Regulatory affairs director Jobs in Lausanne

Debiopharm is privately-owned Swiss biopharmaceutical company commitmented to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Debiopharm International SA aims to develop innovative therapies via our unique “development only” business model, acting as a bridge between disruptive discovery products and patient access in international markets. At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases through working on innovative medicines for patients. Join our team at Debiopharm where together, we innovate, we impact, and we grow.

Are you a dedicated and experienced Global Clinical Trial Lead with a passion for advancing oncology research, leading and innovating in the field of oncology clinical trials? Join our team as

Global Clinical Trial Leader Early Phase

You will have the opportunity to lead a dynamic and collaborative Global Clinical Trial Team. As the driving force behind cross-functional interfaces, you will provide invaluable direction and guidance to ensure flawless execution of trials.

Your responsibilities will be but not limited to :

• Lead the planning, execution, and management of global clinical trials in oncology from initiation to completion
• Collaborate with cross-functional teams, including clinical operations, Clinical Development, regulatory affairs, and data management, to ensure the successful implementation of clinical trial protocols
• Develop and oversee clinical trial budgets, timelines, and resource allocations, ensuring adherence to quality standards and regulatory requirements.
• Interface with key stakeholders, including CROs, investigators, key opinion leaders, and study sites, fostering strong relationships and effective communication
• Monitor trial progress, identifying and addressing potential issues, and implementing corrective actions as necessary
• Stay current with industry trends, regulatory guidelines, and scientific advancements in oncology, incorporating relevant knowledge into trial strategies
• Contribute to the development of clinical development plans and study protocols. Ensures clinical trial is inspection-ready at all time and Trial Master File (TMF) completion including TMF plan is in place and ongoing QC activities are performed to always ensure TMP completeness
• Contributes to process improvements or acts as Subject Matter Expert for SOP development / update or training.
• Coaches new Clinical Trial Leaders during their onboarding as assigned.

Requirements

Benefits

The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly in an attempt to present candidates.

Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.

Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.