Debiopharm Group™ is a Swiss-based global biopharmaceutical group of five companies active in the development and manufacture of drugs and diagnostics tools. Debiopharm focuses on developing prescription drugs that target unmet medical needs. The group in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.
For our Clinical Safety and Pharmacovigilance team in the Research and Development department based in Lausanne we are looking for a:
(100% - permanent contract)
In this role, you will be responsible for actively managing and evaluating risks associated with products in development 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 main responsibilities:
- Evaluates and establishes the safety profile of Debiopharm compounds in development in collaboration with the different company experts and/or partner vendors
- Provides medical input with respect to safety aspects of the design and preparation of protocols, investigator brochures, study protocols, Development safety update reports
- Responsible for safety surveillance activities for products in development including medical review of individual safety cases and signal detection activities (ongoing review of safety data)
- Responsible for the medical aspects of assigned healthy volunteers clinical pharmacology studies, including first-in-human studies (SAD, MAD), clinical drug-drug interaction, TQT, special populations PK and ADME studies;
- In collaboration with Clinical Operations and Program Medical Director when applicable, monitor drug safety in early clinical phases and in late clinical pharmacology studies in healthy volunteers or patients.
- Collaborates with Clinicians, Biostatisticians, Translational Medicine, Clinical Operations and Regulatory functions to ensure that clinical programs will support robust safety assessment of our investigational compounds
- Develop, in collaboration with the relevant functions within Translational Medicine and Clinical Research & Development, the methodology for safety monitoring in clinical trials.
- Be a member of the global project teams and work in a collaborative and proactive way in a matrix environment.
- Participates in IDMC meeting or other safety related interactions with outside collaborators, and in internal safety task forces
- Responsible for reviewing documentation intended for regulatory submissions, including the relevant sections of INDs and NDAs.
- M.D., with experience in clinical safety in early clinical phases of drug development in a global pharmaceutical or global CRO
- At least 5-8 years of direct experience in Biotech/Pharmaceutical industry in clinical safety
- Experience in hepatic and cardiac safety management
- Hands-on experience in authoring regulatory documentation; experience in attending regulatory meetings an asset
- Experience in anti-infective or oncology drug development and/or in clinical pharmacology is considered a plus
- 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
- Proficiency in speaking, comprehending, reading and writing English is required
- Must possess computer skills by using MS Word, Excel, and Microsoft Outlook
Debiopharm can offer you:
- An international and highly dynamic environment, with a long term vision
- The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry
- The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.