Location: Switzerland - Glattbrugg/Zurich
Function: Research and Development
Company: Vifor Pharma
We are currently hiring our Head of nonclinical toxicology to join our dynamic team. In this role, you will be a key player to lead and develop a nonclinical toxicology team within our rapidly evolving organization, as well as provide scientific expertise in nonclinical toxicology.
Your responsibilities will include:
- Preparation of nonclinical contributions to regulatory documents in collaboration with internal team and external consultants, e.g. nonclinical documents for Common Technical Document (CTD), Investigator’s Brochure, labels, expert statements, answers to questions and meet with Regulatory Agencies/Health Authorities
- Represent nonclinical R&D in cross-functional teams and boards
- Provide toxicological risk assessments and support to toxicological questions from other departments, e.g Regulatory Affairs, Quality Assurance, Manufacturing
- Act as nonclinical expert and support Vifor Pharma’s partners
- Prepare nonclinical safety plans that support clinical trials and market applications
- Manage nonclinical toxicology studies , in particular regulatory studies performed under GLP at Contract Research Organizations (CROs) throughout all phases of development
- This includes CRO identification and selection, input to protocol, monitoring of study, resolution of technical and scientific issues, input to and review of draft study reports to ensure final report of high quality
- Organize and perform audits in collaboration with internal Quality Assurance
- Support toxicology/safety aspects of pipeline research
- Lead a small team of scientific experts
We would like to welcome the following experience and skills for the role:
- DVM or PhD in life sciences with toxicology expertise or equivalent
- 5+ years experience as nonclinical toxicology and safety expert in the pharma or biotech industry
- Expertise in toxicology, pharmacology and pharmacokinetics
- Excellent understanding of regulatory processes and guidelines
- Expertise in GLP
- Experience in leading a team of scientific experts
- Experience in working in cross-functional teams and in an international environment
- Excellent command of English, both oral and written
Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives. Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world. The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.
Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.
For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are.