For our Clinical Safety and Pharmacovigilance team in the Research and Development department based in Lausanne we are looking for a: Safety Physician Oncology100%, 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 vendorsProvide 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 forcesRequirementsYour 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 assetBenefitsDebiopharm 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 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.
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
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.
Debiopharm is an independent biopharmaceutical company based in Switzerland with headquarters in Lausanne(VD) and a manufacturing site in Martigny (VS).We are committed to developing innovative therapies that target high unmet medical needs in oncology and infectious diseases with a broad range of expertise in drug development, drug manufacturing as well as investment in start-ups. Through our unique business model, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.
Debiopharm is an independent biopharmaceutical company based in Switzerland with headquarters in Lausanne(VD) and a manufacturing site in Martigny (VS).
We are committed to developing innovative therapies that target high unmet medical needs in oncology and infectious diseases with a broad range of expertise in drug development, drug manufacturing as well as investment in start-ups.
Through our unique business model, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.
