P2620 - Safety Physician Oncology

Debiopharm; Lausanne; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Benefits dieser Stelle

International, dynamic environment

Cross-functional collaboration at the尖

Exposure to diverse clinical areas

Innovation and entrepreneurship

Equal-Pay certified

Zusammenfassung

Debiopharm is seeking a Safety Physician Oncology to join the Clinical Safety and Pharmacovigilance team in Lausanne. The role is 100% and permanent, based at the Lausanne HQ.

You will manage safety profiles for oncology and antibiotics, support early-phase healthy volunteer studies, and collaborate across functions. Requirements include an MD with 5+ years in clinical safety in biotech/pharma, with oncology exposure as an asset, plus strong leadership, communication, and English skills; French

Qualifikationen

• MD degree with clinical safety experience in early clinical phases.
• Minimum 5 years in biotech/pharma clinical safety.
• Experience in oncology drug development is an asset.
• Strong leadership and collaboration skills.

Aufgaben

• Evaluate safety profile in collaboration with experts and partners.
• Provide medical input for safety documents (e.g., accelerated approval, investigator brochures, development safety update reports).
• Lead safety surveillance activities and medical review of cases in safety database; signals monitoring.

Kenntnisse

Leadership

Collaboration

Communication

Decision making

Microsoft 365

English

French (asset)

Prioritization

Ausbildung

MD degree

Tools

Microsoft 365

Jobbeschreibung

For our Clinical Safety and Pharmacovigilance team in the Research and Development department based in Lausanne we are looking for a:

For our Clinical Safety and Pharmacovigilance team in the Research and Development department based in Lausanne we are looking for a:

Safety Physician Oncology

100%, Permanent contract, in Lausanne HQ.

In this role, you will be responsible for actively managing and evaluating risks associated with products in development in oncology and also antibiotics under the responsibility of the Head of Clinical Safety and Pharmacovigilance. You will also support deployment of the early phases in healthy volunteers in collaboration with the Clinical Pharmacology & Drug Metabolism team

Your responsibilities will be but not limited to:

• Evaluate and establishes the safety profile of this product in collaboration with the different company experts and/or partner vendors
• Provide medical input with respect to safety aspects of :
  • the documents intended to be submitted in an accelerated approval procedure,
  • preparation of investigator brochures,
  • Development safety update reports
• Be responsible for safety surveillance activities for this product including medical review of individual safety cases directly in the safety database and signal detection activities (ongoing review of safety data)
• Ensure the oversight of medical activities outsourced to our PV vendor
• Develop and lead, in collaboration with the relevant functions within clinical medicine, biometry and clinical pharmacology the implementation of a signal detection tool.
• Be a member of study teams and work in a collaborative and proactive way in a matrix environment.
• Participate in IDMC meeting or other safety related interactions with outside collaborators, and in internal safety task forces

Requirements

Your profile

• M.D., with experience in clinical safety in early clinical phases of drug development in a global pharmaceutical or global CRO
• At least 5 years of direct experience in Biotech/Pharmaceutical industry in clinical safety
• First experience in oncology drug development, in early stages an asset
• Excellent leadership, management, collaboration, communication and decision making skills
• Able to prioritize activities effectively and to meet multiple deadlines successfully with attention to detail, setting high performance standards for quality
• Master Microsoft 365 suite, appetite for digital tools a plus
• Demonstrate excellent written and verbal communication skills in English, French an asset

Benefits

Debiopharm offers employees:

• 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