P2416 - Global Clinical Trial Leader

vor 1 Tag

Lausanne, Schweiz TN Switzerland Vollzeit

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P2416 - Global Clinical Trial Leader, Lausanne

Client: Debiopharm

Location: Lausanne

Job Category: Other

Job Reference: cdec27b0db6f

Job Views: 8

Posted: 21.01.2025

Expiry Date: 07.03.2025

Job Description:

Debiopharm is a privately-owned Swiss biopharmaceutical company committed to research in oncology and infectious diseases 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 include:

  • 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. 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 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).

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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