EDETEK provides comprehensive business and technical solutions to advance the science of medicine and improve the quality of life of people around the world. We utilize our clinical platform CONFORM™, to fulfill our customers’ data engineering and business analytics needs. Our comprehensive metadata driven solutions, coupled with our extensive experience, knowledge and capabilities allow us to offer unparalleled advantages in data quality, time to completion, and cost efficiency EDETEK is a culturally diverse company that is revolutionizing the way Life Sciences uses data.
Position Summary: Director (Senior Director) Product Development, Clinical Information Repository
Location: Remote, USA East Coast
We are looking for highly motivated and experienced clinical business technology visionaries that have a passion for development of innovative industry leading processes and systems to improve and further differentiate our products.
Director of Product Development will be responsible for product development management, conceptual design as well as business, regulatory and technical requirements definitions of EDETEK products. Director of Product Development will be coordinating development of one or more than one product of the CONFORM platforms. Project management and coordination activities will include interactions with the senior leadership team, architecture, software engineering, business analysis and quality departments of the product development division
Director of Product Development is solely responsible for meeting all product development objectives, timelines, budget and quality while managing all product contributors on a matrix basis.
This position may have direct reports – Product Specialists, depending on product’s scope and complexity.
Product Development Director must be able to function effectively and on a daily basis in a mixed environment of activities that range from low level development hands off tasks to high-level visionary discussions as well as senior level presentations internally and externally.
An ideal candidate must possess strong knowledge of clinical patient and operational information flows. He/She must be skilled in industry-popular systems used in clinical trials. An ideal candidate should have a vision for improvements of existing and innovative capabilities of future clinical applications such as management of structured and unstructured data, adaptive trials, near real time data processing, machine learning, etc.
Director of Product Development will become the ultimate expert in EDETEK products he/she is assigned to. This position will drive and balance product innovation, practical design specifications with development timelines and budget. He/She will provide business and technological ideas based on market needs, make recommendations for product’s road map to improve usability, performance and level of services.
- Develop or enhance products in one or more than one clinical application areas
- This position focuses on CONFORM’s business and technical components that support storage and management of structured and unstructured clinical information in the clinical data lake and databases
- Collaborate with business analysts, architects, internal subject matter experts, product engineering to develop functional requirements for new applications
- Work with Product QA to ensure GxP and 21 CFR Part 11 compliance of the systems
- Clearly translate business requirements to the business analysts working on the project
- Assess complexity, cost and timing of new solutions from business and technology perspectives
- Manage project timelines approved by management
- Manage people and teams on a matrix basis and directly as required
- Guide business analysts to develop and document process and information flows
- Develop specifications for information integration within EDETEK CONFORM™ applications, and up and down stream external systems
- Participate in RFP/RFI writing and bid defenses as a product expert
- Prepare materials and participate in industry forums and conferences
- Participate in solution implementation, if required
- Participate in corporate audits, if required
- 10+ years of hands-on experience in pharmaceutical clinical business and clinical information technology
- Expert knowledge of CR&D processes
- 5+ years in Life Sciences project and/or product management role
- Demonstrated experience as a leader in multiple clinical processes and applications (i.e. data collection, trial conduct, management and operations, data standardization, data transformation, data warehousing, analytics)
- Practical experience with Clinical SaaS platforms
- Excellent knowledge of clinical systems and vendors commonly used in the industry
- Understanding of quality and information privacy requirements applicable to clinical systems
- Understanding of the cloud-based data lake concept, practical experience is a plus
- Practical experience in design and management of large clinical data bases and/or data warehouses
- Outstanding communication and presentation abilities, including presentations to customers and industry
- Ability to work with EDETEK teams in various globally distributed regions
- Business experience with Clinical Data Standards (CDISC, HL7, etc.)
- Familiarity with Cloud Computing, practical experience is a plus
- Understanding of metadata and event driven processes and technologies
- Knowledge of GxP, 21 CFR Part 11 and HIPAA requirements
- Understanding of product development and SDLC
- Visionary business application mindset with great attention to detail
- Demonstrated high quality organizational and leadership skills
- Being able to work in the corporate office (Princeton, NJ) and home office remotely
- The ideal candidate must reside within one-hour commute distance from Princeton, NJ. Remote locations may be considered
- Availability in early and late hours to participate in scheduled global online meetings over the Internet/Skype
- Cross-functional and client interactions
- USA Residents or Citizens only
- BS/BA in computer science, engineering, mathematics, business, life sciences or relevant field, MS/MBA preferred