Global Clinical Trial Management Leader
Vor 2 Tagen
Debiopharm, a privately-owned Swiss biopharmaceutical company, is committed to research in oncology and infectious diseases to improve patient outcomes and quality of life. We aim to develop innovative therapies through our unique "development only" business model, acting as a bridge between disruptive discovery products and patient access in international markets.
As Global Clinical Trial Leader Early Phase, you will have the opportunity to lead a dynamic and collaborative Global Clinical Trial Team. You will provide invaluable direction and guidance to ensure flawless execution of trials.
Your Key Responsibilities
- Plan, execute, and manage 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. Ensure clinical trial is inspection-ready at all times and Trial Master File (TMF) completion, including TMF plan, is in place and ongoing QC activities are performed to always ensure TMF completeness.
- Contribute to process improvements or act as Subject Matter Expert for SOP development/update or training.
- Coach new Clinical Trial Leaders during their onboarding as assigned.
Requirements
- Advanced degree in a relevant scientific discipline (MD, PhD, or equivalent).
- Extensive experience in global clinical trial management, including project management, specifically in oncology.
- Proven track record of successfully leading global clinical trials from inception to completion, mainly in Phase I & Phase II.
- In-depth knowledge of GCP, ICH guidelines, and other relevant regulatory requirements.
- Experience with health authority inspections (FDA/EMA) and audits preferred.
- Strong leadership and communication skills, with the ability to collaborate effectively across diverse teams and cultures.
- Exceptional organizational and problem-solving abilities.
- Proficiency in project management tools and systems.
- Demonstrated ability to effectively forecast and manage trial budget.
- Fluent in English (French and another European language are 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 the fundamental keys to success.
- Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities.
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