Associate Director, R&D IT
Perspective Therapeutics, Inc., Coralville, Iowa, United States, 52241
Associate Director, R&D IT
The objective of the
Associate Director, R&D IT
role is to provide strategic, hands‑on technology leadership across the full R&D lifecycle—enabling Clinical Development, Clinical Operations, Preclinical/Discovery, Regulatory Affairs, Quality (QA/QC), CMC, Operations, and Supply Chain with modern, scalable, compliant digital solutions. The role also ensures Phase 3 readiness, including the digital, data, and system capabilities needed for late‑stage clinical execution and regulatory scrutiny. Essential Functions
Strategic Leadership & Alignment:
Provide strategic IT leadership across R&D, Clinical, Regulatory, Quality, CMC, Operations, and Supply Chain, ensuring technology initiatives align with scientific, operational, and compliance priorities. Define and drive technology roadmaps that support Phase 3 readiness, operational scale‑up, and long‑term digital maturity. Systems Ownership, Lifecycle Management & Validation:
Oversee implementation, optimization, and lifecycle management of scientific, clinical, regulatory, quality, and manufacturing systems. Lead system validation activities, including authoring and reviewing Computer System Validation (CSV) deliverables in alignment with GxP, 21 CFR Part 11, data integrity, and internal SOPs and IT Policies. Maintain accountability for system administration, configuration management, change control, and ongoing maintenance across R&D, Clinical, Quality, and Operations applications. Operational Excellence & IT Service Delivery:
Ensure reliable day‑to‑day IT Lab operations in partnership with managed service providers, maintaining system uptime, cybersecurity standards, and white‑glove end‑user support. Drive governance of IT procedures, SOPs, validation documentation, and operational controls to uphold regulatory and site‑readiness requirements. Facility Expansion, Manufacturing Enablement & Infrastructure Readiness:
Support new facility buildouts by enabling digital infrastructure planning, system selection, commissioning, qualification, validation, and readiness for clinical and commercial manufacturing. Lead cross‑functional initiatives supporting clinical trial execution, regulatory submissions, inspection readiness, and manufacturing scale‑up. Education/Experience Bachelor’s degree in Information Technology, Computer Science, Engineering, or a related field; advanced degree preferred. 7+ years supporting Clinical, Regulatory, Quality, CMC, Operations, or R&D IT systems in biotech/pharma. Experience with validated systems, Change Control, Computer System Validation, and regulated system governance. Hands‑on experience with scientific, clinical, quality, regulatory, or manufacturing applications. Demonstrated experience leading cross‑functional initiatives and partnering with scientific, clinical, regulatory, and operations leaders. Experience leading or mentoring technical staff, vendors, or cross‑functional project teams. Experience managing IT vendors, contracts, and budgeted initiatives. Preferred Qualifications
Experience providing remote IT support across distributed teams. Experience supporting radiopharmaceutical or highly regulated manufacturing environments. Familiarity with isotope development, analytical chemistry, and QC/QA laboratory workflows. Experience supporting manufacturing site buildouts, commissioning, qualification, and validation. Understanding of regulatory frameworks such as GxP, 21 CFR Part 11, data integrity, FDA, and nuclear regulatory requirements. Familiarity with LIMS, ELN, CTMS, eTMF, QMS, RIMS, and other scientific/clinical systems. Experience working with outsourced IT providers or hybrid internal/external support models. Understanding of compliance and cybersecurity frameworks relevant to regulated environments (e.g., GxP, SOX, HIPAA, GDPR). Knowledge / Skill / Abilities
Excellent written, verbal, and presentation skills; able to communicate effectively across scientific, regulatory, quality, and operational functions. Strong analytical and problem‑solving abilities, including root‑cause analysis in regulated environments. Ability to manage competing priorities, operate both strategically and tactically, and work independently or collaboratively. Strong organizational skills with attention to detail and documentation rigor. Proven ability to build effective cross‑functional relationships and operate as a trusted advisor. Work Environment
This role is based out of Perspective’s Coralville, Iowa offices and labs. Travel up to 30% may be required. Must be willing to work in a facility producing radioactive materials and to participate in safety programs designed to minimize exposure levels. Mechanical aptitude required; manual dexterity for manipulating small items; ability to lift up to 50 lbs. and to handle frequent crawling, stooping, crouching, and kneeling. Must be willing to wear a variety of personal protective equipment and complete safety training within allotted timeframes. Willingness to work in a team‑based environment. Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
