Global Clinical Trial Manager
vor 3 Wochen
Debiopharm is a privately-owned Swiss biopharmaceutical firm dedicated to advancing research in oncology and infectious diseases to enhance patient outcomes and quality of life. Debiopharm International SA focuses on developing innovative therapies through our unique "development only" business model, bridging the gap between groundbreaking discovery products and patient access in global markets. At Debiopharm, you will be at the forefront of the battle against cancer and infectious diseases by working on pioneering medicines for patients.
We are seeking a skilled and experienced Global Clinical Trial Leader with a strong commitment to advancing oncology research and a proven ability to lead and innovate in the realm of oncology clinical trials. In this role as
Global Clinical Trial Leader Early Phase
, you will have the chance to guide a dynamic and collaborative Global Clinical Trial Team. As the key driver behind cross-functional interactions, you will provide essential direction and guidance to ensure the seamless execution of trials.
Your key responsibilities will include:
Overseeing the planning, execution, and management of global clinical trials in oncology from initiation through to completion. Collaborating with cross-functional teams, including clinical operations, clinical development, regulatory affairs, and data management, to ensure the successful implementation of clinical trial protocols. Developing and managing clinical trial budgets, timelines, and resource allocations, ensuring compliance with quality standards and regulatory requirements. Engaging with key stakeholders, including CROs, investigators, key opinion leaders, and study sites, to foster strong relationships and effective communication. Monitoring trial progress, identifying and addressing potential issues, and implementing corrective actions as necessary. Staying informed about industry trends, regulatory guidelines, and scientific advancements in oncology, incorporating relevant knowledge into trial strategies. Contributing to the development of clinical development plans and study protocols, ensuring that clinical trials are inspection-ready at all times and that the Trial Master File (TMF) is complete with ongoing quality control activities. Assisting in process improvements and acting as a Subject Matter Expert for SOP development, updates, or training. Providing mentorship to new Clinical Trial Leaders during their onboarding process as assigned.Qualifications:
Advanced degree in a relevant scientific discipline (MD, PhD, or equivalent). Extensive experience in global clinical trial management, particularly in oncology project management. Demonstrated success in leading global clinical trials from inception to completion, primarily in Phase I & Phase II. In-depth knowledge of GCP, ICH guidelines, and other pertinent regulatory requirements. Experience with health authority inspections (FDA/EMA) and audits is preferred. Strong leadership and communication skills, with the ability to collaborate effectively across diverse teams and cultures. Exceptional organizational and problem-solving capabilities. Proficiency in project management tools and systems. Demonstrated ability to effectively forecast and manage trial budgets. Fluency in English (knowledge of French and another European language is an asset).Benefits:
International, highly dynamic environment with a long-term vision. Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry. Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry. Participation in a company where innovation, people, and entrepreneurship are fundamental keys to success. Proud to be an Equal-Pay certified organization, ensuring equal opportunities for all employees.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.
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