What are the responsibilities and job description for the Clinical Pharmacology Systems Specialist position at Excelra?
Location: Princeton New Jersey USA (Hybrid, in office when needed)
Working hours: US Eastern Time (EST)
Experience: 8 years
Department : Clinical Pharmacology, working closely with IT, QA, InfoSec, Data Security and AI teams
About The Role
We need an experienced Clinical Pharmacology Systems Specialist to connect our Clinical Pharmacology (ClinPharm) team with IT. You'll handle the technical side of ClinPharm tools and platforms: setting them up, deploying them and keeping them running. You'll also make sure every system follows GxP rules and is fully validated and documented. You'll also help us bring AI and LLM (large language model) tools into ClinPharm work in a safe and compliant way.
Key Responsibilities
IT Liaison and Communication
GxP Validation
Working hours: US Eastern Time (EST)
Experience: 8 years
Department : Clinical Pharmacology, working closely with IT, QA, InfoSec, Data Security and AI teams
About The Role
We need an experienced Clinical Pharmacology Systems Specialist to connect our Clinical Pharmacology (ClinPharm) team with IT. You'll handle the technical side of ClinPharm tools and platforms: setting them up, deploying them and keeping them running. You'll also make sure every system follows GxP rules and is fully validated and documented. You'll also help us bring AI and LLM (large language model) tools into ClinPharm work in a safe and compliant way.
Key Responsibilities
IT Liaison and Communication
- Be the main link between the Clinical Pharmacology team and IT for anything technical.
- Lead communication with IT whenever ClinPharm tools are set up, upgraded, or maintained.
- Turn ClinPharm business needs into clear technical requirements and explain technical limits back to scientists in simple terms.
- Track open requests, issues, and timelines, and keep everyone informed.
- Help deploy, implement, and maintain ClinPharm platforms and tools (for example PK/PD modeling software, NCA tools, data platforms and scientific computing environments).
- Take part in the full system lifecycle: requirements, vendor review, installation, setup, testing, go-live and support.
- Plan and support upgrades, patches, change requests and system retirement.
- Make sure systems stay available and reliable, and handle incidents with IT.
- Plan and run GxP testing, including IQ, OQ and PQ, user acceptance testing (UAT) and regression testing.
- Write and maintain validation documents, such as validation plans, user and functional requirements, risk assessments, test scripts, traceability matrices, summary reports and SOPs.
- Build and improve GxP processes around each tool, covering change control, access management, audit trails, backup and restore, and periodic review.
- Follow 21 CFR Part 11, EU Annex 11, GAMP 5 and data integrity (ALCOA ) principles.
- Support internal audits and regulatory inspections that involve ClinPharm systems.
- Keep up with AI and LLM tools that could help clinical pharmacology work.
- Help evaluate, deploy and implement AI/LLM solutions with the AI, IT and InfoSec teams.
- Help set up validation, governance and risk controls for AI tools used in a GxP setting.
- Work closely with IT, QA, InfoSec, Data Security and AI teams.
- Make sure new tools pass security reviews, data privacy checks and QA approval before go-live.
- Coordinate with outside vendors on implementation, support and validation packages.
- Bachelor's or Master's degree in Life Sciences, Pharmacy, Computer Science, Information Systems or a related field.
- 8 years of experience in pharma, biotech, or a CRO, in a role covering IT systems, computer system validation (CSV/CSA) or scientific platform support.
- Hands-on experience with GxP testing and validation documentation.
- Proven experience deploying and maintaining enterprise or scientific software.
- Good knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5 and data integrity rules.
- Working knowledge of AI and LLM tools, including how they are deployed and the risks and controls they need.
- Strong communication skills, with the ability to explain technical topics to non-technical people and the other way round.
- Available during US EST hours and able to come into the office when needed.
- A background in clinical pharmacology, or knowledge or experience of it (PK/PD, NCA, population PK, exposure-response).
- Familiarity with ClinPharm tools such as Phoenix WinNonlin/NLME, NONMEM, R/RStudio, Monolix, Simcyp or similar.
- Experience with cloud platforms (AWS), Linux servers, or high-performance computing environments.
- Exposure to CSA (Computer Software Assurance) approaches.
- Worked with Systems like Metworx, MATLAB and PK-Sim
GxP Validation
- CSV/CSA
- IQ/OQ/PQ
- UAT
- SOP Writing
- Change Control
- IT Liaison
- System Deployment
- AI/LLM Awareness
- Cross-Team Communication
- Vendor Management
- Clinical Pharmacology (preferred)