Clinical Project Manager

Job description
Come join Bioinvent as a Clinical Project Manager! You will have the chance to join a company who covers all aspects of drug development, including discovery, preclinical and translational research, manufacturing, and clinical development translating cancer antibody biology into innovative immuno-oncology therapies. Together we are creating the exciting future of BioInvent, and we welcome you to be part of it!

Responsibilities
As Clinical Project Manager at Bioinvent, some of your main responsibilities will include:

• Managing and leading all aspects of clinical study projects from study planning to close-out and study report

• Working closely with cross functional teams at Bioinvent (e.g. with manufacturing, pre-clinical, regulatory affairs, clinical    pharmacology)

• Selection and oversight of performance of Clinical Research Organizations (CROs) and other vendors

• Oversight and regular reporting of study progress to ensure successful completion within agreed timelines/ milestones and  budget

• Study site selection and performance and participation in site visits 

• Participate in establishing, monitoring, and maintaining procedures to ensure program meets all GCP/ICH Guidelines 

• Supporting in maintaining BioInvent’s relationship with KOLs and PI’s

• Co-development and review of study documents

• Routinely review of study data and progress of EDC entry; working with data management and clinical sites to resolve data 

The position is office based in Lund, however also offer a flexible working arrangement.   

Qualifications
To be happy and successful in this role we think that you bring the following experience:

• A MSc or PharmD in a life science discipline

• At least 5 years´ work experience as a Clinical Project Manager and/or Clinical Trial Manager, with a minimum of three years  leading a clinical study

• Experience in early phase studies

• Knowledge in oncology

• Experience in managing multiple project functions both internally and externally

• Experience in managing and meeting time plans and budgets as well as contract negotiations

• Deep knowledge about ICH-GCP and other relevant regulations to conduct clinical trials

• Excellent verbal and written communication skills in English

• Proficiency in MS Office tools

You will spark even more curiosity with is if you have knowledge in hematology and/or if you have experience in late phase studies. It will also bring extra value if you have a PhD.

We are looking for a mature and balanced professional, who takes accountability for assigned projects and drive them with great energy. Someone who enjoys sharing knowledge and insights, sees themselves as a sociable team player who is supportive for the people around him/her. You bring curiosity and a detail orientation in the way you lead. We also believe that you lead with clarity and a fearlessness in getting things done, of course contributed with great communication skills. Personal suitability and high integrity is of great importance, we nurture a culture of teamwork, positive team spirit and promote the development of each member in the team.

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
In this recruitment, Bioinvent collaborates with Randstad Life Sciences. For questions regarding this role, please contact recruitment consultant Karolina Andersson, karolina.andersson@randstad.se or +46705736613.

Please submit your application in English as soon as possible, and no later than January 17th. Applications are handled continuously, and the position may be filled prior to the last application date. 

About the company
BioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently three drug candidates in four ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors, respectively. The Company’s validated, proprietary F.I.R.S.T™ technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company’s own clinical development pipeline or for additional licensing and partnering.

The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company’s fully integrated manufacturing unit.