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The objective of the
Associate Director, R&D IT
role is to provide strategic, hands‑on technology leadership across the full R&D lifecycle—enabling Clinical Development, Clinical Operations, Preclinical/Discovery, Regulatory Affairs, Quality (QA/QC), CMC, Operations, and Supply Chain with modern, scalable, compliant digital solutions. The role also ensures Phase 3 readiness, including the digital, data, and system capabilities needed for late‑stage clinical execution and regulatory scrutiny. Essential Functions
Strategic Leadership & Alignment:
Provide strategic IT leadership across R&D, Clinical, Regulatory, Quality, CMC, Operations, and Supply Chain, ensuring technology initiatives align with scientific, operational, and compliance priorities. Define and drive technology roadmaps that support Phase 3 readiness, operational scale‑up, and long‑term digital maturity. Systems Ownership, Lifecycle Management & Validation:
Oversee implementation, optimization, and lifecycle management of scientific, clinical, regulatory, quality, and manufacturing systems. Lead system validation activities, including authoring and reviewing Computer System Validation (CSV) deliverables in alignment with GxP, 21 CFR Part 11, data integrity, and internal SOPs and IT Policies. Maintain accountability for system administration, configuration management, change control, and ongoing maintenance across R&D, Clinical, Quality, and Operations applications. Operational Excellence & IT Service Delivery:
Ensure reliable day‑to‑day IT Lab operations in partnership with managed service providers, maintaining system uptime, cybersecurity standards, and white‑glove end‑user support. Drive governance of IT procedures, SOPs, validation documentation, and operational controls to uphold regulatory and site‑readiness requirements. Facility Expansion, Manufacturing Enablement & Infrastructure Readiness:
Support new facility buildouts by enabling digital infrastructure planning, system selection, commissioning, qualification, validation, and readiness for clinical and commercial manufacturing. Lead cross‑functional initiatives supporting clinical trial execution, regulatory submissions, inspection readiness, and manufacturing scale‑up. Education/Experience Bachelor’s degree in Information Technology, Computer Science, Engineering, or a related field; advanced degree preferred. 7+ years supporting Clinical, Regulatory, Quality, CMC, Operations, or R&D IT systems in biotech/pharma. Experience with validated systems, Change Control, Computer System Validation, and regulated system governance. Hands‑on experience with scientific, clinical, quality, regulatory, or manufacturing applications. Demonstrated experience leading cross‑functional initiatives and partnering with scientific, clinical, regulatory, and operations leaders. Experience leading or mentoring technical staff, vendors, or cross‑functional project teams. Experience managing IT vendors, contracts, and budgeted initiatives. Preferred Qualifications
Experience providing remote IT support across distributed teams. Experience supporting radiopharmaceutical or highly regulated manufacturing environments. Familiarity with isotope development, analytical chemistry, and QC/QA laboratory workflows. Experience supporting manufacturing site buildouts, commissioning, qualification, and validation. Understanding of regulatory frameworks such as GxP, 21 CFR Part 11, data integrity, FDA, and nuclear regulatory requirements. Familiarity with LIMS, ELN, CTMS, eTMF, QMS, RIMS, and other scientific/clinical systems. Experience working with outsourced IT providers or hybrid internal/external support models. Understanding of compliance and cybersecurity frameworks relevant to regulated environments (e.g., GxP, SOX, HIPAA, GDPR). Knowledge / Skill / Abilities
Excellent written, verbal, and presentation skills; able to communicate effectively across scientific, regulatory, quality, and operational functions. Strong analytical and problem‑solving abilities, including root‑cause analysis in regulated environments. Ability to manage competing priorities, operate both strategically and tactically, and work independently or collaboratively. Strong organizational skills with attention to detail and documentation rigor. Proven ability to build effective cross‑functional relationships and operate as a trusted advisor. Work Environment
This role is based out of Perspective’s Coralville, Iowa offices and labs. Travel up to 30% may be required. Must be willing to work in a facility producing radioactive materials and to participate in safety programs designed to minimize exposure levels. Mechanical aptitude required; manual dexterity for manipulating small items; ability to lift up to 50 lbs. and to handle frequent crawling, stooping, crouching, and kneeling. Must be willing to wear a variety of personal protective equipment and complete safety training within allotted timeframes. Willingness to work in a team‑based environment. Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
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