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P2302 - Associate Scientist Preclinical Safety
vor 2 Wochen
Description
Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and bacterial infections 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. 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.
For our Translational Medicine organization based at our Headquarters in Lausanne, we are looking for a
Associate Scientist, Preclinical Safety
In this role, you participate in Preclinical Safety activities to add value to, support, and accelerate the development of Debiopharm’s innovative therapeutics in accordance with development plans, regulatory requirements and internal procedures and policies.
Your responsibilities will be but not limited to:
Contribute to the Preclinical Safety activities defined in the Translational Medicine Development plan for assigned projects
Monitor, analyse and report the non-clinical safety/toxicology and safety pharmacology in vitro and in vivo studies, related but not limited to:
Project preclinical safety program required for FIH and up to NDA submission in a GLP-compliant environment
Toxicology findings in preclinical and clinical studies (mechanistic studies)
Identification and method development/validation analyses of nonclinical surrogate toxicity markers
Monitor finance, budget and timelines related to assigned Preclinical Safety activities
Monitor external collaborations with international universities/scientific institutions (MTAs and sponsored research services)
Contribute to CRO selection, manage outsourcing activities
Identify potential intellectual property, inventions innovation and repositioning opportunities, and supports legal department to feed DPI’s patent portfolio
Support Regulatory Affairs, Market Intelligence & Market Access activities
Contribute to the preparation of the preclinical safety/safety pharmacology documentation (IB, summaries for IND and IMPD, briefing documentation)
In addition, and depending on projects, you may contribute to the Preclinical Safety portion of assigned clinical studies, the elaboration of the clinical development strategy, the preparation of IDB, IMPD, clinical protocol, and act as a representative of the Preclinical Safety function in Clinical Study teams and participate to Due diligence activities.
**Requirements**:
Master or PhD in biology, biochemistry, pharmacology, pharmacy, veterinary science
A first experience in working with Animal Welfare Regulations (incl. 3Rs) is a strong plus
Practical knowledge of GCP and ICH guidelines and relevant regulatory guidelines are preferred
You are a team player, high interpersonal and communication skills, solution-oriented and positive attitude
Fluent in English (spoken and written), French is an asset
Scientific curiosity and rigor, organizational skills
**Benefits**:
Possibility to work from home with monthly visit in 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.
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.
