Lead Clinical Pharmacologist - PK/PD & Early-Phase Trials

Flexsis; Allschwil; On-site; CHF 140,000 - 190,000; Full time

Job summary

Flexsis is seeking a Clinical Development professional to lead CP studies, design protocols, and oversee PK/PD evaluations in a regulated setting. You will coordinate cross-functional teams, contribute to regulatory documents, and ensure data integrity and timely delivery.

Applicants should have strong scientific writing skills, experience with PK/PD analysis tools, and the ability to communicate complex data to health authorities. Travel may be required.

Qualifications

• Experience designing, conducting, and analyzing CP studies.
• Understanding PK/PD evaluation techniques and regulatory guidelines.
• Knowledge of roles in drug development and cross-functional interfaces.
• Familiarity with ICH-GCP and regulatory guidance for trials.
• Strong data analysis, attention to detail, and scientific rigor.

Responsibilities

• Lead phase I/IIa studies including writing/review of protocols and trial-related documents.
• Contribute to regulatory/commercial documents (IB, IMPD, DSUR, NDA sections).
• Oversee data review prior to database lock and ensure quality.
• Develop CP trial plans and maintain project timelines and budgets.
• Collaborate across functions and attend to scientific inquiries from authorities.
• Prepare scientific publications and position papers as needed.
• Travel as required while maintaining organized documentation.

Skills

CP studies design

PK/PD evaluation

ICH-GCP knowledge

Drug development processes

Data analysis and interpretation

Team collaboration

Scientific writing

Communication skills

Tools

WinNonlin

Job description

Flexsis is seeking a Clinical Development professional to lead CP studies, design protocols, and oversee PK/PD evaluations in a regulated setting. You will coordinate cross-functional teams, contribute to regulatory documents, and ensure data integrity and timely delivery.

Applicants should have strong scientific writing skills, experience with PK/PD analysis tools, and the ability to communicate complex data to health authorities. Travel may be required.