Country Dirctor / Clinical Project Manager
Posted on Mar 16, 2019 by Barrington James Clinical
Location: Poland - Krakow or Warsaw
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.
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
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!