Are you a person with strong pharmaceutical background with emphasis on pre-clinical development who is ready for a new challenge? We are looking for a Project Manager Preclinical Development for a long term assignment at Albireo to provide overall preclinical and nonclinical support for their programs in all phases of drug development.Albireo is a clinical-stage biopharmaceutical company focused on the development and potential commercialization of novel bile acid modulators to treat orphan pediatric liver diseases and other liver or gastrointestinal diseases and disorders. They have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. The parent company, Albireo Pharma, Inc., is located in Boston, Massachusetts and our key operating subsidiary, Albireo AB, is located in Gothenburg, Sweden.
The role includes following responsibilities:
- Provide overall preclinical and nonclinical support including design, execution, supervision, analysis, interpretation and reporting of non-clinical and clinical pharmacodynamics, toxicology and safety studies
- Engage, oversee and build collaborations with contract research organizations (CRO) to run and execute nonclinical studies.
- Support the filing of applications to regulatory agencies by preparing reports and appropriate sections of regulatory documents.
- Provide scientific insight and input from a nonclinical perspective to drive and improve the current drug development programs.
- Go through outcome reports and share the responsibility of writing summaries.
- Scientific degree e.g. Engineering, Biotechnology, Molecular Biology, Pharmaceutics or other relevant area.
- At least 7 years hands-on experience in drug development in relevant areas as described above
- Comprehensive understanding of the pharmaceutical/drug development process
- Good communicator with experience of interacting effectively across interfaces
- Excellent written and verbal communication skills in English.
- Strong collaboration skills
- Experience in running or managing IND-enabling studies and programs.
- Experience in working in close collaboration with CROs and consultants
- Experience and knowledge of pharmacokinetics and drug metabolism would be highly beneficial.
- Experience in running or managing toxicology studies.
We put high importance in personal qualities. You appreciate and sees the opportunities of working with a smaller pharmaceutical company. Candidates should possess good interpersonal skills and be strong team players. You should be able to work independently, take own initiatives and have a positive, goal oriented and problem solving attitude. It is essential that you are thorough and deliver with high quality. Furthermore we see that you have good organizational and communication skills.Business: Dfind Science & EngineeringCity: Gothenburg Assignment: Start as soon as possible. Initially 9 months with possibilities for a long term contract.Deadline for application: 2018-04-31. Since selection is done continuously we prefer receiving your application as soon as possible. More information: Karolina Schiötz +46733434018 firstname.lastname@example.orgOrganization/Business description:
Dfind Science & Engineering is a recruitment and consulting company within science and engineering. All our consultant managers and recruitment consultants have an education and work experience within the respective field. In combination with extensive knowledge of staff issues and solid experience of recruitment, this means that we understand our clients' need for both flexibility and the right skills. Dfind Science & Engineering is since 2016 part of Randstad Group. With over 600 000 employees in over 40 countries Randstad is the work second largest company within recruiting and staffing.