Principal Engineer, Investigator – Patient Solutions

Role Overview

• Lead the identification and implementation of technology solutions designed to optimize processes and deliver measurable value.
• Lead continuous improvement initiatives, identifying new tools, processes, or technologies that enhance study team, patient and site engagement strategies.
• Troubleshoot system-wide issues, serving as a point of escalation for technical challenges that impact I&PS activities.
• Ensure robust project management practices, including developing business cases, project plans, and financial oversight, are applied to solution delivery.
• Partner with IT and vendors to ensure strong system change control strategies, minimizing disruption and aligning updates with best practices.
• Manage financial planning and budgets, ensuring efficient allocation of resources for technology implementation and continuous improvement.
• Lead a high-functioning and diverse team to enable industry-leading inspection-ready practices for the supported capabilities, with a focus on delivering measurable value for stakeholders.
• Lead change management efforts, promoting the adoption of new tools and ensuring clinical trial teams are well-equipped to use them effectively.
• Remaining connected as a primary point of contact with stakeholders, functional area points of contact and subject matter expert frameworks.
• Provide ongoing training and support, ensuring clinical study teams have the resources they need to maximize tools and processes.
• Engage in System/Process audits and Sponsor Inspections as a subject matter expert for supported capabilities.
• Lead and/or contribute to cross-functional strategic projects.
• Train and mentor colleagues.
• Serve as Owner for I&PS capabilities.
• Represent on/lead organizational initiatives.

Requirements

• A minimum of a bachelor’s degree or equivalent is required, preferably in Health, Science, Information Technology or another relevant field.
• A minimum of 6 years of relevant industry experience with a Pharmaceutical, Medical Device company and/or a Clinical Research Organization (CRO) is required.
• Proficiency supporting IT systems and related processes that support clinical development, reporting tools, Office 365 applications, and database administration is required.
• Solid understanding of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations, is required.
• The ability to partner and influence people at all levels of the organization is required.
• Superior communication, business partnering, problem solving, and prioritization skills are required.
• Project Management or Process Improvement certification is preferred.
• Ability to travel up to 10% of the time (Domestic/International) is required.
• Ability to communicate effectively in English.
• Global business mindset.

Benefits

• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year; Sick time
• 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year; Holiday pay, including Floating Holidays –13 days per calendar year; Work, Personal and Family Time
• up to 40 hours per calendar year; Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child; Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year; Caregiver Leave – 80 hours in a 52-week rolling period10 days; Volunteer Leave – 32 hours per calendar year; Military Spouse Time-Off – 80 hours per calendar year.