Idorsia seeks a Clinical Development Lead in Allschwil to provide scientific leadership for clinical studies, ensuring high-quality evidence and strategic development decisions for its medicines.
This position delivers clinical and scientific direction across the entire lifecycle of clinical studies, from design through execution and data interpretation. The role is pivotal in converting scientific insights into robust clinical evidence that drives development decisions. It also involves shaping evidence generation strategies to maximize the value of differentiated medicines.
Responsibilities
- Provide scientific guidance and strategic oversight for the multidisciplinary Clinical Team at the development program level.
- Develop innovative clinical strategies that optimize the compound's value throughout its lifecycle.
- Oversee the scientific writing and delivery of clinical sections for regulatory documents at both trial and program levels.
- Collaborate with key functions to lead thought leadership in clinical trial design and execution.
- Review, interpret, and communicate clinical trial data to inform ongoing program strategy.
- Act as a core member of the Safety Management Team, contributing to the assessment and communication of the benefit-risk profile.
- Assist in preparing safety-related documentation, such as Periodic Safety Update Reports and Drug Safety Update Reports.
- Lead clinical contributions to scientific communications, including abstracts, posters, presentations, and manuscripts.
- Represent the company as a credible scientific leader in interactions with investigators, experts, advisory boards, and Health Authorities.
Requirements
- Advanced degree in life or health sciences, such as a PhD, MD, PharmD, MSc, or equivalent.
- Minimum of eight years of relevant experience in clinical development within the pharmaceutical or biotechnology sector.
- Demonstrated experience leading Phase II to IV clinical development programs in global, cross-functional matrix environments.
- Strong background in supporting global regulatory submissions and interacting with Health Authorities.
- Comprehensive understanding of global drug development processes and innovative clinical trial design across all phases.
Nice to have
- Experience in pediatric development.
About the company
Idorsia challenges established medical paradigms with the goal of discovering, developing, and commercializing transformative medicines. The organization fosters an entrepreneurial, collaborative, and fast-moving environment. It leverages diversity, authenticity, and inclusion to drive business success.
- Challenges accepted medical paradigms to discover and commercialize transformative medicines.
- Fosters an entrepreneurial, collaborative, and fast-moving work environment.
- Harnesses the power of difference, authenticity, and inclusion to achieve business success.
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.