Clinical Pharmacologist

Role Summary

The Clinical Pharmacologist (CPst) plays a key role in the design, execution, analysis, interpretation, and reporting of clinical pharmacology trials throughout the drug development lifecycle. Operating within a cross-functional matrix environment, this role provides medical and scientific expertise to study teams, supports regulatory submissions, and contributes to PK/PD data interpretation. The candidate will work closely with key internal and external stakeholders under line management supervision where appropriate.

Key Responsibilities & Functions

Core Responsibilities

• Study Leadership & Execution: Lead Phase I and Phase IIa clinical pharmacology trials, including writing, reviewing, and delivering protocols, study reports, statistical analysis plans, and trial summaries on time, within budget, and to high quality standards.
• Clinical & Regulatory Strategy:
• Develop Clinical Pharmacology (CP) trial plans and elaborate Early Clinical Development Plans (Phase I–II) or contribute to later-stage plans (Phase IIb–IV).
• Write and review clinical sections of regulatory and safety documents (e.g., Investigator’s Brochure, IMPD, Briefing Books, DSUR, and NDA sections).
• Draft scientific queries and responses for Independent Ethics Committees (IEC/IRB) and Health Authorities (HA).
• Data & Science Expertise:
• Perform PK, PD, and PK/PD data analyses (using WinNonlin or equivalent software), data interpretation, data review prior to database lock, and graphical presentations.
• Maintain up-to-date scientific knowledge related to assigned compounds and conduct supportive literature reviews.
• Prepare or contribute to scientific publications, position papers, and congress presentations.
• Compliance & Governance: Ensure strict adherence to internal SOPs, quality control procedures, ICH-GCP guidelines, and local regulatory requirements.
• Stakeholder Management: Build and maintain collaborative relationships with Investigators, Key Opinion Leaders (KOLs), and internal matrix teams.

Minimum Qualifications & Experience

Education

• Required: Master’s degree (MSc or equivalent) in Life Sciences, Pharmacy, Pharmacology, or a related field.
• Preferred: Doctorate degree (PhD, PharmD, or MD) with a strong academic background in Clinical Pharmacology or related discipline.

Experience & Technical Skills

• Industry Experience: At least 1–2 years of clinical research experience within a pharmaceutical/biotechnology environment (drug development context preferred).
• Clinical Pharmacology: Proven experience in designing, conducting, analyzing, and interpreting CP trials and PK/PD data.
• Software Competency: Proficiency in PK/PD analysis software (e.g., WinNonlin/Phoenix) and standard IT applications (MS Office).
• Regulatory Awareness: Strong understanding of ICH-GCP guidelines, regulatory authorization processes, and trial execution requirements.
• Project & Multi-Tasking Management: Strong organizational skills with the ability to prioritize tasks and adapt dynamically in a fast-paced environment.