Senior Safety Physician (P2341)

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve 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. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first 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.

At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target.

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

For our Clinical Safety and Pharmacovigilance organization based at our Headquarters in Lausanne, we are looking for a

Senior Safety Physician

In this single contributor role, you will be responsible for actively managing and evaluating risks associated with products in development (phase 1 to phase 3 studies) under the responsibility of the Head of Clinical Safety. The Sr. Safety Physician will also support deployment of the early phases in healthy volunteers in collaboration with Translational Medicine Clinical Pharmacology & Drug Metabolism team. The Senior Safety Physician is expected to perform his/her responsibilities independently, including participating in strategic health authority (HA) interactions and may be responsible for the management and supervision of a more junior Safety Physician.

Your responsibilities will be but not limited to:

• Accountable for the successful evaluations and establishing the safety profile of Debiopharm products in collaboration with the different company experts and/or partner vendors and communicates the strategy at the project team level
• Provides 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
• Responsible for safety surveillance activities for assigned products including medical review of individual safety cases and signal detection activities as part of the continuous benefit-risk evaluation throughout the development of the compound Collaborates with Clinical Development, Biostatisticians, Translational Medicine, and Regulatory functions to ensure that clinical programs will support robust safety assessment of Debiopharm investigational compounds.
• Ensures the assigned work comply with established practices, policies and processes and any regulatory or other requirements.
• Ensures the oversight of medical activities outsourced to the selected Clin Safety vendor;
• Be a member of study 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 forcesResponsible for reviewing and providing safety input on documentation intended for regulatory submissions, including the relevant sections of INDs and NDAs.

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,
• 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

• Experience in anti-infective or oncology drug development and/or in clinical pharmacology is considered a plus,
• Being able to translate preclinical safety findings into the clinical development plan and to assess the impact dose selection and clinical dose recommendations on the characterization of the therapeutic index of the compound
• Hands-on experience in authoring r