Country Dirctor / Clinical Project Manager

Role: Country Director + Project Manager/Clinical Research Manager

Location: Poland – Krakow or Warsaw

Company: Biotech

I'm partnering a small, growing, global biotech as they look to advance their compounds through clinical development. They are developing novel biological treatments for a variety of immune-related diseases, therefore this is a great opportunity to be creating best-in-class drugs and helping patients globally. Following excellent results in IND enabling studies, they are searching for a Country Director and a Project Manager in Poland as they rapidly expand into the clinic. You will be working closely with the R&D team as well as the global Senior Management Team and will play a key role in the development of their key compounds.

In Summary

• Reporting to the Director Clinical Operations
• Manages ongoing and future NCBiR funded clinical programs
• Participates in the development of the organizations strategic plans for product development including the design, feasibility, and costing of studies and clinical trials to meet the organizationsgoals.
• Responsible for the management and overall success of assigned clinical program(s)
• Responsible for operational oversight, management, and delivery of one or more clinical development programs in support of development strategy;
• Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget
• Presents program/study(ies) overviews/status to CTM team
• Authors, provides input, and/or oversees program and/or study level documents;
• Responsible for leadership and management of one or more programs in Clinical Trial Management
• This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures
• Interacts with senior level management, funding sponsors, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives.
• Overall, the CRM is responsible for maintaining overview of clinical program status and strategy and communicating clinical program level updates to the CTM team
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Experience/Qualifications

• Life Sciences degree
• At least 5 years of demonstrated experience in clinical research, with focus on Phase I & II clinical trials
• Relevant experience in either a CRO or Pharmaceutical company
• For Country Director - Demonstrated experience in line management of teams comprising at least 10 people
• Demonstrated excellent communication, organizational, time-management and presentation skills in both Polish and English
• Ideally demonstrated experience in facilitating Polish government funded projects from The National Centre for Research and Development (NCBiR)
• Compliance management and team performance
• Reputable experience with Polish clinical research sites, R+D processes, legal, regulatory and ethics
• Demonstrated experience with multi-department budgets

For more information on these excellent opportunities, apply to this advert now!