launched new applications for the system to support microRNA analysis and copy number variation detection, and in 2013 launched Prosigna, its first in vitro diagnostic product for prognosis of early stage breast cancer.

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