Senior Clinical Pharmacologist

Idorsia seeks a Senior Clinical Pharmacologist in Allschwil to lead clinical pharmacology strategy for early-stage programs, ensuring robust study design and dose selection across multiple projects.

This position supports Global Clinical Development by shaping the clinical pharmacology strategy for a high volume of First-in-Human and early clinical studies. The specialist works within a lean, fast-paced setting, collaborating closely with Translational Research to de-risk drug development and accelerate timelines through innovative approaches.

Responsibilities

• Oversee the creation and implementation of clinical pharmacology strategies for various programs.
• Establish dose selection criteria, escalation plans, and exposure-response profiles.
• Design clinical trials incorporating suitable pharmacokinetic (PK) and pharmacodynamic (PD) endpoints.
• Integrate data from nonclinical, translational, biomarker, and clinical sources to guide development choices.
• Utilize model-informed drug development (MIDD) and biomarker strategies to optimize study designs.
• Draft and refine protocols, including statistical and modeling components.
• Act as the main liaison for clinical pharmacology with Translational Sciences, Biostatistics, Research, and Regulatory Affairs.
• Provide strategic input during program governance meetings and lifecycle discussions.
• Manage a portfolio of new clinical candidates while maintaining oversight of active studies.
• Prepare regulatory submissions such as INDs, CTAs, briefing documents, and health authority responses.
• Represent the team as a subject matter expert during interactions with regulatory agencies.
• Supervise external service providers, including CROs and modeling vendors.

Requirements

• PhD, PharmD, MD, or equivalent degree in Clinical Pharmacology, Pharmacokinetics, or a related discipline.
• At least ten years of relevant industry experience within biotechnology or pharmaceutical sectors.
• Strong background in early clinical development phases, from First-in-Human through proof-of-concept.
• Demonstrated expertise in clinical study design and dose justification.
• Proficiency in PK/PD modeling and data interpretation.
• Ability to handle multiple concurrent programs in a dynamic environment.
• Track record of publishing high-quality manuscripts, abstracts, and conference presentations based on clinical pharmacology data.

What the company offers

• Chance to lead innovative early-stage initiatives with significant ownership and visibility throughout the organization.
• Employment within a science-driven company known for delivering innovative medicines from discovery to market.

About the company

Idorsia operates as a science-led organization that prioritizes innovative development processes over bureaucratic hurdles. The company fosters a culture that values difference, authenticity, and inclusion to drive business success.

• Prioritizes innovative development methodologies over rigid bureaucracy.
• Promotes an inclusive environment that leverages diversity and authenticity for business achievement.