Alligator Bioscience AB (Alligator) in Lund is seeking for a highly motivated Preclinical Safety Manager. The position is a full-time permanent position.
Alligator is a research-based biotechnology company founded in 2001. The company specializes in the development of antibody-based pharmaceuticals for cancer treatment. The company is primarily active in the early phases of drug development, from the idea stage to clinical phase II trials.Job description
Your essential tasks will be to:
- Design and conduct preclinical safety studies in immuno-oncology and to ensure that deliverables are met in time, at a high quality and within budget.
- Manage preclinical safety activities conducted at external preclinical CROs as sponsor contact, and with internal departments at Alligator (CMC, clinical, and quality) in order to coordinate the studies.
- Take part in selection and contracting of preclinical CROs, including handling the RFI/RFP process, compare study quotes and contract process.
- Develop and review relevant documents such as study protocols, study budgets etc.
- As sponsor representative, be responsible for the quality of studies performed at CROs, including studies conducted according to GLP or other quality guidelines.
- Be an essential part of project teams at Alligator, including participating in project meetings and contributing to project reports, risk management, budget and timelines.
- Depending on the background, competences and interests of the right applicant, these responsibilities may extend to include project management or other research activities.
We expect the ideal candidate to:
- PhD or MSc+5 years working experience within life sciences and preferably a strong background within immunology and/or immuno-oncology
- Have experience in managing preclinical safety studies, preferably in the biotech or pharma industry setting and for antibody drug candidates intended for the treatment of cancer.
- Have knowledge of relevant regulatory safety guidelines, and good overview of the drug development process.
- Excellent communication skills with ability to effectively communicate both orally and in writing.
- Be fluent in English, written and verbal.
- The candidate should be highly motivated, flexible, quality minded and enjoy working in a team-oriented environment and contribute to shared project and organizational goals.
We handle screening and selection ongoing and therefore encourage you to apply as soon as possible, but no later than June 26th 2018. Apply by clicking on "Sök tjänst". Please upload your CV and cover letter. All enquiries are treated confidentially. We don´t accept applications via email.
For further information regarding the role please contact Christina Furebring on tel. +46 46 286 42 83. If you have questions regarding the recruitment process please contact Johanna Isberg, tel +46 705 843383 or email email@example.com.
We look forward to your application!