Director (Senior Director) Product Development

LOCATION: USA East Coast
JOB TYPE: Remote

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 one or many CONFORM™ products. 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 acting as a Product Owner and he/she 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, decentralized trials, 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 commercial growth, usability, performance and level of services.preferred

Responsibilities:

  • Develop or enhance products in one or more than one clinical application areas
  • 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
  • Participate in RFP/RFI writing and bid defenses as a product expert
  • Prepare materials and participate in industry forums and conferences
  • Participate or assist in solution implementation, if required
  • Participate in corporate audits, if required

Skills needed:

  • Visionary business application mindset with great attention to detail
  • Demonstrated high quality organizational and leadership skills
  • 10+ years of hands-on experience in pharmaceutical clinical business and clinical information technology
  • 5+ years in Life Sciences project and/or product management role
  • Expert knowledge of CR&D business processes
  • Demonstrated experience in multiple clinical processes and applications (i.e. data collection, trial conduct, management and operations, clinical data review, data standardization, data transformation, data warehousing, operational analytics)
  • Practical experience with at least one Clinical SaaS platform
  • Excellent knowledge of clinical systems and vendors commonly used in the industry
  • Understanding of quality and information privacy requirements applicable to clinical systems
  • Practical experience in design, development and management of large clinical systems and databases
  • 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

Work Requirements:

  • Being able to work remotely and to travel to the corporate office (Princeton, NJ) when required
  • Availability in early and late hours to participate in scheduled global online meetings over the Internet
  • Cross-functional and client interactions
  • USA Residents or Citizens only

Education:

  • BS/BA in computer science, engineering, mathematics, business, life sciences or relevant field, MS/MBA preferred

Send your resume to hr@edetek.com.