Clinical Pharmacology Lead
Key information
- Publication date:18 September 2025
- Workload:100%
- Contract type:Unlimited employment
- Place of work:Pratteln
Job summary
Santhera Pharmaceuticals is a Swiss company focusing on innovative treatments. Join us to impact lives with rare neuromuscular diseases.
Tasks
- Lead design and execution of clinical pharmacology studies.
- Develop comprehensive strategies for drug development and submissions.
- Oversee PK/PD modeling and collaborate across teams for success.
Skills
- Advanced degree in pharmacology or related field; 7-10 years of experience.
- Deep understanding of drug development and regulatory requirements.
- Strong analytical skills and excellent communication abilities.
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Clinical Pharmacology Lead
Location: Pratteln, Switzerland (Hybrid) Scope of Work
The Clinical Pharmacology Lead will be responsible for designing and executing clinical pharmacology strategies across early and late-stage drug development programs. This role will provide scientific and strategic leadership in the planning, analysis, and interpretation of pharmacokinetic (PK), pharmacodynamic (PD), and exposure-response studies to support clinical development and regulatory submissions. The position requires cross-functional collaboration with clinical development, regulatory affairs, biostatistics, preclinical development, and other stakeholders to ensure that clinical pharmacology plans align with program objectives and regulatory expectations. Key Responsibilities
- Lead the design, execution, and interpretation of clinical pharmacology studies (e.g., FIH, dose-finding, DDI, special populations, bioavailability/bioequivalence).
- Develop and implement comprehensive clinical pharmacology strategies to support clinical development plans and regulatory submissions.
- Oversee PK/PD modelling, population pharmacokinetic analyses, and exposure-response evaluations in collaboration with modelling & simulation teams.
- Provide scientific input for protocol design, clinical study reports, investigator brochures, and regulatory documents.
- Represent clinical pharmacology in cross-functional project teams and contribute to strategic decision-making.
- Interact with regulatory authorities, prepare briefing packages, and respond to information requests related to clinical pharmacology.
- Coordinate cross-functional teams to ensure timely delivery of milestones within financial constraints.
- Ensure adherence to ICH, FDA, EMA, and other relevant guidelines for clinical pharmacology and pharmacometrics.
- Prepare external presentations and publications.
- Advanced degree (PhD, PharmD, or MD) in pharmacology, pharmaceutical sciences, clinical pharmacology, or a related discipline.
- Minimum of 7-10 years of relevant industry experience in clinical pharmacology, pharmacometrics, or drug development.
- Demonstrated leadership in designing and implementing clinical pharmacology programs across multiple phases of development.
- Strong track record of contributing to successful regulatory submissions (IND, NDA, BLA, MAA).
- Hands-on experience with PK/PD data analysis and working knowledge of modeling and simulation software
- Deep understanding of clinical pharmacology principles, drug development process, and regulatory requirements.
- Strong analytical and problem-solving skills, with the ability to integrate complex data into actionable insights.
- Excellent written and verbal communication skills, with the ability to convey scientific concepts to both technical and non-technical stakeholders.
- Strategic thinker with the ability to influence decision-making and drive clinical development plans forward.
- Strong organizational and project management skills, with the ability to manage multiple priorities in a fastpaced environment.
- Commitment to scientific rigor, quality, and innovation.
