Safety Physician (Temporary 12 months)
Debiopharm Group, Switzerland

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and bacterial infections in order to improving patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.

Here: https://apply.workable.com/debiopharm-group-sa/

Debiopharm International S.A. identifies high-potential compounds for in-licensing, conducts clinical development and then selects large pharmaceutical commercialization partners to maximize patient access across the globe.

Safety Physician (Temporary 12 months)

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 amp; Drug Metabolism team.

Your main responsibilities:

• 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

• 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
• Experience in hepatic and cardiac safety management,
• First experience in oncology drug development
• 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
• Must possess computer skills by using MS Word, Excel, and Microsoft Outlook
• Ability to function effectively in high-stress situations
• Demonstrate excellent written and verbal communication skills in English and French;

Benefits

• Possibility to work from home with 1-2 site visits/month to the office (Lausanne)
• The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry and be exposed to many areas within clinical development and the pharmaceutical industry.
• The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.

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.

Job Rewards and Benefits