Clinical Pharmacologist

About the role

The Clinical Pharmacologist will lead early‑phase clinical pharmacology studies, providing scientific expertise to cross‑functional teams and supporting regulatory submissions throughout drug development.

Key responsibilities

• Lead Phase I and Phase IIa pharmacology trials, delivering protocols, study reports, statistical analysis plans and trial summaries on time and within budget.
• Develop clinical pharmacology trial plans, contribute to early‑clinical development strategies and write regulatory sections such as Investigator’s Brochure, IMPD and NDA.
• Perform PK, PD and PK/PD data analyses, interpret results, review data prior to database lock and create graphical presentations.
• Maintain up‑to‑date scientific knowledge, conduct literature reviews and contribute to publications, position papers and conference presentations.
• Ensure compliance with SOPs, ICH‑GCP guidelines and local regulatory requirements while managing relationships with investigators, KOLs and internal teams.

Required profile

• Master’s degree in Life Sciences, Pharmacy, Pharmacology or related field; PhD, PharmD or MD preferred.
• 1–2 years of clinical research experience in a pharmaceutical or biotechnology environment.
• Proven experience designing, conducting and interpreting clinical pharmacology trials and PK/PD data.
• Strong organizational skills with the ability to prioritize tasks in a fast‑paced, matrix environment.

Required skills

• Proficiency with PK/PD analysis software (e.g., WinNonlin/Phoenix).
• Competence in standard IT applications, especially MS Office.
• Solid understanding of ICH‑GCP guidelines and regulatory submission processes.