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Idorsia aims to challenge accepted medical paradigms by discovering, developing, and commercializing transformative medicines, evolving into a leading biopharmaceutical company with a strong scientific core. This role offers the opportunity to take scientific ownership of a clinical program, shape lifecycle evidence generation, and unlock the full potential of differentiated medicines through clinically meaningful, scientifically robust, and strategically aligned development activities. You will work closely with Clinical Operations, Regulatory Affairs, Drug Safety, Biostatistics, Medical Affairs, and Commercial colleagues to ensure development plans are scientifically robust, operationally feasible, and strategically aligned.

Tasks

  • Lead the multidisciplinary Clinical Team at development-program level, providing scientific direction, strategic alignment, and accountability across the program.
  • Shape innovative clinical development strategies that maximize the compound's value throughout its lifecycle, integrating emerging scientific evidence and evolving standard of care into development plans.
  • Lead the scientific development and delivery of clinical sections of trial- and program-level regulatory documents, including Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities.
  • Provide thought leadership in clinical trial design and execution in close partnership with key functions, ensuring scientific quality, clear prioritisation, and timely delivery.
  • Provide ongoing clinical and scientific review, interpretation, and communication of clinical trial data to inform program strategy and development decisions.
  • Serve as a core member of the Safety Management Team and contribute to the assessment and communication of the compound’s benefit-risk profile.
  • Support the preparation of safety-related documents, including Periodic Safety Update Reports, Drug Safety Update Reports, and other safety documentation, in collaboration with the Project Physician and Drug Safety Physician.
  • Maintain a strong understanding of the therapeutic area, competitive landscape, relevant mechanisms of action, and evolving standards of care.
  • Lead clinical contributions to scientific communications, including study abstracts, posters, oral presentations, and manuscripts.
  • Represent the Company as a credible scientific leader externally with investigators, scientific experts, advisory boards, and Health Authorities.
  • Champion the clinical perspective in cross-functional discussions and support the continuous evolution of the clinical development strategy.

Requirements

  • Advanced degree in life or health sciences, such as PhD, MD, PharmD, MSc or equivalent.
  • At least eight years of relevant experience in clinical development within the pharmaceutical or biotechnology industry.
  • Proven experience leading Phase II to IV clinical development programs in global, cross-functional matrix environments through successful planning, delivery, and publication.
  • Strong experience supporting global regulatory submissions and Health Authority interactions, including the preparation of key clinical and regulatory documents throughout the development lifecycle.
  • Excellent understanding of global drug development and innovative clinical trial design through all phases, with the ability to integrate preclinical, translational, clinical, and real-world evidence to inform development strategies; pediatric development experience is an advantage.
  • Intellectually curious with strong scientific acumen, entrepreneurial spirit, and learning agility, with the ability to challenge conventional thinking constructively.
  • Excellent written and verbal communication skills, with strong executive presence and the ability to effectively communicate complex scientific concepts to diverse internal and external stakeholders.
  • Strong project management, prioritization, problem-solving, and stakeholder-management capabilities.
  • Ability to work independently, influence decision-making, and build alignment across cross-functional teams in a dynamic matrix organization.
  • A collaborative, proactive, and pragmatic mindset, with a strong sense of ownership and commitment to delivering high-quality clinical evidence.
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Über uns
Idorsia Pharmaceuticals Ltd ist ein biopharmazeutisches Unternehmen mit Sitz in Allschwil. Das Unternehmen erforscht, entwickelt und vermarktet innovative Medikamente für Patientinnen und Patienten mit hohem medizinischem Bedarf. Idorsia konzentriert sich auf eigene Wirkstoffforschung, klinische Entwicklung und Kommerzialisierung ausgewählter Therapien. Die Forschungs- und Entwicklungsaktivitäten bauen auf langjähriger Erfahrung in der pharmazeutischen Wirkstoffentwicklung auf.
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