Clinical Pharmacology Lead
Santhera Pharmaceuticals (Schweiz) AG
Pratteln
Key information
- Publication date:18 September 2025
- Workload:100%
- Contract type:Permanent position
- Place of work:Pratteln
Santhera Pharmaceuticals is a Swiss specialty pharmaceutical company focused on medical science and the development and commercialization of innovative pharmaceutical products for the treatment of rare neuromuscular diseases with high unmet medical need. For further information, please visit the Company's website www.santhera.com Come and join our team to contribute to providing treatment options for patients with rare diseases that have a severe impact on the lives of affected children and adults. You can make a difference as:
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
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.
