Preclinical Development Manager
Pure Biologics Inc. is solid and quickly developing biotech company located in one of the most beautiful and perspective cities in Europe. We work on treatment of lifestyle diseases using cutting-edge technologies. The company laboratory area is over 600m2 furnished with state-of-the-art equipment for biochemical and biophysical analysis (DNA aptamers, proteins), cell and bacterial cultures, protein production and storage systems. Pure Biologics has acquired substantial public and private funding to support its efforts aimed towards the development of new biologic drugs in the field of immunooncology and rare diseases.
Pure Biologics Inc. is seeking a qualified applicant to fill a position of:
Preclinical Development Manager
This position comprises design, overseeing, managing and analysis of the results of preclinical studies of new biologic assets in animal models in the field of immunooncology, performed by external subcontractors. This includes pivotal in vivo research, early pharmacology and toxicology studies, as well as studies aiming at fulfilling the regulatory submission criteria. If you feel eager to support the growth of our company with your knowledge and experience in oncology and preclinical studies, and you’re willing to take on a self-reliant and highly independent responsible position, we gladly welcome your application.
- Defining the strategy and scope of pharmacology studies for new biologic assets mainly in the immunooncology field
- Evaluation of ideas and models for the relevant preclinical development of new biologic assets
- Designing comprehensive protocols for in vitro and in vivo preclinical studies according to EMA/FDA requirements
- Assistance with the integration of initiatives with project managers, drug discovery scientists and higher management, as well as with external experts and subcontractors
- Managing of the transition from the drug discovery phase to the preclinical development, as well as from the preclinical development to Phase I/PoC clinical trials
- Evaluation and selection of the subcontractors (academic or CRO) partners for the placement of preclinical studies
- Monitoring and managing of the outsourced preclinical studies by direct contact with the subcontracted party, planning and definition of timelines, milestones and budgets
- Review, analysis and evaluation of results and reports issued by subcontractors performing the preclinical studies
- Participating in the preparation of regulatory documentation for new biological assets entering the clinical trials phase
- Public presentation of preclinical studies results to scientists and investors
- A relevant degree (MSc or PhD) in life sciences discipline, e.g. Pharmacology, Toxicology
- Solid understanding of biologic drug development process is mandatory,
- Scientific focus on preclinical research in immunooncology will be highly beneficial
- Proven ability to apply pharmacological principles to the preclinical phase of the drug development
- Minimum 4 years of industrial experience in the preclinical studies sector, including regulatory submission-aimed preclinical development studies
- Knowledge of the GLP requirements for nonclinical pharmacology/toxicology
- Strong communication (both written and verbal) and interpersonal skills
- Ability to work flexibly in a dynamic and collaborative environment
- Independence and responsibility in decision making and task execution
- Good oral and writing English skills
- High personal culture and work ethics
The company offers:
- Secure long-term employment based on a job contract with undefined duration
- Access to private medical care and subsidized life insurance
- Opportunities for constant professional and personal development
- Participation in trainings, workshops, conferences
- Friendly work environment
- Access to Multisport activity card
- Fresh fruits every Tuesday and soft drinks 24/7.
- Cinema tickets for those who commute to work by bike.
We encourage all interested applicants to submit an application using the FORM. Please submit the documents in English (CV and a cover letter). The deadline for submitting applications is 31/05/2019. Selected candidates will be invited for an interview.