Global Clinical Trial Leader

Vor 7 Tagen

Lausanne, Waadt, Schweiz Debiopharm Vollzeit


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:

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


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.

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