Senior Consultant

Excelra Knowledge Solutions Pvt. Ltd.; Cambridge (MA); Hybride; USD 140 000 - 210 000; Plein temps

Résumé du poste

Darwinbox Digital Solutions Pvt. Ltd. in Cambridge, MA seeks an experienced Clinical Pharmacology Systems Specialist to bridge ClinPharm and IT. You will deploy, validate and maintain pharmacology tools, ensure GxP compliance, and guide AI/LLM integration within a regulated environment.

Qualifications include 8+ years in pharma/biotech IT, CS/IS background, and deep knowledge of CSV/CSA and regulatory standards. The role is hybrid, with in-office collaboration as needed and EST hours.

Qualifications

• Bachelor's or Master's in Life Sciences, Pharmacy, Computer Science, Information Systems or a related field.
• 8+ years in pharma/biotech/CRO IT systems, CSV/CSA or scientific platform support.
• Hands-on GxP testing and validation documentation experience.
• Proven experience deploying and maintaining enterprise or scientific software.
• Knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5 and data integrity rules.
• Familiarity with AI/LLM tools and deployment considerations.

Responsabilités

• Serve as IT liaison between ClinPharm and IT for technical needs.
• Lead deployment, upgrades and maintenance of ClinPharm platforms and tools.
• Ensure systems are validated, documented and compliant (IQ/OQ/PQ, UAT, risk assessments).
• Implement data integrity, access controls, audit trails and change control processes.
• Coordinate with vendors for validation, support and lifecycle management.
• Work with AI/LLM initiatives ensuring safety, governance and QA approvals.

Connaissances

GxP compliance

IT liaison

Communication

Problem solving

Formation

Bachelor's or Master's in Life Sciences/Pharmacy/CS/IS

Outils

PK/PD software

NCA tools

GxP validation docs

Description du poste

Cambridge, Cambridge, Massachusetts, United States

Consultant

Job Description

Job Description: Clinical Pharmacology Systems Specialist

Location: 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

• 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.

Tool and Platform Implementation

• 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.

GxP Compliance, Testing and Documentation

• 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.

AI and LLM Tools

• 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.

Required Qualifications

• 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.

Nice to Have

• 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.
• Project management or ITIL certification.

Key Skills

Job Snapshot

Updated Date

01-10-2026

Job ID

JOB880

Department

Scientific Informatics

Location

Location Cambridge, Cambridge, Massachusetts, United States