Director of Computational Biology and Software (Microarray)

BACKGROUND

Our client, located in Toronto - the fifth largest city in North America, is developing a line of gene expression diagnostic products with superior clinical utility using its proprietary technology. The success of our client depends on the talents, efforts and achievements of their employees. The incumbent will be responsibility for directing a multidisciplinary group of individuals in software development and bioinformatics. The incumbent will drive the design, development and validation processes for novel software analysis applications which will form an integral part of their technology of molecular diagnostic products. The incumbent will also manage the informatic infrastructure and activities to ensure Company strategic goals are achieved. Strong managerial and organizational skills will be required for team building and project management.

RESPONSIBILITIES:
Overseeing the implementation of the Company’s infrastructure to develop software applications in alignment with the Company’s Quality Management System, international regulatory guidelines (QSR and ISO13485) and using software development best practices;
Leading a team in development of software applications for the Company’s In vitro diagnostic products;

Directing the development of informatics systems – tools, databases, analytical methods as appropriate to achieve the Company’s strategic goals;
Managing the integration of activities among the bench scientists, bioinformaticians and software personnel;

Providing leadership to IT, Informatics, Software and Quality groups to build, implement and maintain a computer validation master plan and supporting program elements that ensures full compliance with all regulatory agencies during the development, modification and implementation of GxP related computer systems across all functions and departments;

Managing the day-to-day activities of junior members within group by providing leadership, knowledge transfer and related guidance, evaluations of performance, and the management of directives and priorities;

Overseeing resource planning, scheduling, quality, cost and compliance of group;

Developing departmental goals, objectives and metrics supportive of the Company’s strategy goal and quality policies;

Maintaining awareness of relevant areas of research and competitive activity through reading the literature and occasional attendance of appropriate scientific meetings; and

Providing software development input to regulatory submissions and represent the Company during regulatory and client audits.

REQUIREMENTS

A PhD in biology, mathematics, bioinformatics, computer science, or equivalent with 5+ years of relevant and increasingly responsible industry experience.
Thorough knowledge of GxPs, FDA & EMEA Regulations governing validation including 21CFR Part 11.
Strong computational, mathematical, logical and statistical skills.
Experience designing and implementing validation programs, writing and implementing SOP's, templates and other quality system infrastructure.
Excellent organizational, technical planning, supervisory, managerial and time management skills.
Excellent communication skills, verbal and written.
Ability to manage via influence rather than control and work across departmental boundaries.

HOW TO APPLY

Michael Kalchman, PhD (Genetics)
michael[at]cortexhr.com