Senior Director Clinical Development

Senior Director Clinical Development – Life Science, Coopers Group AG

Contract duration: 1 year / possible extension

As Senior Director Clinical Development
, you will be a key member of the interdisciplinary development team, contributing effectively and independently to clinical development of assigned assets. This high‑visibility leadership role directly reports to the Head of Clinical Development, Basel Site.

You will lead clinical development activities related to the design, execution, and interpretation of clinical trials and the clinical development plan. You will work with the study management teams, train internal and external staff, monitor clinical data, and respond to health authority requests related to the assigned clinical development activities.

• Participate in and lead clinical development, both as individual contributor and leader.
• Create and guide clinical development strategy and formulate Clinical Development Plan (CDP), possibly leading a cross‑functional team to evaluate and integrate regulatory, safety, and timeline considerations.
• Lead and contribute to preparation of key study documents, including but not limited to study protocols and amendments, statistical analysis plans, clinical study reports, and regulatory filing documents.
• Lead and contribute to sponsor oversight of clinical trial execution, ensuring data quality and subject safety through trial medical monitoring or medical oversight of the studies and CROs. Assess impact of results on the development strategy and present conclusions to management.
• Interact with external stakeholders: assess and support the logistics and execution of clinical and preclinical research aligned with the clinical development or medical affairs strategy, including external research collaborations and investigator‑initiated research. Support the scientific communication and publication strategy. Interact with regulatory agencies, e.g., reporting requirements (DSUR, INDSR, etc.) and regulatory submissions.

• Education: MD and at least eight years of experience in clinical drug development.
• Proven experience in design, conduct, and data analysis of registration‑track global clinical trials. Experience designing and conducting rare disease clinical trials is strongly preferred.
• Substantial experience as an academic principal investigator for industry‑sponsored trials can be considered.
• Knowledge of regulatory requirements governing clinical trials and extensive experience in development of and writing of registration‑track clinical trial protocols and other trial‑related documents.
• Experience in interactions with ethics committee, regulatory authorities, and other external agencies.
• Previous experience providing oversight to vendor activities including CROs. Preferably board certified (or foreign equivalent) in Gastroenterology and/or Hepatology, Internal Diseases, or Pediatrics, but candidates with backgrounds in other medical specialties who have sound clinical research experience will be considered.
• Proven knowledge of clinical research methodology and biostatistics principles; ability to analyze and interpret clinical and efficacy data and develop formal written reports and presentations of those data internally and externally.

Director

Contract

Science

Pharmaceutical Manufacturing and Biotechnology Research